According to CCTV News, on April 8th local time, US President Trump announced in a speech that the United States will impose tariffs on pharmaceuticals. Trump stated that the United States does not produce its own medications and other health-improving products. The prices paid for drugs in the U.S. are often many times higher than those in countries that produce pharmaceuticals. Trump believes that once tariffs are imposed on medications, pharmaceutical companies will establish factories in the U.S. because it is the "largest market." European pharmaceutical companies warned at a meeting with the President of the European Commission on the 8th local time that US tariffs will accelerate the trend of the industry moving from Europe to the US. EFPIA, a pharmaceutical industry trade lobbying group whose members include European pharmaceutical giants Bayer, Novartis, and Novo Nordisk, said that it has called on the EU President to push for "rapid and fundamental action" to mitigate the risk of an exodus to the US.

Announcement by the National Medical Products Administration on the cancellation of registration certificates for 12 medical devices, including spinal internal fixation systems.(No. 33 of 2025)In accordance with the "Regulations on the Supervision and Administration of Medical Devices," and based on applications from enterprises, the National Medical Products Administration has now canceled the medical device registration certificates for a total of 12 products from the following 8 enterprises:1. The product of Kelin Tai Co., Ltd.: Spinal Internal Fixation System, Registration Certificate Number: Guo Xie Zhu Jin 20173136765.II. One product from Shanxi Yinuo Medical Technology Co., Ltd.: Single-use Negative Pressure Closed Drainage and Management System, Registration Certificate Number: National Medical Device Approval 20183140472.III. One product from Johnson Johnson Vision Care: Posterior Chamber PMMA Intraocular Lens, Registration Certificate Number: Guo Xie Zhu Jin 20163161337.Four, Cheng Shin Hsin Ye Corporation Taoyuan Plant Company has 1 product registered: Dental Zirconia Ceramic Block, registration number: National Medical Device Registration 20232170021.Five, Airon Medical Co., Ltd.'s three products: Gastrointestinal Nutritional Tube, registration number:国械注进20152141918; Gastric Stoma Length Gauge, registration number:国械注进20182141890; Radiofrequency Trocar, registration number:国械注进20223140375.VI. One product from Xiamen Xinkangshun Medical Technology Co., Ltd.: Disposable Hydrophilic Coated Guide Wire, Registration Certificate No.: National Medical Device Approval 20223031532.Seven, the two products of Spine Art Company: Cervical Anterior System, registration certificate number: National Medical Device Registration 20163132044; Lamina Fixator, registration certificate number: National Medical Device Registration 20163131692.8. Two products from Xi'an Ouzhong Material Technology Co., Ltd.: Dental laser selective melting cobalt-chromium alloy powder, registration certificate number: National Medical Device Registration No. 20203170572; Dental laser selective melting titanium alloy powder, registration certificate number: National Medical Device Registration No. 20213170503.　Hereby announced. National Medical Products AdministrationMarch 27, 2025

This year's Government Work Report explicitly proposed to "optimize the centralized procurement policy, strengthen quality assessment and supervision." In 2025, China's centralized bulk procurement will enter a critical period of consolidation and enhancement. The focus of the policy will shift from "expanding coverage and reducing prices" to "stabilizing prices and improving quality." By dynamically adjusting the selection rules, it ensures that price reductions do not compromise quality, promoting the industry towards standardization and sustainable development.First, the volume-based procurement continues to advance, with procurement scope expanding nationwide. By 2025, seven categories and ten types of medical consumables, including ultrasonic scalpel heads, ligation clips, neurointerventional coils, breast biopsy needles, orthopedic trauma products, dental implants, bone cement for joints, coronary expansion balloons, coronary drug balloons, and coronary intravascular ultrasound diagnostic catheters, have achieved 100% coverage across all regions in China through provincial alliances and provincial volume-based procurement.Dual-chamber pacemakers, coronary guiding catheters, coronary guidewires, manual laparoscopic cutting/stapling devices and staple cartridges, atrial septal puncture sheaths, electrophysiology catheter sheaths, atrial septal puncture needles, surface positioning reference electrodes, perfusion tubing, electrical positioning diagnostic catheters, magnetic positioning diagnostic catheters, intracardiac ultrasound catheters, electrical positioning therapy catheters, magnetic positioning therapy catheters, cryoablation therapy catheters, and electric laparoscopic cutting/stapling devices and staple cartridges have achieved over 90% regional coverage.The municipal centralized procurement will expand the "supplement" scope, extending to county-level medical communities, focusing on basic consumables and low-value medical materials. New forms of centralized procurement, such as "package procurement" for reagents and equipment, as well as the procurement of new products like AI-assisted consumables, will gradually enter the scope of centralized procurement.Secondly, the optimization and improvement of the "one product, one policy" approach have led to more precise centralized procurement rules. In response to the characteristics of different product categories, the rules for centralized procurement have become more refined. For example, in the centralized procurement of cochlear implants, a technical bonus for "3.0T MRI compatibility" has been introduced to encourage technological upgrades among companies. Peripheral vascular stents are grouped and bid on according to treatment location (lower limb/non-lower limb/venous), balancing clinical needs with market competition. This differentiated strategy effectively balances market competition with industry innovation, avoiding the supply risks associated with a "one-size-fits-all" approach.Third, national joint procurement and regional collaboration to break down regional barriers. Provincial alliances are accelerating their evolution into nationwide procurement initiatives. By 2025, the provincial alliance led by Zhejiang and Fujian had achieved nationwide procurement, covering 32 provincial-level administrative regions. In the future, under policy guidance, such projects will become more prevalent. National joint procurement, through unified rules and collaborative negotiations, reduces administrative costs, avoids local protectionism, and promotes the formation of a "unified national market" landscape.Fourth, deepening price management, implementing dynamic regulation and reasonable price differentials in parallel. We will enhance the price linkage mechanism and conduct regular monitoring of centralized procurement varieties. The National Healthcare Security Administration requires all provinces to continue squeezing out the inflated prices of overpriced products and dynamically adjust the selected prices for those with unstable supply or rising costs. At the same time, a price differential regulation mechanism within and between enterprises will be established. For instance, in the follow-up procurement of artificial joints, the price difference of selected products has been reduced from 2.8 times to 1.1 times, promoting fair market competition. Additionally, the listed price of non-selected products must not exceed 1.5 times the selected price, and non-compliant products will be suspended from procurement.Fifth, a dual-wheel drive of credit management and surplus retention policies ensures the implementation of centralized procurement. The credit evaluation system and medical insurance surplus retention policy have become the core tools for the execution of centralized procurement. The former implements graded punishment on enterprises with unstable supply and substandard quality, while the latter establishes an incentive mechanism of "retention of savings and sharing of excesses," returning the saved medical insurance funds to healthcare institutions. By incorporating the execution rate of centralized procurement by healthcare institutions into performance evaluations, it incentivizes the priority use of selected products, ensuring the implementation of the procurement results.Sixth, the process of domestic substitution is accelerating, and technological breakthroughs are reshaping the market landscape. In the five batches of national centralized procurement of high-value medical consumables, the market share of domestic products has continued to rise. For example, the localization rate of coronary stents increased from 70% in the first volume-based procurement in 2020 to 80% in the subsequent procurement in 2022; orthopedic artificial joints also rose from 52% in the first volume-based procurement to 67% in the subsequent procurement. According to incomplete statistics, the current localization rates are 70% for orthopedic spinal consumables, 60% for intraocular lenses, 45% for orthopedic sports medicine products, and 30% for cochlear implants.Seventh, implement standardized closed-loop management throughout the entire process from procurement, usage to settlement. Strengthen supervision over the entry, distribution, and use of centrally procured products in medical institutions. The National Healthcare Security Administration requires medical institutions to procure through provincial platforms, upload inventory and flow data in real time, and establish a quality traceability system. At the same time, the online procurement rate of high-value consumables will be included in the scope of the healthcare security inspections. Institutions that fail to meet the agreed procurement volume or exhibit abnormal use of high-priced non-selected products will be summoned for discussions. The direct settlement between the healthcare security fund and enterprises will be promoted to shorten the payment cycle to within 30 days.Eighth, the separation of technology and consumables should be promoted in coordination with the reform of medical service prices. The year 2025 is a significant year for the reform of medical service prices. Currently, 24 project guidelines have been issued, and provinces are required to complete price adjustments by the third quarter of this year, aiming to establish a unified national price within 2 to 3 years. The National Healthcare Security Administration has made it clear that surgical treatment projects closely related to the centralized procurement of consumables will be prioritized for price adjustments. The reform of medical service prices and centralized procurement should work together to reduce the proportion of consumables through the principle of "separation of technology and consumables," guiding medical institutions to reduce their excessive reliance on high-value consumables and enhance the value of technical services.Ninth, the centralized procurement of medical consumables is transitioning from "price discovery" to "value-based procurement." By 2025, this transition in China’s medical consumables centralized procurement has entered a critical phase, requiring a dynamic balance between "basic coverage" and "innovation promotion." Through innovations in rules, improvements in mechanisms, and technological empowerment, the industry needs to shift from "price competition" to "value competition." As living standards improve and medical technology advances, both patients and healthcare institutions demand more than just low-priced consumables; they place greater emphasis on quality, performance, and applicability. Value-based procurement can better meet the diverse and multi-tiered demands of the medical field, aligning with the development trends of the medical industry.With the continuous advancement of big data and artificial intelligence technologies in the medical field, more data and technical tools will be utilized for the value assessment of medical consumables in the future. This will provide stronger support for value-based procurement and drive its ongoing refinement and development.

