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National Medical Products Administration issued a document

Accelerating the review and approval of medical devices

Today (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 R&D, 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.

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2025, Innovative Equipment Supports Full Chain Upgrade

The "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.