On April 8th, at the 91st China International Medical Equipment (Spring) Expo (CMEF), the international independent third-party testing, inspection, and certification organization TÜV Rheinland Greater China (referred to as "TÜV Rheinland") awarded Yinkang Life's Haier Biomedical medical low-temperature preservation box and blood refrigerator two types of products with the notified body certificate based on the EU Medical Device Regulation (Regulation(EU)2017/745, referred to as MDR). This is also the global first medical low-temperature storage equipment product MDR notified body certificate issued by TÜV Rheinland. Haier Biomedical General Manager Liu Zhanjie, TÜV Rheinland Greater China Medical Device Service Vice President Geng Wen and other representatives from both sides attended the certificate awarding event.

Haier Biomedical has been awarded the world's first EU MDR certificate for medical low-temperature storage equipment.

The acquisition of the EU MDR certificate signifies that Haier Biomedical's medical refrigeration storage equipment-related products have met international standards in terms of safety, efficacy, and lifecycle management. This not only fulfills the latest entry requirements for the EU market but will also expedite the registration process in regions such as Southeast Asia, the Middle East, and Africa. Currently, Haier Biomedical has accelerated its advancement into a new stage of its international strategy, setting a new benchmark for high-quality overseas expansion in the medical device industry.

Obtained EU MDR certification, quality and technical standards in line with international standards

Medical low-temperature storage equipment is specialized equipment used for storing tissues, cells, vaccines, blood, and blood products. In recent years, with the development of life sciences and biotechnology, there has been an increasing demand for precise and professional storage equipment, driving continuous growth in the medical low-temperature storage market. MDR compliance certification is a requirement for medical device products to enter the EU market, imposing higher requirements on product performance safety, pre-market clinical evaluation, clinical data collection, and post-market market surveillance, vigilance systems, and regulation.

As the industry leader, Haier Biomedical has ( scientific and technological independent innovation) since its inception. As early as 2006, it independently broke through the key core technologies in the field of biological medical low-temperature refrigeration, achieving the localization of such equipment, and was awarded the Second Prize of National Science and Technology Progress in 2013. At the same time, to enhance industrial standard levels, Haier Biomedical took the lead in formulating China's first national standard for low-temperature storage boxes and is currently taking the lead in advancing the first IEC international standard project for medical low-temperature storage boxes, thus forging a path from technological breakthroughs to standard leadership. TÜV Rheinland Group is an internationally renowned third-party inspection, testing, and certification institution with strong professional testing capabilities and rich international certification experience in the medical device sector. Products that pass TÜV Rheinland certification represent high quality and reliability. Note: There was a segment in Chinese characters that did not translate seamlessly into English due to a potential typo or formatting issue. The direct translation of "" is included in parentheses for clarity.

In this case, where there were no precedents for domestic medical refrigeration equipment receiving EU MDR certification, Haier Biomedical completed all necessary preparations including product testing, software assessment, cybersecurity testing and review, usability review, clinical evaluation, and MDR quality system construction. They successfully passed the EU MDR audit. It is understood that medical devices with EU MDR certification can simplify registration processes in other overseas markets such as Southeast Asia, the Middle East, and Africa due to their international recognition, reducing duplicate tests and documentation, thereby significantly accelerating relevant registration processes and helping companies quickly enter emerging markets. Liu Zhuanjie, General Manager of Haier Biomedical, stated that the EU MDR certificate is a significant manifestation of Haier Biomedical's commitment to technological innovation and quality-first principles. It plays a crucial role in accelerating the high-quality globalization of their "product + solution." Taking this opportunity, Haier Biomedical will provide high-quality solutions to medical institutions and research units in more countries, promoting the high-quality development of domestic medical devices in the international market, and contributing Chinese wisdom and strength to the construction of a global health community.

Geng Wen, Vice President of TÜV Rheinland Greater China Medical Device Services, stated that the two products, medical low-temperature preservation boxes and blood refrigeration boxes, have passed the EU MDR certification. This not only highlights the technical strength of Haier Biomedical but also signifies a crucial step for Chinese intelligent manufacturing in the field of high-end medical equipment. Looking ahead, TÜV Rheinland will continue to coordinate global professional resources to promote China's outstanding medical device products and related technologies to go global and enter the EU market in a fast and compliant manner. At the same time, TÜV Rheinland is willing to work together with Haier Biomedical to create a better future for the medical device industry!

Promoting internationalization through localization, creating a new paradigm of "product + solution" for overseas markets.

Receiving the world's first medical low-temperature storage equipment EU MDR certificate is just a microcosm of Haier Biomedical's international innovation layout. In the wave of globalization, product certification is a crucial step in ensuring product quality and compliance, and it's also the "key" to entering the international market. Facing various product certification requirements from different countries and regions, Haier Biomedical strictly follows the relevant laws and regulations while adhering to independent innovation, committed to accelerating the pace of "product + solution" through high technology and high standards. With leading technical strength and excellent product performance, by the end of 2024, Haier Biomedical has accumulated more than 400 model products that have obtained overseas certification, including more than 200 EU CE certifications, more than 70 US FDA certifications, more than 140 US UL certifications, and 12 US AABB certifications.

In the journey of going global, a stable and deep approach requires not only the "hard support" of technological innovation but also the continuous enhancement of the "soft power" of international operations by enterprises. With an international perspective, Haier Biomedical is continuously building a global market system that directly faces users, improving the interaction, customization, and delivery capabilities of scenario solutions. By promoting localized strategies of "one country, one policy," Haier Biomedical actively enhances regional delivery capabilities and establishes a local service response mechanism. By constructing localized operation centers that cover local products, marketing, logistics, and after-sales, the company achieves rapid insight and response to local user needs, upgrading the overseas model from "product output" to "ecosystem co-building."

Currently, Hai'er Biomedical has established long-term cooperative relationships with nearly 80 international organizations such as the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF). Its products and solutions have been applied in more than 150 countries and regions worldwide, contributing to the construction of a global community of health and wellness.

At CMEF, Haier Biomedical was awarded the world's first MDR certificate for medical low-temperature storage equipment, which is just one of the dazzling footnotes in the journey of Chinese medical device companies going global. Currently, going global has become a new engine for Chinese medical device companies to create a second growth curve and is also a necessary path for leading brands to internationalize and globalize. Looking to the future, Haier Biomedical will continue to focus on user needs, further strengthen technological innovation capabilities, and adhere to the concurrent implementation of localization and internationalization strategies, making high-quality going global more stable and broader, injecting strong vitality into the progress and development of global life science and medical services, promoting global medical inclusiveness, and making life better!