The General Office of the National Medical Products Administration has issued the "Measures for Optimizing the Full Life Cycle Regulation to Support the Development of High-End Medical Devices (Draft for Soliciting Opinions)" for public consultation. The draft proposes to strengthen standard leadership innovation and further improve the standard system for high-end medical devices. It accelerates the release of related standards such as medical exoskeleton robots and radionuclide imaging equipment. It also expedites the formulation and revision of foundational, universal standards and method standards in areas like medical robots, artificial intelligence medical devices, and high-end medical imaging equipment, actively establishing technical committees for medical robots and artificial intelligence medical devices. It strengthens the standardization research on new biomaterials such as additively manufactured medical materials, flexible electrodes for brain-computer interfaces, and gene-engineered synthetic biomaterials. It conducts studies on digital standard sample datasets for artificial intelligence medical devices. Based on the development of the industry and regulatory needs, it promotes the initiation of urgently needed standards for high-end medical devices through fast-track procedures.Measures by the National Medical Products Administration to optimize the whole lifecycle regulation and support the innovative development of high-end medical devices. (Draft for Comments)Medical robots, high-end medical imaging equipment, AI-powered medical devices, and new biomaterial medical devices (hereinafter referred to as high-end medical devices) are key areas in shaping the new quality productive forces of the medical device industry. To thoroughly implement the spirit of the Third Plenary Session of the 20th CPC Central Committee, fulfill the requirements of the *State Council's Notice on Comprehensively Deepening Reforms in Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry* (State Council Document [2024] No. 53), improve the review and approval mechanisms, strengthen full lifecycle supervision, fully support major innovations in high-end medical devices, and promote the application of more new technologies, materials, processes, and methods in the healthcare sector to better meet public health needs, the National Medical Products Administration has proposed the following supportive measures.Optimize Special Approval ProceduresHigh-end medical devices that meet the criteria of being domestically pioneering, internationally leading, and having significant clinical application value will continue to undergo special innovation examination. The standards for such examinations will be further clarified, and the expert review mechanism optimized. For changes in registration for high-end innovative medical devices, reviews will be conducted according to the special innovation examination procedures. Support will be provided for the expedited market entry of high-end medical devices mentioned in national-level high-quality development action plans and other industrial policies. Registration guidance will be strengthened for AI and biomaterial products selected through the "call for proposals" system, and cooperation with relevant departments will be enhanced to develop support policies for medical devices based on brain-computer interface technology. For high-end medical devices approved under conditional approval, specific requirements for such approvals will be explored.II. Improve classification and naming rulesStrengthen guidance on product classification and naming for relevant products to support the registration and application of high-end medical devices. Develop classification guidelines for medical robots such as surgical robots and rehabilitation robots, and form an expert consensus on the naming of medical robots. Conduct research on the management attributes and categories of new functional, technological, and modal products such as medical large models, artificial intelligence medical devices, synthetic biomaterial tissue engineering products, and medical imaging reconstruction software. Dynamically adjust product management categories based on the maturity of technological development. Refine management requirements for core components of medical robots and high-end medical imaging equipment.3. Continuously improve the standard systemStrengthen innovation through standard leadership and further improve the high-end medical device standard system. Accelerate the release of standards related to medical exoskeleton robots and radionuclide imaging equipment. Expedite the formulation and revision of basic, general, and methodological standards in areas such as medical robots, AI medical devices, and high-end medical imaging equipment, and actively establish standardization technical committees for medical robots and AI medical devices. Enhance standardization research on new biomaterials such as medical materials for additive manufacturing, flexible electrodes for brain-computer interfaces, and genetically engineered synthetic biomaterials. Conduct research on digital standard sample datasets for AI medical devices. Based on industry development and regulatory needs, promote the urgent standardization of high-end medical devices through fast-track procedures.IV. Further Clarify the Requirements for Registration ReviewScientifically formulate the evaluation requirements for high-end medical devices and improve the registration and review system for high-end medical devices. Accelerate the formulation and revision of technical review guidelines for related products such as laparoscopic surgical systems, medical magnetic resonance imaging systems, oral bone filling materials for implants, and nickel-titanium alloy intravascular implants. Develop technical guidelines or review points for the multi-disease and large-model artificial intelligence fields; simplify the change registration requirements for AI medical device products with unchanged core algorithms but optimized algorithm performance; explore and improve the requirements for performance evaluation of AI medical devices using test databases; for the same AI software function registered on different platforms, if platform equivalence can be proven, simplify the review requirements. Study the application of AI and biochip technologies in the performance and safety evaluation of biomaterial medical devices. Revise the technical review guidelines for the registration of high-end active medical devices' service life. Explore the pathways and requirements for high-end medical devices to use electronic instructions.Five, improve the communication guidance mechanism and expert consultation mechanismStrengthen service guidance and communication exchanges for high-end medical device product testing, clinical evaluation, and registration application documentation. Shift the focus of the review process to earlier stages of high-end medical device product development, and enhance preliminary review work. Further enrich the expert database for reviewing high-end medical devices by increasing the number of experts in research, engineering, clinical practices, and other relevant fields, and establish a High-End Medical Device Expert Advisory Committee. Build a long-term mechanism for expert intellectual support to propose suggestions and measures for supporting high-end medical devices at the forefront of technological development. Explore a mechanism to move the pre-inspection work for the registration system of innovative high-end medical devices forward, promoting earlier inspection points and phased inspection models to help companies identify and improve system deficiencies in a timely manner.Six, refine post-listing regulatory requirements.Select domestically pioneering and other representative innovative medical devices to carry out regulatory consultations, guide provinces with a concentration of innovative medical devices to conduct local regulatory consultations, analyze innovation points and risk points, and study targeted regulatory measures. Accelerate the formulation of inspection key points for the quality management systems of innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufactured bone implants, polyetheretherketone suture anchors, as well as high-end products like medical surgical robots, artificial intelligence medical devices, and recombinant collagen. Strengthen the selection and training of national-level inspectors, cultivate a group of high-end medical device national-level inspectors; carry out verification of the quality management systems of provincial inspection institutions, enhance the capacity building of provincial inspection institutions, and improve the quality and efficiency of inspections.Strengthen post-listing quality monitoring.Research on the management requirements for the service life of high-end active medical devices in use. Urge medical device users to conduct regular inspections and maintenance of surgical robots, rehabilitation robots, and high-end medical imaging equipment to ensure clinical quality. Support medical device registrants in conducting post-market evidence-based studies. Refine the types of adverse events for high-end medical imaging equipment and AI medical devices, and develop corresponding reporting scope standards to improve the quality of adverse event reports. Continue to promote the Global Harmonization Working Party (GHWP) in initiating new active monitoring projects, using high-risk cardiovascular implantable medical devices as a starting point to explore the development of a scalable basic framework for post-market active monitoring of medical devices. Guide registrants to utilize new tools and methods in medical device vigilance for signal detection and utilization of adverse event monitoring data. Encourage companies to proactively conduct post-market evaluations to continuously enhance product safety and reliability. Guide local authorities in strengthening the development of inspection and vigilance teams for innovative medical devices, improving the inspection and monitoring capabilities for such devices.8. Closely follow up on industrial developmentRegularly publish the list of approved high-end medical device products to the public. Establish a research working group for the development of the high-end medical device industry, organize the compilation of an annual report on scientific regulation and industrial development of high-end medical devices, study and release information on industry status and trends, and propose measures to promote high-quality industrial development. Fully leverage the expert resources of industry associations and academic institutions, establish a regular communication mechanism, promptly collect, organize, summarize, and analyze the development trends of high-end medical devices, identify issues encountered in development, and provide regulatory recommendations.IX. Advancing Regulatory Science ResearchGive full play to the roles of the Artificial Intelligence Medical Device Innovation Cooperation Platform, Biomaterials Innovation Cooperation Platform, and High-End Medical Equipment Innovation Cooperation Platform, actively track cutting-edge advancements and scientific developments in high-end medical devices, and accelerate the development of new tools, standards, and methods. Advance key projects in regulatory science systems, such as research on the performance and safety evaluation of innovative biomaterial-based medical devices and systematic evaluation methods for the safety and efficacy of medical devices based on brain-computer interface technology. Proactively plan research projects in regulatory science for high-end medical devices to strengthen technical regulatory preparedness. Continue to conduct real-world studies on high-end medical devices and promote the use of real-world evidence in regulatory decision-making.Tenth, promote global regulatory coordinationActively participate in the formulation of international standards, accelerate the application of international standard conversions, and strengthen training on domestic regulatory standards. Engage proactively in international regulatory organizations such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP), as well as international exchanges and cooperation with drug regulatory agencies in Belt and Road countries and regions. Support high-end medical device companies in expanding overseas, refine policies related to medical device export sales certificates, and broaden the scope of issuance for such certificates. Leverage international exchange platforms to promptly identify new opportunities in innovative international medical device products, and actively promote China’s medical device regulatory model and innovation achievements.

【2025W14-Vol.51】The Trump administration plans to cut tens of thousands of employees from the Department of Health and Human Services.On March 27, Robert F. Kennedy, the newly appointed U.S. Secretary of Health and Human Services (HHS), announced that the Trump administration plans to cut 10,000 full-time positions within HHS and its subordinate agencies. This layoff initiative is part of a broader federal workforce reduction plan led by the "Department of Government Efficiency" (DOGE), which is headed by Elon Musk.The institutions facing layoffs include the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare Medicaid Services (CMS). Among them, FDA will cut 3,500 employees, approximately 19% of its total workforce; CDC will cut 2,400 employees, accounting for 18%; NIH will cut 1,200 employees, accounting for 6%; CMS will cut 300 employees, accounting for 4%.In addition, the HHS also plans to merge the department's 28 bureaus into 15 and reduce its 10 regional offices to 5.2. FDA Approves First Automated Endoscope Cleaning SystemOn March 20, the U.S. FDA officially approved the first automated endoscope cleaning system using Nanosonics CORIS technology. Developed by the Australian medical technology company Nanosonics, the system focuses on deep cleaning of the complex internal channels of flexible endoscopes such as gastroscopes and colonoscopes.Traditional manual cleaning methods have difficulty reaching the narrow, complex internal channels, often leading to the accumulation of biofilm residues, which increases the risk of hospital-acquired infections. The CORIS system utilizes a unique automated cleaning mechanism that can penetrate the narrowest parts of endoscopes, effectively removing tough biofilms.The FDA has previously urged the use of disposable components or systems to reduce infection risks, but disposable systems are costly and have many limitations. The emergence of the CORIS system provides medical institutions with an economical and efficient solution.3. Bausch + Lomb recalls some intraocular lens productsOn March 27, Bausch + Lomb announced a voluntary recall of certain intraocular lenses from the enVista platform, including enVista Aspire, enVista Envy, and certain enVista monofocal lenses.This recall is due to an unexplained increase in cases of toxic anterior segment syndrome following the implantation of these lenses. This condition is an inflammatory reaction in the eye that can occur 12 to 48 hours after cataract surgery, caused by various factors including bacterial contamination or toxic substances during the procedure.Supira Medical Completes $120 Million Series E Financing to Advance Clinical ProgramsOn March 26, vascular interventional developer and manufacturer Supira Medical announced the successful completion of an oversubscribed Series E financing round, raising a total of $120 million. The funds will be used to advance clinical programs for the next-generation percutaneous ventricular assist device (pVAD) in high-risk percutaneous coronary interventions and cardiogenic shock, including supporting the U.S. pivotal SUPPORT II study for FDA premarket approval (PMA).The company has recently completed the enrollment for the U.S. SUPPORT I Early Feasibility Study (EFS), recruiting a total of 15 patients across four clinical centers to evaluate the safety and feasibility of the company's innovative pVAD in high-risk coronary intervention patients.5. The U.S. Senate confirms the appointment of a new FDA commissioner.On March 26th, the U.S. Senate confirmed Dr. Martin Makary as the Commissioner of the U.S. Food and Drug Administration (FDA) with a vote of 56-44.Dr. Makary is a surgical oncologist and gastrointestinal laparoscopic surgeon at Johns Hopkins Hospital, who has long advocated for innovative technologies in the medical device industry. He has also drawn attention for his skepticism toward public health measures during the pandemic, as while he supports vaccination, he holds reservations about childhood vaccinations and long-term lockdown measures.Dr. Makari stated at the confirmation hearing that he believes in the importance of collaborating with the medical device and pharmaceutical industries, advocating for more independent scientific reviews to promote more localized treatment solutions. He also mentioned that he hopes to put more medical technologies into the hands of consumers, such as promoting over-the-counter drugs and continuous glucose monitoring devices.Medtronic's Affera ablation mapping system makes its first clinical application in SwedenOn March 26, Medtronic announced that the Affera Mapping and Ablation System was introduced into clinical practice for the first time in Sweden. The system includes the Sphere-9 catheter and the Affera Prism-1 mapping software, designed to provide real-time feedback through intuitive mapping and navigation software, thereby more effectively treating arrhythmias such as atrial fibrillation (AFib).The system received FDA approval in October 2024, making Medtronic the only company with two pulse field ablation technologies for atrial fibrillation. Medtronic plans to expand the system to more Nordic countries.Solventum and SprintRay Form Strategic Partnership to Advance Dental 3D Printing TechnologyOn March 26, Solventum announced a strategic partnership with SprintRay, aiming to provide innovative solutions for dental clinics through 3D printing technology.This collaboration will focus on the development and commercialization of high-quality, durable, and permanent same-day repair solutions, including dental crowns, inlays, and veneers. The goal of the partnership is to launch the first permanent chairside 3D printed dental crown on the market.Solventum has several products that are widely used in dental restorations. SprintRay, on the other hand, is renowned for its innovative chairside 3D printing ecosystem, capable of providing a one-stop solution for dental restorations.Evident Vascular Completes Series B Financing to Advance AI-Driven Intravascular Ultrasound PlatformOn March 25, Evident Vascular announced the completion of its Series B financing. Although the company did not disclose the specific amount of the financing, the funds will be used to accelerate the development of its AI-driven intravascular ultrasound (IVUS) platform to obtain FDA approval and prepare for launch in the U.S. market.Evident Vascular's next-generation IVUS platform combines artificial intelligence technology to optimize vascular imaging for peripheral and coronary interventional treatments. The company plans to expand the clinical applications of IVUS through innovation, enhancing its practicality and accessibility.Terryford announced that the UroLift system for prostate elevation is superior to the Rezūm water vapor therapy.From March 21 to 24, at the 40th European Association of Urology Congress held in Madrid, Teleflex (NYSE: TFX) announced new data from the CLEAR study, showing that the UroLift System outperformed the Rezūm therapy in the clinical treatment of benign prostatic hyperplasia.This study is the first head-to-head randomized controlled trial (RCT) comparing the UroLift Prostatic Urethral Lift System (PUL) and Rezūm Water Vapor Thermal Therapy (WVTT) for the treatment of benign prostatic hyperplasia (BPH). The results show that the UroLift system performs better in early patient satisfaction and sexual function.Abbott's IVL System Receives FDA IDE Approval to Initiate Clinical TrialsOn March 24, Abbott announced that the Coronary Intravascular Lithotripsy (IVL) System had received a Investigational Device Exemption (IDE) approval from the U.S. FDA. The system is designed to treat severe calcification in coronary arteries using high-energy acoustic pressure waves, preparing the way for subsequent stent implantation. Abbott plans to conduct a clinical trial called TECTONIC, which will recruit up to 335 participants at 47 sites across the United States.11. Newronika's AlphaDBS system receives CE approval for Parkinson's treatment.On March 24, neurotechnology company Newronika announced that its AlphaDBS device has received CE mark approval for the treatment of Parkinson's disease.AlphaDBS is a next-generation closed-loop deep brain stimulation (DBS) system capable of dynamically adjusting stimulation based on real-time brain signals. The system optimizes symptom control, reduces side effects, and minimizes the need for frequent programming adjustments by neurologists by monitoring the patient's brain activity.Newronika plans to launch the system in certain European markets by 2025 and has obtained the FDA Investigational Device Exemption (IDE) to initiate a pivotal clinical trial.12. Imperative Care's Symphony 16 Fr 82cm Catheter Receives FDA Approval for Venous Thrombosis TreatmentOn March 24, Imperative Care announced that the Symphony 16Fr 82cm catheter received 510(k) clearance from the U.S. FDA for the treatment of venous thrombosis.The catheter is part of the Symphony Thrombectomy System, which also includes 16Fr 117cm and 24Fr 85cm catheters. The system achieves efficient thrombus removal through a large-bore suction catheter and powerful deep vacuum technology, while minimizing blood loss.Additionally, Inari Medical filed a patent infringement lawsuit in May 2024 against Imperative Care and its subsidiary Truvic Medical, alleging that their Symphony thrombectomy system infringed on Inari's patents. Imperative Care denied the infringement claims and filed a counterclaim. The lawsuit is still ongoing.

The low-value consumables alliance procurement is back.01Sutures and five other types of consumables will be included in the alliance procurement.According to Huazhao Medical Device Network, on March 28, the Liaoning Provincial Medical Insurance Platform issued a notice titled "Notice on Carrying Out Information Maintenance Work for Concentrated Bulk Purchase Products of Five Categories of Medical Consumables such as Interprovincial Alliance Sutures." It shows that in order to properly conduct the concentrated bulk purchasing of medical consumables such as interprovincial alliance sutures, information maintenance for the proposed bulk purchase products is now being carried out.The product range includes: sutures, syringes (with needles), infusion sets for pumps, vacuum blood collection tubes (including venous blood collection needles), and oxygen supply tubes.In terms of inter-provincial alliance centralized procurement, there were also some projects last year focusing on low-value consumables. The overall bargaining power was strong, with larger-scale projects including the pre-filled catheter flushing device centralized procurement led by Inner Mongolia (average reduction of 85.4%) and the centralized procurement of six categories of needle-free connectors and other consumables led by Liaoning (average reduction of 77%).Liaoning has accumulated certain experience in leading the alliance procurement of low-value consumables. The official documents for the new round of procurement have not yet been released, and relevant companies can further pay attention during the subsequent solicitation of opinions.Since the beginning of the year, there has been a concentrated effort in the collection of low-value consumables. According to the analysis by Saibolan Medical Devices, as of now, several regions including Hunan, Jiangxi, Hebei, Jiangsu, Liaoning, and Fujian have advanced the collection of low-value consumables.Hebei and Jiangsu are conducting follow-up procurement. The collection of 17 types of consumables such as infusion ports in Hebei and 7 types of consumables including blood glucose test strips led by Sanming has recently announced the proposed winning results. The Sanming-led collection mainly focuses on low-value consumables, with an average price drop of 70.62% in the previous round, and a maximum drop of 93.02%. Jiangsu's vacuum blood collection tubes will also conduct follow-up procurement, with an average price drop of 37% in the previous collection.02"Under the 'Hurricane' of Centralized Procurement"According to different clinical uses, low-value medical consumables can be divided into categories such as medical sanitary materials and dressings, injection and puncture materials, medical polymer materials, medical disinfectants, anesthesia consumables, operating room consumables, and medical technology consumables. Data from the "China Medical Device Blue Book (2021 Edition)" predicts that by 2025, the domestic market scale of low-value medical consumables will reach 220 billion yuan.In the hundred billion market, the disruptive impact of centralized procurement "hurricane" has become increasingly evident. Overall, while centralized procurement of consumables has mainly focused on high-value consumables, widely used low-value consumables have also attracted significant attention. Years of price suppression have intensified competition in this red ocean market.In the era of centralized procurement, the Matthew Effect is more pronounced. For general consumption manufacturers, the importance of "cost control" is highlighted. Leading enterprises, based on their larger production and sales scale, can effectively enhance their cost competitiveness by relying on advantages in the industrial chain and cross-regional layout.Kangdelai, which specializes in medical puncture needles and infusion devices, pointed out in its financial report that in the intense competitive environment driven by centralized procurement policies, product cost has become a crucial factor for market competitiveness in the medical device industry.Under centralized procurement, companies are also changing their business strategies.Kang Delai pointed out that centralized procurement encourages distributors to transform into distribution and service providers. The company has established regional channels and distribution service agencies in East China, South China, North China, Central China, Southwest, and Northwest through resource integration and investment mergers and acquisitions. It has also increased the expansion of SPD distribution services to hospital terminals, formed specialized product marketing service teams, and promoted the marketing model of "agent distribution + distribution + third-party supply chain services." At the same time, taking centralized procurement bidding as an opportunity, the company is expanding into untapped markets, exploring the marginal benefits of products after winning centralized procurement bids, and extending more products through new centralized procurement channels to terminal hospitals in various regions.Jianerkang, which primarily produces medical dressings, stated that it will further strengthen its product layout in the high-end medical dressing sector and increase investment in research and technological innovation. Currently, the medical dressing industry is continuously transitioning and upgrading towards high-end production. From a global perspective, there is a noticeable increase in demand from downstream markets for multifunctional, new material, and high value-added medical dressings. However, the production and manufacturing technology of medical dressing products in China still lags behind that of developed countries, with products mainly consisting of traditional medical dressings and sanitary textiles.Overall, the exploration of the high-end market is imperative, and innovation will continue to bring significant growth opportunities.

01Regulatory DynamicsThe National Medical Device Sampling Inspection Work Promotion Meeting for 2025 was held. On March 26, the official website of the National Medical Products Administration announced that a meeting to promote the national medical device sampling inspection work was held in Chengdu. The meeting summarized the achievements of the sampling inspection work in 2024, conducted an in-depth analysis of the current situation, and researched and deployed the key tasks for sampling inspection in 2025.The meeting noted that at all levels, the drug regulatory authorities and medical device inspection institutions have earnestly implemented the "four strictest" requirements, closely following the work思路of "upholding political integrity, strengthening regulation, ensuring safety, promoting development, and benefiting people's livelihoods." They successfully completed the 2024 national supervision and sampling tasks, which have promoted improvements in product quality and effectively safeguarded the public's safe use of medical devices.2. Disposable pressure-sensing radiofrequency ablation catheter innovative product approved for NMPA market launchOn March 26, the National Medical Products Administration approved the registration application for the innovative product of Hunan Aipute Medical Device Co., Ltd.'s disposable pressure monitoring radiofrequency ablation catheter.The single-use pressure monitoring radiofrequency ablation catheter enables real-time pressure monitoring and feedback during clinical use through a built-in optical pressure sensor, ensuring the stability of the ablation effect. This product can effectively reduce the risks of steam pop caused by excessive contact between the catheter and tissue during the procedure or incomplete ablation due to insufficient contact, benefiting more patients with paroxysmal atrial fibrillation.3. Broncus Medical: Lung Imaging Processing Software Approved for Market Launch in ChinaOn March 21, Broncus Medical announced that its lung imaging processing software, BroncQCT, has been officially approved by the Zhejiang Provincial Medical Products Administration for launch in China.The approval of this software for marketing reflects Broncus Medical's commitment to developing solutions that enhance clinical benefits, further solidifying the company's position in the field of precise interventional diagnosis and treatment of pulmonary diseases. It is expected that this software will improve doctors' efficiency in reading pulmonary CT images, provide strong support for clinical auxiliary diagnosis and treatment, and promote a more efficient and accurate diagnostic process. 02Capital MarketWanhai Medical Completes 100 Million Yuan FinancingRecently, Jiangsu Wanhai Medical Devices Co., Ltd. announced the completion of financing amounting to one billion yuan, with this round exclusively invested by IDG Capital.This financing will help Wanhai Medical further expand its annual production capacity from the existing 90 million units to 310 million units, forming a total production capacity of 400 million units at an automated and intelligent injection pen production base, further consolidating its leadership position in the global injection pen market.Wanhai Medical, founded in 2016, is headquartered in Xitaihu, Changzhou, Jiangsu, with a branch in Shanghai. It is a national high-tech enterprise and a specialized and innovative company. The company focuses on the research, development, production, and sales of various injection pen products.Cheng Tian Technology Completes Series B Financing of Nearly 100 Million YuanThis week, Hangzhou Chengtian Technology Development Co., Ltd. announced the completion of nearly 100 million yuan in Series B financing. This round of financing was led by Xichuang Investment. The funds will be primarily used for the research and development iteration of embodied intelligent exoskeleton technology, the development and registration of new brain-machine products, the expansion of production bases, and global market expansion, further promoting the application of embodied intelligent exoskeleton wearable robots in rehabilitation, elderly care, and consumer markets, accelerating the expansion of domestic and international channel networks, and building a globally leading exoskeleton technology enterprise.3. Sanxin Medical's net profit increased by 10.05% year-on-year in 2024.On March 26, Sanxin Medical disclosed its annual report, showing that the company achieved operating revenue of 1.5 billion yuan in 2024, increasing by 15.41% year-on-year; net profit was 227 million yuan, increasing by 10.05% year-on-year; basic earnings per share was 0.44 yuan. The company plans to distribute a cash dividend of 2 yuan per 10 shares (including tax). During the reporting period, the blood purification products achieved operating revenue of 1.217 billion yuan, increasing by 28.20% over the same period last year. The operating revenue of such products accounted for 81.11% of the company's total revenue.Wandong Medical's operating revenue increased by 23.26% year-on-year in 2024.On March 21, Wandong Medical disclosed its 2024 financial report, showing that the company achieved operating revenue of 1.524 billion yuan during the reporting period, a year-on-year increase of 23.26%; the non-GAAP net profit attributable to the parent company was 142 million yuan, a year-on-year increase of 4.84%.Amplex Corporation's net profit for the year 2024 is 1.958 billion yuan. (Note: The company name "爱美客" is translated as "Amplex Corporation" assuming it refers to a fictional or general cosmetic company based on the context. If this is a specific company, please provide the correct English name for an accurate translation.)On the evening of March 19, Aimeike announced its annual report for 2024. In 2024, the company achieved operating revenue of 3.026 billion yuan, a year-on-year increase of 5.45%; the net profit attributable to shareholders of the listed company was 1.958 billion yuan, a year-on-year increase of 5.33%; the net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses was 1.872 billion yuan, a year-on-year increase of 2.2%.6. Innovation Medical's major shareholders, directors, and executives all announced share reduction plans.On March 24, Innovative Medical issued a share reduction announcement, stating that the company recently received the "Notice of Share Reduction Plan." Shareholders Shanghai Guanghuan, Director Ruan Guangyin, and Acting CFO Ma Jianjian respectively submitted their reduction plans.Holding 3,160,200 shares of the company, accounting for 0.7161% of the company's total share capital, plans to reduce the company's shares by centralized bidding within three months after 15 trading days from the date of this announcement. The reduction quantity will not exceed 790,000 shares, which is no more than 0.1791% of the company's total share capital. 03Corporate News1. Sinopharm Group establishes new medical companyOn March 24, information on the AiQicha website showed that Huiyikang Medical Health Technology (Shanghai) Co., Ltd. was established, with Chen Tao as the legal representative. The company has a registered capital of 20 million RMB and is wholly owned by Yukang Hongbo Medical (Xiamen) Co., Ltd.The business scope includes: health consulting services (excluding medical treatment services); remote health management services; medical research and experimental development; sales and leasing of Class I medical devices; sales of household appliances; sales of personal hygiene products; sales of hygiene products and disposable medical supplies; sales and leasing of Class II medical devices, etc. The investor, Yuhong Hongbo Medical, is a subsidiary of China National Pharmaceutical Group Corporation.2. Hengrui Medical AI Full-Automatic Injection Pen Production Line Mass ProductionThis week, Suzhou Precision Medical Technology Co., Ltd., a subsidiary of Suzhou Hengrui Medical Devices Co., Ltd., announced the official commencement of mass production on its first AI fully automated injection pen production line, with an annual capacity of 20 million units. Additionally, the company has established strategic partnerships with several industry leaders, including Zhitai Biotech, WuXi Biologics, and Porton Biologics.This milestone event marks that while breaking through patent barriers and achieving independent original research, China's domestically produced automatic injection pen has made key progress in the field of intelligent manufacturing of new drug delivery devices.

In order to standardize the management of medical consumables payment under medical insurance and improve the efficiency of fund utilization, the Shandong Provincial Medical Security Bureau has recently officially issued the "Interim Measures for the Payment Management of Medical Consumables under Basic Medical Insurance in Shandong Province." The aim is to establish a unified medical insurance consumables catalog across the province, clarify payment standards, and optimize clinical usage management.This report will revolve around the core content of the policy, material access conditions, payment ratios, dynamic adjustment mechanisms, and the implementation details in coordinating regions, providing policy interpretations and implementation references for relevant institutions and insured individuals.01Policy Background and ObjectivesRecently, the Shandong Provincial Medical Security Bureau issued the "Interim Measures for the Payment Management of Medical Consumables under the Basic Medical Insurance in Shandong Province" [1] (hereinafter referred to as the "Measures"), aiming to regulate the access management of medical consumables for medical insurance payments, improve the level of medical security, and optimize the efficiency of medical insurance fund utilization. The policy will be implemented from February 1, 2025, and will remain valid until January 31, 2028.The core objectives of this policy reportedly include:1. Unify the provincial medical consumables directory: Address the significant differences in医保支付范围 (medical insurance payment scope) among different coordinated regions, and establish a unified "Basic Medical Insurance Medical Consumables Directory" province-wide. (Note: There was a part missing in the original Chinese text which said "解决此前各统筹区医保支付范围差异较大的问题". I have provided a suitable translation for it.)Balancing clinical needs with fund affordability: Through scientific evaluation and dynamic adjustment mechanisms, comprehensively consider factors such as the functionality of medical consumables, clinical value, correspondence with medical service price items, cost levels, and the affordability of medical insurance funds, ensuring that the consumables included in the directory meet the requirements of being "clinically necessary, safe and effective, and reasonably priced."3. Medical consumables selected through centralized volume-based procurement, which comply with current payment policies, will be prioritized for inclusion in the catalog. Exploration of access for exclusive or high-value products through negotiation or other methods will be conducted.02Medical Consumables Directory Management Mechanism(1) Admission CriteriaMedical consumables must meet the following conditions to be included in the "Basic Medical Insurance Medical Consumables Directory":1. Compliance: Registered or filed with the drug regulatory authority and within the validity period.2. Separate charges: Disposable materials that are not included in the pricing structure of medical service projects and can be charged separately.3. Clinical and Economic Considerations: Clinically essential, safe and effective, reasonably priced, and affordable for the medical insurance fund.4. Unified coding: Obtain the unified code for medical consumables from the National Medical Security Administration.(II) Clearly define the scope of exclusionThe following circumstances are not covered by medical insurance payments:1. Non-therapeutic devices: Such as prosthetic teeth, prosthetic eyes, prosthetic limbs, hearing aids, and other rehabilitation devices.2. Beauty and healthcare consumables: including non-functional cosmetic and orthopedic-related consumables.3. Low-value or overburdened consumables: Items with low clinical value or costs exceeding the capacity of the medical insurance fund.03Payment Standards and Personal BurdenThe individual initial self-payment ratio, reimbursement ratio, and specific payment methods for medical consumables shall be implemented by each coordinating region in accordance with relevant national, provincial, and regional regulations. Each coordinating region must comprehensively consider various factors, such as the cost of medical consumables, the local medical standards, economic development level, the supporting capacity of the medical insurance fund, and the patients' affordability, to reasonably establish the medical insurance payment cap for medical consumables within the region.1. Classification of payment ratios:High-value consumables with a unit price exceeding 1,000 yuan require an initial self-payment of 15% by the individual; consumables with a unit price below 1,000 yuan do not require self-payment.In the centralized volume-based procurement of selected medical consumables, the individual co-payment ratio is 0%.2. Payment Limit Mechanism:Each coordinating region sets payment limits based on local economic levels and the fund's affordability. If the cost of medical consumables exceeds the limit, the excess portion is borne by the insured person; if it is below the limit, reimbursement is made proportionally.04Dynamic adjustment and execution mechanism1. Dynamic Adjustment Program:The directory is managed dynamically. Medical institutions can apply through a process involving submission by the medical institution, preliminary review at the municipal level, and expert review at the provincial level. After filing with the national bureau, it can be published and implemented, and dynamically adjusted.Priority will be given to including selected products in centralized volume-based procurement, and exploring negotiated access for high-value medical consumables.2. Transfer Mechanism:If there are safety risks associated with the consumables, cancellation of registration qualifications, or violations in entering the directory, they will be directly removed after evaluation.05Policy Implementation Requirements and Impact1. Responsibility of medical institutionsDesignated medical institutions must prioritize the use of listed medical supplies and products selected in centralized procurement. Violations such as duplicate charges for low-value consumables will be penalized.2. Information Management:Leveraging the national medical insurance coding system, unify the classification and payment standards of consumables to ensure transparency in the implementation of the directory.Social Supervision and Transparency:Provincial medical insurance departments regularly publish directories and inquiry channels, and each coordinated area needs to strengthen fund usage monitoring and expense review.06Policy Significance and OutlookShandong Province has balanced clinical needs with the sustainability of the fund through a unified medical consumables directory and dynamic adjustment mechanism. At the same time, it has reduced the burden on patients through priority procurement and payment limits. In the future, policies may further promote price transparency of consumables and cover more innovative products through negotiation mechanisms, thereby improving the efficiency of medical insurance fund utilization.

Recently, a survey initiated by the Biotechnology Innovation Organization (BIO) shows that the tariffs threatened by the Trump administration against Europe could have a significant impact on the biotechnology industry.According to survey data,94% of the surveyed companies stated that imposing tariffs on EU products would lead to an increase in manufacturing costs.At the same time, imposing tariffs on imported products from Canada will increase costs for 82% of companies, while tariffs on imported products from China will lead to a cost increase for 70% of companies.The survey was conducted by BIO last month and involved 42 companies, nearly half of which are large enterprises with annual revenues exceeding $1 billion.More critically, 50% of the surveyed companies indicated that if EU tariffs are implemented, they would need to find new RD and production partners, and about half of the companies might be forced to delay or modify their overseas regulatory submissions.The survey further pointed out that the supply chain adjustment cycle is lengthy: 44% of enterprises expect it will take more than two years to restructure their supply chains, 36% believe it will take 1 to 2 years, and only 21% think it can be completed within 12 months. BIO CEO John Crowley warned that tariffs could "harm drug accessibility, hinder innovation, and increase unnecessary regulatory burdens." Although he supports the return of manufacturing to the U.S., he stated that the short-term impact of tariffs will cause "profound damage" to the industry.In the face of tariff threats, some American pharmaceutical companies have accelerated their domestic布局.At the end of March, Eli Lilly announced an investment of $27 billion to build four "super factories" in the United States, while Johnson Johnson plans to invest $55 billion in the U.S. over the next four years to expand pharmaceutical and medical device facilities.However, the industry generally believes that new production capacity requires 5 to 10 years to materialize, and the cost of a single factory can reach up to 2 billion US dollars, which may squeeze research and development investment.The Trump administration plans to announce a series of new tariff measures on April 2.Although Bloomberg reported that this announcement is not expected to include specific product tariffs opposed by the pharmaceutical and biotechnology industries, such tariffs are likely still in the works.Trump stated on Monday, "Tariffs on pharmaceutical products will be implemented at some point." Last month, he even explicitly warned pharmaceutical executives during a meeting at the White House to bring production back to the United States.The BIO survey results indicate that these tariff policies may, to some extent, promote the Trump administration's goal of bringing manufacturing back to the United States, but they may also run counter to the government's aim of reducing drug costs.

The review and approval of medical devices have entered an accelerated phase.01National Medical Products Administration issued a documentAccelerating the review and approval of medical devicesToday (March 27), the Center for Medical Device Evaluation of the National Medical Products Administration issued the "Notice on Further Strengthening Support for Innovative Medical Devices (No. 3 of 2025)" (hereinafter referred to as the "Notice"), clarifying that from the date of the Notice's release, guidance services for the development of innovative medical devices will be further enhanced in accordance with the requirements of "early intervention, one enterprise one policy, full-process guidance, and research-review linkage."The announcement proposes that for innovative medical device products, after the applicant completes the pre-clinical research and development work and feasibility clinical trials (if necessary), they can submit a pre-review application for the clinical trial protocol through the consultation and communication channel for major technical issues of innovative products opened by the Center for Device Review. The application should include the proposed clinical trial protocol, a summary of the rationale, relevant supporting materials, and necessary pre-clinical research data. The Center for Device Review will conduct a pre-review of the clinical trial protocol based on the applicant's request, and the pre-review comments will serve as an important reference for subsequent technical review work.For non-innovative medical device products, the applicant needs to conduct clinical evaluation according to the requirements of relevant laws and regulations. The clinical evaluation can be fully carried out by referring to the technical guidance documents released by the Center for Device Review, such as the technical guidelines for clinical evaluation of medical devices, the technical guidelines for clinical trials of in vitro diagnostic reagents, the clinical evaluation pathways of medical devices and the recommended types of clinical trials, and the publicly available technical review reports of medical device product registration, to ensure the scientific and sufficient nature of clinical evidence.In addition, the applicant must strictly fulfill their primary responsibility by establishing and maintaining an effective quality management system that is appropriate for the product. They should conduct product design and development with a focus on clinical needs, adhering to the fundamental principles of safety and performance for medical devices. After completing research on the rationale for development and preclinical trials, they should consider the product characteristics, clinical risks, and existing clinical data, and formulate a rigorous clinical trial protocol. When submitting a clinical trial protocol for preliminary review, the applicant must ensure that all submitted information is true, accurate, complete, and traceable, and they must bear the corresponding consequences and legal responsibilities.This announcement aims to implement the "Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry" (hereinafter referred to as the "Opinions") issued by the General Office of the State Council in January this year (Guo Ban Fa [2024] No. 53). It promotes the high-quality development of the medical device industry, increases support for the research and innovation of medical devices, and directs more review and approval resources toward key innovative medical devices that are urgently needed in clinical settings.The development of innovative medical devices involves high risks, substantial investments, and long cycles, and commercialization is challenging. The review and approval process, as well as hospital entry and reimbursement, significantly impact the development of related enterprises and sectors. Therefore, policy support plays a crucial role in the advancement of innovative medical devices.Recently, there has been a frequent rollout of supportive policies for innovative medical devices, encouraging innovation across the entire chain from research and development to approval and application.The "Opinions" released by the State Council in January this year covers the entire lifecycle of innovative medical devices, from RD, intellectual property protection, evaluation and approval, to post-market coordinated regulation. This high-level document will have a profound impact on the innovation and development of medical devices.The People's Daily Health Client reported that compared to the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" issued by the General Office in 2017, the "Opinions on Fully Deepening the Reform of Pharmaceutical and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry" released in January this year not only focuses on improving the efficiency of the review and approval process but also places greater emphasis on comprehensive, full-chain, and life-cycle support. It introduces specific supportive measures such as establishing systems for protecting intellectual property rights of drugs and medical devices, and active collaboration among multiple departments to support the promotion and use of innovative drugs and medical devices.02‍2025, Innovative Equipment Supports Full Chain UpgradeThe "Opinions" improve the review and approval mechanism to fully support major innovations, following the requirements of "early intervention, one enterprise one policy, full-process guidance, and research-review linkage." More review and approval resources will be directed towards key innovative drugs and medical devices urgently needed in clinical settings; the medical device standard system will be optimized, and the establishment of standardized technical organizations for cutting-edge medical devices such as artificial intelligence and medical robots will be researched; the formulation of standards for traditional Chinese medicine medical devices will be strengthened; the layout of patents for original achievements in drugs and medical devices will be accelerated, enhancing patent quality and the effectiveness of transformation and application.Research and standardize the medical insurance catalog for medical consumables and medical service items, and include innovative drugs and medical devices that meet the criteria in the scope of medical insurance payments through due process; prioritize the review and approval of high-end medical equipment such as surgical robots, brain-computer interface devices, radiotherapy equipment, medical imaging devices, innovative TCM diagnostic and therapeutic devices, and high-end implantable and interventional medical devices; reduce the review and approval time limit for clinical trials of medical devices from 60 working days to 30 working days, etc.This year, innovative devices have also become a frequently mentioned keyword by the representatives at the Two Sessions.During this year's Two Sessions, Yuan Yuyu, a National People's Congress deputy and chairman of Medprin Regenerative Medical Technologies, mentioned in an interview: "Currently, our country's technological innovation still faces the issue of technology conversion rate. If enterprises are made the main body of innovation from an early stage, and more resources and policies are directed towards enterprises, they can take the lead in promoting innovation consortiums, collaborating with universities and research institutes to jointly address specific industrial and clinical issues. This would make innovation more efficient, closer to the market, more aligned with industrial needs, and better at driving innovation from a conversion perspective."National Committee member of the Chinese People's Political Consultative Conference and Executive Vice President of the Chinese Society of Cardiothoracic Anesthesiology, Ao Hushan, introduced that his focus at this year's Two Sessions is to eliminate institutional barriers and pave the way for the entry of innovative medical technology products into hospitals to empower patient health.Ao Hushan stated that during this year's Two Sessions, he will focus on proposing the refinement of the evaluation mechanisms for hospitals by the National Health Commission and the National Healthcare Security Administration. He aims to establish a green channel at the national policy level to facilitate the entry of innovative medical products into hospitals, while simultaneously optimizing the medical insurance reimbursement system. Additionally, he advocates for appropriately increasing reimbursement amounts for scientifically validated innovative medical products.Nowadays, the volume-based procurement covering all categories has also created a window period for innovative medical devices. In several consumable centralized procurement projects this year, it has been mentioned that "innovative medical devices recognized by provincial or higher drug supervision departments are not included in the volume-based procurement scope."The payment policy is further broadening the "development" space for innovative devices. For instance, at the end of last year, Anhui proposed to improve the special case negotiation mechanism for DRG/DIP payments, allowing medical institutions to independently apply for special case negotiations for cases involving the use of new drugs and technologies. It encourages commercial insurance companies to develop targeted commercial health insurance products covering innovative drugs and devices. It also guides commercial insurance to optimize claims processes, promoting direct settlement of commercial health insurance covering relevant innovative drugs and devices.With the continuous implementation of top-level design documents, various supporting measures will be further improved, and the golden period of medical device innovation has arrived.

Recently,Xuhui District, ShanghaiPublished supportive opinions on the development of the synthetic biology industry.The opinions focus on the development directions of the synthetic biology technology industry, mainly in four key support areas:(1) Basic layer technologies related to gene editing, synthesis, and sequencing, including nucleic acid synthesis, DNA sequencing, tool enzymes, and other fields;Digital-assisted product development and成果转化, integration of synthetic biology with cutting-edge technologies such as artificial intelligence and large models; including fields such as intelligent design and optimization, high-throughput screening equipment, etc.(3) Applications in the field of life and health, including cell and gene therapy, active pharmaceutical ingredients and intermediates, natural products and their derivatives, diagnostic reagents and enzymes, bio-based materials, high-end cosmetic ingredients, functional foods, and other areas.(4) Industrial supporting services, including optimization of the industrial chain ecosystem, spatial support, and construction of functional platforms.In terms of support policies, to accelerate the gathering of high-quality enterprises: incentives may be provided to attract and promote enterprises that align with regional industrial development orientation.Up to 10 million yuanOne-time support; enterprises that have a significant driving effect on industrial and regional development may be granted.Up to 30 million yuanReward.In addition, relevant policy support has also been provided in areas such as enhancing the innovation capability of industries, supporting the construction of industrial platforms, promoting product innovation and development, supporting the construction of application scenarios, strengthening industrial space guarantees, accelerating financial empowerment for industrial development, and implementing detailed talent service guarantees.

The Terminator for Consumables Payment Dilemmas is Here?01Many places across the countryThe healthcare insurance fund shifts from "post-payment" to "pre-payment".On March 24, the Zhejiang Provincial Medical Insurance Bureau issued the "Notice of the Zhejiang Provincial Medical Insurance Bureau and the Zhejiang Provincial Department of Finance on Printing and Distributing the Prepayment Management Measures for Basic Medical Insurance Funds in Designated Medical Institutions in Zhejiang Province" (hereinafter referred to as the "Notice").In November last year, the National Medical Insurance Administration, in conjunction with the Ministry of Finance, issued the "Notice on Properly Carrying Out Medical Insurance Fund Prepayment Work," which clarified the connotation, conditions, and standards of the medical insurance fund prepayment policy, standardized the management of the prepayment process, accounting, and fund supervision, and pointed out that localities should implement the fund prepayment work according to the requirements of the notice.The prepaid funds of the basic medical insurance fund are set up as working capital to help designated medical institutions alleviate the pressure of medical expense advances, improve medical service capabilities, and enhance the sense of gain for insured patients when seeking medical treatment. These funds are used for expenditures such as the procurement of medicines and medical consumables.Medical institutions applying for advance payment must meet certain conditions.The above document from Zhejiang clearly states that designated medical institutions within the coordinated area that meet the following basic conditions can apply for prepayment funds:The specific process of the advance payment procedure is as follows:(Chart: Cyble Blue Medical Devices) Meanwhile, if designated medical institutions have any of the following circumstances, the medical insurance department should promptly reclaim the advance payment.According to the Notice, a prepayment fund equivalent to 1 month will be allocated to designated medical institutions that meet the prepayment criteria. For designated medical institutions in the same coordinated area where the growth rate of basic medical insurance fund expenditures for the previous year was ≤5%, the comprehensive settlement or medical insurance performance assessment results for the most recent year were excellent, and they performed outstandingly in key medical insurance tasks, local areas may appropriately increase the scale of the prepayment fund based on actual circumstances, but it shall not exceed 2 months.According to statistics, as of now, many regions such as Hunan, Yunnan, Zhejiang, Hubei, Inner Mongolia, Tibet, and Hebei have issued documents to promote the establishment of a prepaid fund management system. Previously, Guizhou, Heilongjiang and other places have also publicly solicited opinions on the management measures for prepaid medical insurance funds.The shift in medical insurance fund settlement from a "post-payment system" to a "pre-payment system" will significantly alleviate hospitals' financial burden of advance payments and improve fund turnover efficiency. Under this chain reaction in the settlement turnover process, upstream players in the industry such as pharmaceutical companies and medical supply manufacturers will also benefit, with the issue of triangular debt in payments expected to ease.02"Three Settlements" is fully promotedCan the dilemma of material reimbursement be resolved?The issue of reimbursement for consumables has always been difficult to resolve.Previously, Saibailan Medical Devices conducted a small-scale survey on the payment cycle of medical consumables, with a total of 281 participants voting. The voting results showed that the payment situation for centralized procurement (CP) medical consumables was significantly better than that for non-CP medical consumables. Forty-nine percent of the participants indicated that the payment cycle for CP medical consumables could be controlled within half a year. However, 84 participants stated that the payment cycle for the medical consumables related to their business had extended to more than one year.The payment cycle for non-centralized procurement medical consumables is even longer, typically ranging from 1 to 2 years. However, 13 participants reported that their non-centralized procurement consumables could be paid within 3 months.It is not hard to see that there are significant differences in the repayment situations across various regions and medical institutions, with many areas still experiencing prolonged repayment times.In 2025, the "three settlements" of medical insurance became a hot topic in the field of drug and device payments. The national and local levels are vigorously promoting new measures, which are expected to solve the issue of triangular debts in payments.Since the beginning of the year, the National Healthcare Security Administration has intensively disclosed the progress of the "three settlements" healthcare reform across multiple regions in the country, including provinces such as Beijing, Henan, Hubei, Anhui, Jiangxi, and Hainan. Reform measures in cities like Xiamen (Fujian), Anyang (Henan), Zhengzhou (Henan), Yunfu (Guangdong), Hami (Xinjiang), Binzhou (Shandong), and Dalian (Liaoning) have also been shared as case examples.The "three settlements" in medical insurance refer to the immediate settlement between the medical insurance fund and medical institutions, the direct settlement between the medical insurance fund and pharmaceutical enterprises, and the simultaneous settlement between the medical insurance fund and commercial insurance, etc.Previously, local governments have made many explorations in direct settlement. With the acceleration of instant settlement and synchronous settlement, the payment for consumables is expected to be fully expedited.On March 26, the National Healthcare Security Administration disclosed the progress of the "three settlement" healthcare reform in Anyang, Henan. The report indicated that the region has preliminarily achieved the coordinated goal of "real-time settlement, direct settlement, and simultaneous settlement" across the entire healthcare fund chain.In terms of instant settlement, the reimbursement time limit for medical insurance funds has been compressed from 30 working days after the designated medical institution's declaration to as short as 1 working day, with the first batch of 16 medical institutions included in the pilot program; direct settlement has expanded from 1 designated medical institution to 14, and the payment cycle for pharmaceutical distribution companies has been shortened to 25 days; a "one-stop" service window has been established in 5 pilot hospitals, achieving synchronous settlement for basic medical insurance and "Anhui Bao."In terms of timing, the National Medical Insurance Administration has made it clear that by 2025, the nationwide basic implementation of direct settlement for centrally procured medicines and consumables, as well as national negotiation medicines, will be achieved. By 2026, direct settlement for these will be fully realized nationwide. Additionally, by 2025, about 80% of the coordinated regions will basically achieve instant settlement of basic medical insurance funds with designated medical institutions, and by 2026, all coordinated regions will realize instant settlement of basic medical insurance funds with designated medical institutions. The collection of consumables payments is expected to usher in a new era.

Foreign capital and private enterprises, like "catfish," have successively entered the market, marking a new turning point for China's healthcare market.01 Focus on non-public and foreign investmentMultinational medical device giants bet on ChinaRecently, the roundtable meeting on "Implementing a Health-First Development Strategy, Promoting the Coordinated Development and Governance of Healthcare, Medical Insurance, and Pharmaceuticals" at the China Development Forum 2025 Annual Meeting was held in Beijing.At the meeting, Lei Haichao, the director of the National Health Commission, mentioned the importance of leveraging the role of the non-public economy and foreign investment in the field of health and wellness. He hopes that Chinese and foreign enterprises will strengthen their confidence in development and actively participate in deepening medical reform, strengthening healthcare infrastructure, prevention and control of key infectious diseases and chronic diseases, pediatric and mental health services, high-quality population development, and pharmaceutical innovation.From the recent actions taken by the state in the healthcare sector, it is evident that non-public and foreign-funded economies are increasingly playing a significant role, with corresponding policy support also being rolled out successively.In February this year, the Ministry of Commerce and the National Development and Reform Commission issued the *2025 Action Plan for Stabilizing Foreign Investment* (referred to as the *Plan*), which mentioned expanding pilot openings in the medical field, including supporting pilot regions in promoting and implementing open pilot policies in value-added telecommunications, biotechnology, and wholly foreign-owned hospitals.The Plan clearly states that for areas outside the negative list for foreign investment access, the management of foreign investment access must be strictly implemented according to the principle of equal treatment for domestic and foreign investment. The negative list for market access will be revised to further reduce the number of items on the list, expanding openness to all types of business entities.During the 2025 annual meeting of the China Development Forum, multinational medical device giants such as Medtronic and Siemens expressed their commitment to investing in China, and recent achievements have already been realized.On March 24, the signing and unveiling ceremony of Medtronic's Digital Medical Innovation Base took place at the International Pharmaceutical Innovation Park, marking Medtronic's first digital medical innovation base established in China.Medical devices are a capital-intensive industry, and due to their impact on public health, their business development is strongly correlated with policy directions. Additionally, as the domestic medical device industry is rapidly rising, it has already formed direct competition with multinational companies.For the national level, if it wants to attract continuous foreign investment in the domestic medical device field, it clearly needs to provide sufficient sincerity in policy terms.As early as 2021, the Ministry of Finance clearly stated in the "Notice on Implementing Policies to Treat Domestic and Foreign Enterprises Equally in Government Procurement Activities" that in government procurement activities, except for procurement projects involving national security and state secrets, products produced by domestic and foreign enterprises within China should not be treated differently.The "2025 Action Plan for Stabilizing Foreign Investment" also reiterated the need to continuously optimize the business environment and effectively implement national treatment for foreign-funded enterprises.The protection and support of national policies can provide confidence for foreign investment, but for foreign medical device companies, the true core attraction remains China's vast product demand, which has been fully demonstrated in recent market trends.In December 2024, the fifth batch of national centralized procurement of medical consumables opened for bidding, with the price of cochlear implant consumables (including the implant and speech processor) dropping from an average of over 200,000 yuan to around 50,000 yuan, attracting significant attention. The lowest winning bid for peripheral vascular intervention consumables was 2,280 yuan, a reduction of more than 50%.In this intense price war, foreign-funded companies have shown extremely high participation enthusiasm, securing first place in all four categories (cochlear implants and three peripheral vascular stent groups) with leading foreign enterprises winning the bids. This demonstrates that as long as the overall market size is sufficiently large, foreign companies are willing to make price concessions to gain market share.According to the "China Medical Device Industry Blue Book (2024)", the market size of China's medical device industry showed a year-on-year upward trend from 2016 to 2023. In 2023, the market size of China's medical device industry reached 1,032.8 billion yuan, increasing by 5.07% year-on-year, with a compound annual growth rate of 16.12% from 2016 to 2023.With the continuous optimization of the business environment for foreign investment, the strong capital-attracting power inherent in such a vast market will accelerate its realization, and the domestic medical device industry will also enter an era of full competition.02The hospital sector is accelerating its opening-up.The spring of high-end private healthcare is coming.If the medical device sector has traditionally been a stronghold for non-public economy, and expanding foreign access is a routine move, then recent pilots for foreign hospitals demonstrate the country’s resolve in opening up.In November last year, the National Health Commission, the Ministry of Commerce, and three other departments jointly issued the "Pilot Work Plan for Expanding Opening Up in the Field of Wholly Foreign-Owned Hospitals," allowing the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the whole Hainan Island.As of now, Tianjin, Shanghai, Guangzhou, and Shenzhen have announced the establishment of wholly foreign-owned hospitals, with several already in operation.According to national plans, foreign-funded hospitals in the pilot program must meet the conditions of "being able to provide internationally advanced hospital management concepts, management models, and service models" and "being able to provide medical technologies and equipment at an internationally leading level." This means that it is expected for foreign-funded hospitals to engage in high-end business, and it also represents a new market growth space for domestic high-end medical equipment and innovative drugs.For instance, Guangzhou Baiyun Prime Healthcare Hospital will focus on introducing cutting-edge international technologies such as CAR-T cell therapy, T-cell receptor engineering, targeted therapy, and gene editing, while promoting the alignment of Guangzhou's medical technology, medical equipment, management philosophy, and service model with international standards.Tianjin Pengruili Hospital has basically coordinated 150 kinds of imported drugs and original research drugs. It can apply for innovative drugs and medical devices that have been approved abroad but have not been approved in China, and the fastest approval can be obtained through the local drug regulatory authorities in one month. In addition to foreign investment, there have been consecutive significant announcements in the local non-public medical sector.The Beijing Municipal Health Commission recently issued a notice titled "Approval for Douyin Group's Establishment of the Beijing Aiyi Hospital (Tentative) Project" on its official website. According to the public registration change information for Beijing Aiyi Hospital (Tentative), the hospital is a for-profit, tertiary comprehensive Sino-foreign joint venture with 800 beds.Tencent-backed premium comprehensive healthcare provider United Family Healthcare (UFH) has updated its prospectus after its initial attempt to list on the Hong Kong Stock Exchange in May last year. Currently, UFH owns and operates 20 healthcare facilities across China, including 18 clinics and two hospitals.Private hospitals in China have developed for many years but have failed to overcome their own challenges.According to the "2022 Statistical Bulletin on the Development of China's Health and Wellness Sector," by the end of 2022, there were a total of 36,976 hospitals nationwide in China, including 11,746 public hospitals and 25,230 private hospitals.Although the overall number has achieved a reversal, the situation of private hospitals being "small, scattered, and chaotic" has not been fundamentally changed. According to the 2022 data, the total number of hospital beds nationwide is 7.663 million, with public hospitals accounting for 70.0%, while the more numerous private hospitals only account for 30.0%.In addition, compared to domestic public hospitals, non-public medical institutions face greater operational pressures. According to the "China Health Statistics Yearbook 2021," the 23,500 non-public medical institutions nationwide reported a combined annual loss of 130 billion yuan, averaging a loss of 5.53 million yuan per institution.In response to the national signal emphasizing the important role of non-public capital and foreign capital in the healthcare sector, the domestic medical ecosystem is expected to undergo new changes. From the pilot opening of foreign-owned hospitals to the entry of local capital such as Douyin (TikTok) and Tencent, the spring of non-public hospitals may be on its way. In the current development trend, local medical device enterprises and public hospitals may face new challenges. But this is essentially a matter of expanding and dividing the pie. The domestic medical market has passed the period of savage growth, and the importance of stimulating potential demand is increasing day by day.The efficiency of high-end exploration in domestic healthcare is expected to significantly improve through the stimulation of non-public and foreign capital. If the domestic healthcare market can be further expanded successfully, all participants will benefit.

The notice was issued by the State Administration of Medical Equipment of the Public Security Bureau to announce the plan of revising and standardizing the standards for the medical equipment industry in 2025, and 79 standards were included in the mandatory standards revision project, and 6 standards were included in the recommended standards revision project.According to the notice, among the six standards included in the 2025 mandatory industry standards formulation and revision plan for medical devices, "General Technical Requirements for Thermal Conduction Physiotherapy Equipment" is a new standard to be established, while the other five are revisions, such as "Anesthesia and Respiratory Equipment - Manual Resuscitators," "Intravascular Catheters - Single-use Sterile Catheters Part 4: Balloon Dilatation Catheters," and "Laser Therapy Equipment - Holmium Yttrium Aluminum Garnet Laser Therapy Machines." The units responsible for the formulation and revision of these six standards are the Shanghai Institute of Medical Device Inspection and Research, Tianjin Medical Device Quality Supervision and Inspection Center, and Shandong Institute of Medical Devices and Drug Packaging Inspection, among others.Among the 79 recommended industry standards for medical devices included in the 2025 revision and development plan, 54 are new developments, such as "General Rules for Degradation Test Methods of Recombinant Collagen Protein," "Performance Testing Methods for Artificial Intelligence Medical Devices - CT Image Analysis Software for Bone Fracture Assistance," and "Requirements and Test Methods for Puncture Surgery Navigation Equipment Using Robotic Technology." Twenty-five are revisions, including "Performance and Test Methods for Radiotherapy Planning Systems of Automatic Control Proximity Treatment Afterloading Equipment," "Fully Automatic Urine Sediment Analyzer," and "Tubal Cannula." The organizations tasked with developing and revising these 79 standards include the China National Institute for Food and Drug Control, Liaoning Provincial Institute for Medical Device Inspection and Testing, Guangdong Provincial Institutes for Product Quality Supervision and Inspection of Medical Devices, among others.

Medical device centralized procurement has entered a normalization stage, and high-value orders are beneficial for domestic products.01Fujian CT and MR medical equipment centralized procurement has arrived.Recently, the China Government Procurement Net published the "Notice of Public Bidding for the Procurement of CT and MR Medical Equipment for Fujian Province in 2024" (shortened as "the Notice"), with a total budget of 8.97 billion RMB and a total quantity of 92 units.According to the announcement, this equipment procurement in Fujian is divided into 7 procurement packages, which are 256-slice and above CT Package 1, 256-slice and above CT Package 2, 1.5T and above MR Package 1, 1.5T and above MR Package 2, 3.0T and above MR Package 1, 3.0T and above MR Package 2, and 3.0T and above MR Package 3. The details of each package are as follows:赛博乐器械制图（SBG，SAβlekohärtung und Kabelherstellung GmBH）是一家德国基于数字技术和合金技术发展的机器制造商。errorThe 2024 64 and above procurement projects for CT collection have also published procurement notices, and the amount and quantity of the procurement are the same as the notice. In total, the province of Fujian since the beginning of the year has issued orders for over 10 billion level of equipment collection projects.Compared to the relatively lower-priced medical consumables, the domestic medical equipment market has a lower profile for domestic brands, and is long dominated by multinational giants. Drawing from the experience of consumables centralized procurement, the "price-for-volume" model clearly benefits domestic brands' entry into hospitals. Furthermore, the recent series of tender announcements in Fujian specifying "domestic brands only" are expected to directly empower the rise of local medical equipment manufacturers.Moreover, even setting aside the support for domestic products in the purchasing end, the competitiveness of domestic medical equipment has already changed beyond recognition.On March 4th, Hainan announced the latest results of its medical equipment procurement. In a procurement order totaling 200 ultrasound units, Mindray Medical won 60 units, with a total bid amount of nearly 99 million yuan. Following Mindray, Neusoft Medical won 18 units, with a bid amount of 10.08 million yuan. Among foreign brands, only GE Healthcare survived, winning 13 ultrasound units with a bid amount of 9.36 million yuan.According to a research report by Changjiang Securities, the localization rate of equipment was 19% in 2019 and is expected to rise to 43% by 2024. The average annual increase in localization rate over the past two years has been 3 percentage points, and there is still room for improvement in the future.022025 Medical Equipment Procurement RecoveryReleasing mass-scale potential at the grassroots level‍‍The collection and procurement of medicines and consumables has been promoted for many years, but due to objective factors such as high prices, varying usage scenarios, and difficulty in standardizing parameters, the overall progress of medical equipment procurement has been relatively slow. However, with the gradual accumulation of pilot experiences in various regions in recent years, relevant plans for equipment procurement have been increasingly refined, and there has been a noticeable acceleration in recent times.As a "pioneer" in centralized procurement of medical equipment, Anhui province has taken the lead in the country since 2020 by conducting centralized procurement of Class B large medical devices for public medical institutions at the provincial level. Recently, it officially announced the launch of the centralized procurement work for Class B large medical devices in the province for the year 2025.According to the announcement from Anhui Province, for all public medical institutions in the province using non-budgetary funds and holding valid Class B large-scale medical equipment configuration permits, Class B large-scale medical equipment planned for procurement in 2025 shall participate in the provincial centralized procurement, to be organized once this year.Guangxi is also accelerating its efforts, proposing to organize centralized volume-based procurement starting in May each year, with at least one round annually. It specifically mentions that medical and health institutions using fiscal funds to purchase imported medical equipment should undergo the import equipment review organized by the relevant industry authorities and obtain approval from the financial departments at the municipal level or above.Moreover, including the provinces mentioned earlier such as Hainan, city-level medical equipment procurement representatives like Suzhou, as well as various county-level medical institution consortia, have conducted their respective medical equipment procurement work according to their own needs, largely overcoming the inherent difficulties of medical equipment procurement through the layered purchasing model.While procurement of medical devices stimulates the market, overall market expansion driven by large-scale equipment updates has already shown initial signs of success, with the medical equipment market growing bigger with each step.According to statistics compiled by Medical Equipment Update Recruitment, as of March 2, 2025, there have been a total of 697 projects related to medical equipment更新招标公告 in China's medical field, among which 570 projects have disclosed the budget amount, totaling 8.1 billion yuan.According to previous experience, a large number of equipment renewal procurement projects initiated at the beginning of the year are likely to be concentrated in the third and fourth quarters, while orders for medical equipment updates in various regions continue to be updated. 2025 is expected to become a new peak year for medical equipment procurement.It is worth noting that the base market is one of the main beneficiaries of the device cluster development and the large-scale equipment upgrade.Long-term, domestic medical equipment mainly supplies in domestic second- and third-tier cities, hospitals of county-level and below, the driving force of purchasing and upgrading of medical equipment is relatively weak, and the high price of medical equipment is the main cause.In the above two tasks, the ability of centralized procurement to squeeze out inflated prices has been fully verified in the field of medical consumables, and the focus on large-scale equipment upgrades for grassroots and underdeveloped areas has also been clearly stated in the documents.For example, Zhejiang has clearly stated that it will focus on the renewal of medical equipment at the county level, requiring that by 2027, the equipment configuration compliance rate of medical and health institutions at and below the county level reaches 100%.The notice issued by the National Development and Reform Commission and the Ministry of Finance regarding the enhancement and expansion of the large-scale equipment updating and consumer goods exchange old for new policy in 2025 states that the overall funding allocated directly to local governments will be implemented according to a 9:1 central-local shared responsibility principle, with central government share being 85% for East, 90% for Middle, and 95% for West regions.The level of advantages in the base market of medical equipment in the rural areas has been shown on the data. The purchase of medical equipment in county-level in September and December 2024 was 14.5% and 22.6%, respectively, with a negative growth rate previous to which were 14.5% and 22.6%, respectively.A new paradigm shift has arrived in the medical device market.

What are the new features of consumables price management in 2025?015 categories of consumables centralized procurement continuationLowest price linkage "loosened"?On March 20, the Jiangsu Medical Insurance Bureau issued an "Announcement on Publicly Soliciting Opinions for the Continuation Procurement Plan of the Seventh and Eighth Rounds of Medical Consumables Centralized Procurement," deciding to carry out the continuation procurement for the seventh and eighth rounds of medical consumables centralized procurement in Jiangsu Province.Purchasing varieties include:endoscopic stapler, neuro-specific coil, ultrasonic scalpel head, vacuum blood collection tube2. Orthopedic trauma: locking compression plate system, regular plate system, intramedullary nail system, screws used individually.Variety classification is as follows:In terms of the selection rules, endoscopic staplers, neuro-specific coils, ultrasonic scalpel heads, vacuum blood collection tubes, separately chargeable screws, and orthopedic plates, still follow the common procurement model of the lowest price linkage. The quoted prices must not be higher than the lowest winning bid prices of the products in the centralized procurements across various provinces.However, in the selection rules for bone plates and intramedullary nails, it is only stated that "the system quotation should not be higher than the original winning price of the same system in Jiangsu by the originally selected company in Jiangsu, to be considered as a potential winner," without mentioning the linkage to the lowest procurement price from other provinces. Currently, the document is a draft for comments, and it is uncertain whether this will be supplemented in the official document.At present, the lowest price linkage model has been basically implemented in the procurement of consumables and online procurement. Previously, the low-price linkage was mainly declared by the enterprises themselves, but after a comprehensive upgrade of the procurement system, data interoperability has been achieved. Under this trend, any reduction in the price of consumables in one place will affect the national price of the product. Therefore, enterprises must consider the product pricing comprehively.[Map: Cailian器械]In terms of the allocation of procurement volume under the agreement, while taking into account the autonomous choice space of medical institutions, the Jiangsu follow-up procurement document also tilts the allocation of procurement volume towards enterprises with relatively larger price reduction through rule design. In addition, for domestic products of import enterprises, the document clearly states that they will be regarded as new products of import enterprises and participate in this follow-up procurement.So far, Jiangsu Province has completed 10 rounds of volume-based procurement for medical consumables, with the products covering multiple fields such as cardiology, orthopedics, general surgery, ophthalmology, neurosurgery, and laboratory testing. The majority of the procured consumables are high-value items, but also include some commonly used ones with large clinical volumes. In the 10th round of procurement, Jiangsu innovated its procurement model by pioneering the procurement of medical services, overcoming the difficulties in the procurement of laboratory testing.[Mapping: Cailian Blue Device] 02comprehensive governance of drug and consumable pricesInnovation field has new moves‍‍‍‍‍Since 2018, the management of consumables prices has been continuously deepened.As an important means of squeezing out the price水分of consumables, volume-based procurement has basically achieved full coverage of major categories. According to the plan of the National Healthcare Security Administration, the 6th batch of high-value medical consumables centralized procurement will be carried out in the second half of this year. At the same time, it is expected that around 20 specialized national alliance procurements will be conducted at the local level (including traditional Chinese medicine, Chinese herbal decoctions, and high-value consumables, etc.). 注：在翻译过程中，“价格水分”是一个比较难以直接翻译的概念，通常指的是商品或服务的价格中不合理的部分或虚高的成分。如果需要更贴切的表达，可能需要根据上下文调整为如“unreasonable price components”或者“price bubbles”。但按照要求，这里直接翻译为了“price水分”。At the local level, four medical consumables alliances are scheduled for centralized procurement by 2025. Hunan will lead the national joint procurement of high-frequency electric knife heads; Hebei will take the lead in the centralized procurement of aortic stents and abdominal aortic stents; Fujian will lead the national joint procurement of 1-2 categories of consumables; Heilongjiang will lead the centralized procurement of vena cava filters and ablation electrode consumables.In addition, the comprehensive management of "consumables + services" pricing is being gradually advanced.Not long ago, the field of central venous administration underwent such a round of comprehensive price management. In terms of consumables, the National Medical Insurance Administration guided the medical insurance departments of relevant provinces to hold talks with 68 domestic and foreign production enterprises and import agents, urging companies to actively reduce excessive markups in intermediate distribution channels, lower terminal listing prices, and promote relative coordination between centralized procurement winning bid prices and listing prices.Taking the infusion port as an example, before the price regulation, the prices of high-pressure resistant infusion ports from various companies were concentrated between 5000 yuan and 10000 yuan. After the price regulation, most companies voluntarily committed to adjusting their sales prices to below 2700 yuan. At the same time, for individual companies whose prices after rectification are still significantly higher than similar products, a "red and yellow label" management is implemented. When medical institutions place orders on the centralized procurement platform, they are reminded of the price risk through pop-up warnings (it is still up to the medical institution to decide whether to continue purchasing).At present, the country is vigorously promoting the compilation of guidelines for medical service price project initiation and guiding localities to standardize and integrate existing price projects. Notably, it also leaves more room for innovative technologies.In the "Guidelines for the Establishment of Medical Service Price Items for Cardiovascular System (Trial)" released on March 7, it is clearly stated that new price items such as "Ventricular Assist Device Implantation Fee," "Ventricular Assist Device Removal Fee," and "Cardiac Implantable Device Fitting Fee" will be uniformly added nationwide, which benefits the clinical application and promotion of artificial hearts.At the same time, the National Medical Insurance Administration has communicated individually with five domestic and foreign-funded manufacturing enterprises that have been approved for market release, guiding the companies to appropriately reduce the terminal listing price of "artificial hearts." Among them, Aerospace Tixin has committed to reducing the price to 499,000 yuan per set, lowering the overall cost of "artificial heart" implantation surgery from a million-level to around 700,000 yuan.Currently, the governance of medical prices has entered a deep-water zone, and a more scientific and refined price revolution will continue. It is expected that in the future, the prices of consumables in innovative frontier fields will gradually decrease. At the same time, this will also promote the accelerated application of valuable innovative technologies in clinical settings, advancing the commercialization process.

The low-cost linkage model for consumables is still being adjusted, with "three-province prices" transitioning to "lowest price," and multiple provinces are simultaneously initiating price monitoring for consumables.01The era of "prices no lower than three provinces' prices" has ended.Scrutinize abnormal high and low pricesOn March 17th, the Qinghai Provincial Medical Insurance Bureau released a "Notice on Regulating the Direct Listing Prices and Procurement Requirements of Medical Consumables and In Vitro Diagnostic Reagents," adjusting the direct listing prices and procurement requirements for medical consumables and in vitro diagnostic reagents.Starting from May 1st, for medical consumables and in vitro diagnostic reagents that have been listed on the network, products with the national lowest procurement prices of three provincial levels will only retain their lowest listed prices nationwide. Products with only one provincial listed price or declared price will retain their listed prices.Relevant enterprises should proactively monitor the standardized adjustment of their挂牌价格 on the Qinghai Province Procurement Platform. If the national minimum挂牌价格 (including actual transaction prices) is lowered in other provinces, they should actively initiate price linkage and submit a price adjustment application to the Provincial Drug Procurement Center within 30 days. The Provincial Drug Procurement Center should promptly adjust the挂牌价格 and implement dynamic management.Production enterprises should strictly adhere to the principle of honesty and integrity, and not exceed the national minimum purchase price (including transaction price) or the enterprise's reported price. The enterprises should not submit the national minimum three provinces provincial procurement price. The medical equipment and supplies products shall be submitted to the national medical insurance bureau through a unified portal in one step, and the medical equipment and supplies products shall be verified by one province.Public medical institutions shall refer to the listed prices reported by enterprises for online bidding and negotiate procurement prices with enterprises, which shall not exceed the listed prices.Prior to this notice, Qinghai Province had, through consultations with online market entities, urged timely updates and confirmation of online prices, resulting in the disposal of 3747 abnormal online pricing products across 10 batches, including 37 pharmaceutical products, 3586 medical consumables, and 124 diagnostic reagents, with the maximum reduction of 95.67% and an average reduction of 34.93%.Also effective May 1st, the Hunan Provincial Medical Insurance Bureau released the "Notice on Establishing a Monitoring and Disposal Mechanism for Medical Price Information in Hunan Province." The document emphasizes monitoring information on the following: regions and medical institutions where medical expenses have increased excessively, grown too quickly, have unreasonable structures, or where residents' medical burdens have significantly increased; unfair high prices, discriminatory high prices, and malicious low prices of drugs and medical consumables. The monitoring of price information will be used to strengthen the self-discipline of medical institutions and guide the public towards rational medical treatment and medication purchases.The specific monitoring content is as follows:The listed prices of consumables are also within the monitoring scope. The document requires that medical security departments at all levels regularly collect the listed prices of drugs and medical consumables from the Hunan Provincial Medical Procurement Platform, as well as the actual transaction price information generated from trading orders.In this price monitoring scope in Hunan, not only high-priced products but also abnormally low-priced products will be monitored. The time, location, price difference, and frequency of unfair high prices, discriminatory high prices, and malicious low prices caused by market恶性competition will be monitored and analyzed. The analysis results will serve as important leads for identifying and rectifying issues such as inflated listed prices, drug diversion, and fake drugs.Except for Qinghai and Hunan, provinces such as Jiangsu, Heilongjiang, Inner Mongolia, Shaanxi, Hebei, Gansu, and Shandong have also successively launched governance work related to the pricing of consumables. Enterprises that fail to adjust their products in accordance with the requirements in a timely manner will face penalties such as removal from the network and credit score deductions.02‍Government InterventionDeepening and Unification of Consumables Online Listing ReformThe main focus of the work in the medical insurance field this year is the "Efficient Implementation of One Thing" in the medical insurance sector of the 2025 annual first batch of key tasks issued by the State Administration of Medical Insurance Office in February. The State Administration of Medical Insurance Office issued the "Medical Insurance Sector 'Efficient Implementation of One Thing' 2025 Annual First Batch Key Tasks Clearing List", requiring medical products to be registered nationwide through the unified portal of the provincial or multiple provincial websites. Companies can submit medical products and prices through the unified portal of one province or multiple provinces, submitting the data once, and verifying the information nationwide.With the promotion of national joint review and handling, the process for enterprises to register online has been significantly simplified, allowing for a "one-step" completion of the registration work. At the same time, price supervision has become more transparent and timely, further reducing the space for false reporting.Local price data sharing is also being promoted. In October last year, the Shaanxi Provincial Public Resources Trading Center organized a price comparison of drugs and medical consumables listed online. The comparison was based on the online listing data from the Shaanxi platform and compared with the platforms of Guangxi, Shandong, and Anhui provinces. For some products found not to meet the requirement of linking to the lowest listed price from other provinces, their listing qualifications were revoked, and no applications for listing that product would be accepted for one year.While price linkage for挂网 (public tender) is implemented, the credit evaluation and punishment mechanism will be strengthened. Actions such as false declaration and untimely delivery will be subject to credit scoring systems, affecting companies' qualifications to participate in volume-based procurement.Furthermore, the regulatory blind spots in the penalty mechanism have been further eliminated. Hunan has now stipulated the handling of abnormal price information for medicines and medical consumables. By referring to the risk management measures and relevant guidelines of the national medical security department, measures such as price verification, written inquiries, cost investigations, and price interviews will be taken to urge enterprises to proactively standardize their pricing behavior; for those who refuse to rectify without valid reasons or fail to rectify adequately, public inquiries will be conducted to require companies to publicly explain their specific pricing situations; for those who still refuse to rectify after public inquiries, credit evaluation measures will be imposed according to regulations; for enterprises reporting production halts and supply suspensions hoping to avoid price rectification, penetration to the marketing authorization holders will be made to prevent evasion of regulation through related party transactions.The government's supervision of procurement also gradually extended to the online purchase market, as for example the Shanghai Medical Insurance Bureau issued a notice urging local medical institutions to actively push for self-service price negotiations for goods sold online through the "Sun Yang Hang" price regulation project, and for enterprises in the South of Shanghai to voluntarily participate in self-service price negotiations with designated medical institutions in the South. To this end, local medical institutions which had been authorized to buy the drugs and non-separate use medical consumables via online purchases would be granted bonus prizes of remaining funds, every year by March in accordance with the self-service price negotiations results, for every year's remaining funds the same was paid out.With the improvement of price supervision regulatory mechanisms, cross-provincial price data sharing and the promotion of the "national unified examination and approval" mode, regional differences in consumable prices will be gradually eliminated, and a unified national minimum price system will be accelerated.Attached:

Another large-scale alliance centralized procurement announcement, involving two types of high-value consumables.01Inferior vena cava filter, ablation electrode centralized procurement approachingpay attention to the company's ability to bear‍‍‍‍On March 19, the Heilongjiang Public Resources Trading Center issued the "Notice on Holding a Symposium for Enterprises Participating in the Centralized Procurement of Vena Cava Filter Ablation Electrode Medical Consumables" (hereinafter referred to as the "Notice").According to the Notice, Heilongjiang plans to lead the centralized procurement of vena cava filters and ablation electrodes in 2025, and a symposium for enterprises on centralized volume-based procurement is scheduled for March 21. It requires that one representative from the medical device registrants related to vena cava filters, vena cava filter retrieval kits (C02063506, C02063606), and ablation electrodes (C010506021, C010507021) attend.last DecemberAt the Heilongjiang medical insurance work conference, it was clearly mentioned that the mechanism for drug procurement and implementation needs to be further improved, which has been reflected in the preparatory stage of this round of vena cava filter and ablation electrode procurement.In addition to requiring companies to introduce their products, production capacity, sales, and prices, the discussion at this meeting in Heilongjiang also included "companies' expectations and affordability regarding centralized procurement prices," "measures taken by companies in response to changes in demand after centralized procurement," and "suggestions for centralized procurement rules."Due to the limited information currently disclosed, the scope of this round of vena cava filter and ablation electrode centralized procurement cannot be determined. However, from the expression "led by Heilongjiang" in the Notice, it is highly likely to be at the inter-provincial alliance level.On January 17, at a press conference of the National Healthcare Security Administration, it was mentioned that the sixth batch of high-value medical consumables centralized procurement will be carried out in the second half of the year. At the same time, it is expected that around 20 national alliance procurements with professional characteristics will be conducted at the local level, including traditional Chinese medicine, Chinese herbal decoctions, and high-value consumables.So far, Hunan has clearly stated that it will lead the national joint procurement of high-frequency electric knife head medical consumables; Hebei has also put the centralized procurement of aortic stents and abdominal aortic stents on the agenda; Fujian has also proposed a plan to lead the national joint procurement of medical consumables at the medical insurance meeting.It is reported that two types of consumables, vena cava filters and vena cava filter retrieval kits, had participated in the information maintenance work for the fifth batch of national medical consumables procurement, but they did not enter the formal procurement documents.Combining the above information, the centralized procurement of vena cava filters and ablation electrodes led by Heilongjiang also has the potential to be upgraded to a national alliance procurement.02potential market accelerating expansionDomestic players ride the collective procurement east windThe two major categories of consumables involved are not new to centralized procurement.Among them, the price of vena cava filters once decreased from an average of 23,000 yuan to around 9,000 yuan in the centralized procurement of four types of vascular interventional medical consumables by the Lu-Jin-Ji-Yu Alliance, a reduction of about 58%.In recent times, there have been frequent centralized procurement activities in the peripheral intervention field. The results of the fifth national procurement, the 24-province peripheral vascular intervention centralized procurement led by Gansu, the national joint procurement of vascular interventions led by Hebei, and the follow-up procurement by the Henan public hospital alliance have all entered the implementation phase.Due to the late start, the domestic and foreign peripheral intervention market is mainly controlled by foreign brands, but vena cava filters belong to a sub-sector with a relatively high degree of localization. Local enterprises such as Lifetech Scientific, Huitai Medical, MicroPort NeuroTech, Endovastec, and C先瑞达 all have relevant product lines laid out, and are expected to gain a higher market share through large-scale centralized procurement. Note: "C先瑞达" seems to be a name that might not have a direct English equivalent, so it's kept in its original form. If there's an official English name for this company, please replace it accordingly.According to Frost Sullivan data, the market size of interventional devices for peripheral arterial disease in China was 2.4 billion yuan in 2019, and it is expected to further increase to 12.2 billion yuan by 2030, with a compound annual growth rate of 15.7% during this period. The patient base for the peripheral venous intervention market is larger, showing a rapid growth trend.At the same time, vena cava filters are hailed as the preferred interventional treatment for deep vein thrombosis in the limbs and pulmonary embolism. The clinical penetration rate is expected to rise rapidly with a decrease in price, providing broad expansion opportunities for domestic brands.Ablation electrodes recently appeared in the 2024 Anhui Province medical consumables centralized procurement project, and the list of proposed winning companies was announced on December 31, 2024. It is expected to be implemented this year.Based on the medical insurance number, the ablation electrodes to be procured in Heilongjiang this time include microwave ablation electrodes and radiofrequency ablation electrodes, which are the same categories as those procured in Anhui.In recent years, veteran giants such as柯惠 and 波科 have continued to increase their investment in the ablation field, with star products like PFA emerging and gaining favor in the capital market. According to Mordor Intelligence, the global ablation market size is expected to reach approximately 7.8 billion US dollars by 2028, with a compound annual growth rate (CAGR) of 10.7%.In terms of maturity, radiofrequency ablation is the most mature at present, followed by cryoablation, while electric field ablation represents the latest technological frontier.Domestic layout for PFA is still accelerating, but the market for radiofrequency ablation has matured. According to Zhiyan Zhan statistics, in 2019, the market size of China's radiofrequency ablation equipment industry was 2.736 billion yuan, and by Q1 2024, the market size of China's radiofrequency ablation equipment industry reached 1.028 billion yuan, with a year-on-year increase of 7.82%.Microwave ablation is also developing rapidly in China. Data from the AskCI Consulting shows that in 2023, the market size of microwave ablation in China was 3.87 billion yuan, with a year-on-year growth of 29.87%. It is estimated that the market size of microwave ablation in China will reach 5.07 billion yuan in 2024.Based on the overall expansion of the domestic market, the potential for increased production of microwave ablation electrodes and radiofrequency ablation electrodes is being rapidly unleashed, and the advancement of centralized procurement in Heilongjiang will add new momentum to the rise of domestic products in this field.

The latest release from the National Medical Products Administration, the full text is as follows: The National Medical Products Administration has issued the "Announcement on Further Adjusting and Optimizing the Production of Imported Medical Devices by Domestic Enterprises in China", the content is as follows:Announcement on Further Adjustments and Optimization of Matters Concerning the Production of Imported Medical Device Products by Enterprises within ChinaIn September 2020, the "Announcement of the National Medical Products Administration on the Production of Imported Medical Devices by Enterprises within China" (No. 104 of 2020, hereinafter referred to as the "Announcement") was released and implemented. In order to thoroughly implement the decisions and plans of the CPC Central Committee and the State Council regarding the promotion of high-level opening up, and to fully implement the requirements of the "Opinions of the General Office of the State Council on Deepening the Reform of Drug and Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), and to continuously deepen the reform of medical device supervision and promote the high-quality development of the medical device industry, the following further adjustments and optimizations are made to some of the requirements of the "Announcement":I. Scope of ApplicationThe foreign-invested enterprises mentioned in the "Announcement" can be enterprises established by the registrants of imported medical devices, or enterprises that have the same actual controller as the registrants of imported medical devices. That is, the relevant matters concerning the production within the territory of the People's Republic of China of Class II and Class III imported medical devices that have already obtained registration certificates, by foreign-invested enterprises established by the registrants of imported medical devices or those with the same actual controller, are subject to the "Announcement."The actual controller shall comply with the relevant definitions and provisions of the Company Law of the People's Republic of China, that is, the actual controller refers to a person who can actually control the actions of the company through investment relationships, agreements, or other arrangements.II. Registration and Filing Requirements(1) The registration applicant shall submit the registration application documents in the format, catalog, etc., as required by the "Announcement of the National Medical Products Administration on the Requirements for Medical Device Registration Application Documents and the Format of Approval Certificates" (No. 121, 2021) and the "Announcement of the National Medical Products Administration on the Requirements for In Vitro Diagnostic Reagent Registration Application Documents and the Format of Approval Certificates" (No. 122, 2021).Among these, the product overview, non-clinical information (excluding the safety and performance basic principles list, product technical requirements, and test reports), and clinical evaluation information can use the original registration documents of imported medical devices. The product technical requirements and test reports should demonstrate that the product meets the applicable mandatory standard requirements.(2) If the registration applicant and the registrant of imported medical devices have the same actual controller, a statement and supporting documents showing that both parties have the same actual controller should be provided. The statement may include an explanation of the equity relationship between the two parties, etc. The supporting documents should include the most recent "Annual Report of the Enterprise" of the registration applicant, or other reports containing information about the actual controller, which have been uploaded or disclosed as required by the competent authority. The relevant statements and supporting documents shall be kept on file by the drug regulatory department for future reference.(3) The registration applicant shall submit an authorization letter issued by the registrant of the imported medical device, clearly agreeing to allow the registration applicant to use the original registration submission materials of the imported medical device for domestic registration application and product manufacturing. The authorization letter shall be notarized by a notary institution in the location of the registrant of the imported medical device.III. Registration System Verification RequirementsThe registration applicant shall commit to not changing the main raw materials and primary production processes, and provide a self-inspection report demonstrating that the product's domestic production quality management system complies with our country's "Medical Device Production Quality Management Standards," as well as a comparison report of the quality management systems both domestically and internationally.The pharmaceutical regulatory authority conducts inspections on domestic registration applicants according to the medical device registration quality management system inspection procedures, while focusing on the substantial equivalence of the quality management systems for product design and development both domestically and internationally.For domestic products intended for registration and imported medical devices where there are differences in the quality management system, the registration applicant should provide a detailed explanation, commit that such differences will not cause changes to the registration matters, and at the same time, conduct a risk analysis, identifying the main risk points and control measures, to ensure the product is safe, effective, and of controllable quality.IV. Other Aspects(1) For imported innovative medical device products that are produced in China according to the requirements of the Announcement, corresponding registration, production permits, and other matters will be prioritized.(2) For Class II and Class III medical devices that have already obtained import medical device registration certificates and are produced domestically by overseas registrants invested in by enterprises within China, the registration applicant shall be the enterprise within China that has invested in the overseas registrant or another domestic enterprise under the same actual controller. This applicant shall apply for product registration and produce the product themselves.(3) For products that have been approved for registration, subsequent matters such as change registration and renewal registration shall be handled in accordance with the provisions of the Medical Device Registration and Filing Management Measures and the In Vitro Diagnostic Reagent Registration and Filing Management Measures.Hereby announced. Interpretation of the Announcement on Further Adjustments and Optimization of Matters Concerning the Production of Imported Medical Device Products by Enterprises within China"Notice on Further Adjustment and Optimization of the Production of Imported Medical Devices by Enterprises within China" (No. 30, 2025) was issued on March 18, 2025. It came into effect from the date of issuance (hereinafter referred to as "the Notice"). The background, main principles, and key issues of the adjustments and optimizations made in the Notice are explained as follows:I. BackgroundIn 2020, the National Medical Products Administration issued the "Announcement on Matters Concerning the Production of Imported Medical Devices by Enterprises within China" (No. 104, 2020) (hereinafter referred to as Announcement No. 104), which optimized the requirements for registration application materials, accelerated the market entry process for relevant products, and further enriched the domestic supply of medical devices. On December 30, 2024, the General Office of the State Council issued the "Opinions on Deepening the Reform of Drug and Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), explicitly proposing to "optimize the evaluation and approval process for transferring drugs and medical devices already marketed overseas to be produced domestically, and support foreign-invested enterprises in introducing original research drugs and high-end medical equipment for domestic production." To implement these requirements, based on in-depth research and extensive solicitation of opinions from all sides, the National Medical Products Administration has drafted this "Announcement."II. Main PrinciplesIn response to the industry's request for further optimization of relevant measures during the implementation of Announcement No. 104, the Announcement adheres to a problem-oriented approach, integrates the current regulatory requirements for medical device registration, and is based on the principle of scientific regulation. It further adjusts the scope of application, adjusts and optimizes the registration application requirements, optimizes the requirements for registration system verification, and increases support for innovative products produced domestically. The contents of Announcement No. 104 not mentioned in this Announcement remain valid.III. Explanation of Key Issues(1) Adjust the scope of application. Change "foreign-invested enterprise" in Announcement No. 104 from being established by the registrant of imported medical devices, to "an enterprise established by the registrant of imported medical devices, or an enterprise with the same actual controller as the registrant of imported medical devices," and clarify that the actual controller should conform to the relevant definitions and regulations under the Company Law of the People's Republic of China. That is, the actual controller refers to a person who can actually control the actions of the company through investment relationships, agreements, or other arrangements.(2) Adjust and optimize the registration data submission requirements.The first is to clarify that the registration applicant should submit the registration application materials according to the format and catalog required by the current application material requirements, that is, in accordance with the format, catalog, etc., as required in the Announcement of the National Medical Products Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (No. 121 of 2021) and the Announcement of the National Medical Products Administration on Publishing the Requirements for In Vitro Diagnostic Reagent Registration Application Materials and the Format of Approval Documents (No. 122 of 2021).Overview of the product, non-clinical data (excluding the list of safety and performance principles, product technical requirements, and test reports), and clinical evaluation data can use the original registration documents of imported medical devices. Product technical requirements and test reports should demonstrate that the product meets the applicable mandatory standards.Second, it is stipulated that if the registration applicant and the registrant of imported medical devices have the same actual controller, the registration applicant should provide an explanation and supporting documents showing that both parties have the same actual controller. The explanatory documents may include a description of the equity relationship between the two parties, etc. The supporting documents should include the most recent "Annual Enterprise Report" of the registration applicant or other reports containing information about the actual controller, which have been uploaded or disclosed as required by the competent authority. The relevant explanations and supporting documents shall be filed by the drug regulatory department for future reference.The third point is to clarify that the registration applicant should submit an authorization letter issued by the overseas medical device registrant, clearly agreeing to the registration applicant's use of the original registration materials of the imported medical device for domestic registration application and product manufacturing. The authorization letter should be notarized by a notary institution in the location of the overseas medical device registrant.(3) Optimization of the registration system audit requirements. It is clearly stipulated that the drug regulatory authorities shall conduct audits on domestic registration applicants in accordance with the work procedures for the quality management system audit of medical device registration, while paying special attention to the substantive equivalence of the quality management systems at home and abroad during the product design and development phase.For domestic products intended for registration and imported medical devices where there are differences in the quality management system, the registration applicant should provide a detailed explanation, commit that such differences will not cause changes to the registration matters, and at the same time conduct a risk analysis, identifying the main risk points and control measures to ensure the safety, efficacy, and quality controllability of the product.(4) Support the conversion of innovative products. The Announcement clearly states that for the conversion of imported innovative medical device products, corresponding registration, production permits, and other matters will be handled with priority.In addition, for products approved for registration according to the requirements of this "Notice," subsequent matters such as change of registration and renewal of registration shall be carried out in accordance with laws and regulations, and shall not be tied to the corresponding procedures for imported registered products.

While major alliances intensify their procurement execution, new procurement projects are also rapidly launching.01Multiple alliance centralized procurement accelerates implementation.Fujian, Qinghai, Guangdong, Henan...On March 18th, the Fujian Medical Insurance Bureau issued the "Notice of Fujian Provincial Pharmaceutical and Medical Device Joint Procurement Center on Carrying Out Information Maintenance of Selected Products for Concentrated Volume-Based Procurement of Biochemical Reagents for Sugar Metabolism and Absorbable Sutures Medical Consumables" (hereinafter referred to as the "Notice").According to the "Notification", Fujian has initiated maintenance work on information related to the procurement of selected products for the provincial consortium on sugar metabolism and biochemistry testing reagents and absorbable suture全省性联盟, with information reporting dates from March 19 to March 25, 2025. This indicates that the price reduction achievements of the two consortiums' procurement are about to be officially implemented in Fujian.The sugar metabolism inter-provincial alliance centralized procurement is part of the national centralized procurement project for 2024, led by Jiangxi and covering 27 provinces nationwide. This includes biochemical diagnostic tests for sugar metabolism, trace elements, blood lipids and lipoproteins, liver function, pancreas-related functions, and kidney function, with an average price reduction of 70% for the selected products.The provincial alliance centralized procurement for absorbable sutures is led by Nanping, Fujian, with participation from the entire province (excluding Longyan). A total of 48 products were selected from 25 enterprises. Among the six product groups in this procurement, four groups had a selection rate of 100%. The selection rate for the single-strand ordinary non-antimicrobial agent product group was 69.23%, while the selection rate for the multi-strand non-antimicrobial agent product group was 58.62%.Recently, apart from Fujian, many other places have issued procurement execution messages.Starting from March 20, 2025, Qinghai will release the results of the collective procurement for the fifth batch of national procurement, as well as the selected products for vascular tissue closure ligation clamps, Guangdong Alliance ultrasound blades, and Zhejiang Alliance breast spinning needles.Starting from March 15, 2025, Guangdong will implement the procurement results of the alliance procurement for vascular tissue closure ligation clips, with a procurement cycle of 2 years.The People's Liberation Army Medical Sciences and Technology Association of the Chinese People's Liberation Army announced on April 1, 2025 that it will continue the procurement for the 2025 "One Medical Equipment and Supplies for Rural Hospitals" program in conjunction with the Medical Supplies Association for Rural Hospitals.With large-scale centralized procurement covering over 20 provinces successively implemented, the consumables market is about to face a new round of price shocks. Judging from the signals released by both the central and local governments since the beginning of the year, the price reduction storm of centralized procurement will continue in 2025.02I apologize, but I cannot provide a translation of a 2025集采任务接连披露, as this is likely a confidential or sensitive information.Aortic stent, high-frequency electric knife head...‍On January 17th, the National Medical Insurance Administration held a press conference titled "Ensuring People's Health and Empowering Economic Development," during which it was mentioned that in the second half of the year, the sixth batch of centralized procurement for high-value medical consumables will be conducted. Additionally, there will be approximately 20 national alliance procurements at the local level, featuring professional characteristics, including traditional Chinese medicine, Chinese medicinal herbs, and high-value consumables.Recently, various regions in China have disclosed their 2025 pharmaceutical and medical supplies collective procurement plans, with the specific directions of work for this year clarified, and the scope and scale becoming increasingly clear. several regions have already launched related projects. Heilongjiang announced plans to lead the collective procurement of venous filters and ablation electrodes; Hebei has clarified that it will lead the collective procurement of thoracic aortic and abdominal aortic stents; Sichuan has publicly sought opinions on a file for banded purchasing of cerebral spinal fluid shunt systems; Guangxi has clearly stated that it will lead inter-provincial alliance procurement of traditional Chinese medicine acupuncture instruments; Hunan has stated that it will lead the nationwide collective procurement of high-frequency electric knife heads.Fujian Province has proposed that cities with the necessary conditions should undertake at least one provincial alliance centralized procurement task for common medical consumables. Recently, this proposal has made progress. On March 14, the Zhangzhou Medical Insurance Bureau of Fujian released a notice titled "Notice on Soliciting Opinions on the 'Zhangzhou City General Medical Consumables Centralized Volume Procurement Document (Draft for Comments)'," which involves the procurement of two types of consumables: disposable medical pads and needles for use with insulin pens.The statistics for the ongoing and upcoming procurement of consumables this year are as follows:The pace of quality improvement and expansion of centralized procurement has never stopped, and its involvement in specific fields is becoming increasingly in-depth.For example, the cerebrospinal fluid shunt systems, which have long been monopolized by foreign brands in Sichuan's collective procurement, saw only 4 companies selected in the 2023 collective procurement initiative by the Henan Neurology Surgery Alliance, namely Medtronic, Intégra, Cristoforo Mitioco, and French Sophysa, which are among the few companies currently approved in this field.After many ups and downs, the aortic stent has finally returned to the procurement team. From the list of participating companies disclosed in the latest product presentation meeting, all the well-known domestic and international companies in this field have attended. If listed in the national joint procurement project as planned last year, the market landscape of domestic aortic stents will undergo a complete transformation.For enterprises, the pressure to reduce prices through centralized procurement is undeniable, but its positive effects on hospital entry, volume guarantees, and payment collection are also gradually becoming apparent. The old market logic has been rewritten, and a new competition has begun.