On November 14, the State Food and Drug Administration approved the application for registration of artificial bone repair materials submitted by Wuhan Asia Biological Materials Co., Ltd. (hereinafter referred to as 'Wuhan Asia Biological'), which is the first multi-level structure artificial bone repair material medical device with artificial biological activity approved for listing in China. Its large-scale clinical use will play a leading role in the high-quality development of the high-end medical device industry in the province.

Biomedical materials have important layout in the '13th Five-Year Plan' and '14th Five-Year Plan' national major scientific and technological plans. The market share of biomedical materials products in China accounts for 46% of the trillions of medical devices. The clinical demand for orthopedic biomaterials is large, accounting for 37.5% of the global biomaterials market, and the market share ranks first among biomaterials. At present, more than 70% of high-end biomaterials and instruments rely on foreign imports. Especially in November 2018, the United States Department of Commerce listed biomaterials in 14 export control frameworks to restrict exports to China, which greatly increased the risk of 'people's life and health' being independently controlled. The scientific transformation team of biomaterials and medical device supervision of Huazhong University of Science and Technology has carried out long-term cooperation with Wuhan Asia Biology. During the '13th Five-Year Plan' and '14th Five-Year Plan', many international innovative products have been listed in the national key research and development plan and major strategic products have been supported. The Hubei Provincial Drug Administration actively recommended the team to participate in the research of the national medical device regulatory scientific project. With the strong support of Wang Zhonglin, Zhang Wenbing, Zhao Haishan and other provincial leaders, the team passed the investigation and evaluation of the State Drug Administration last year. At the beginning of this year, the State Drug Administration approved Huazhong University of Science and Technology to build a 'scientific research base for medical device supervision'. The artificial bone repair materials and instruments approved for the market this time are the research and transformation achievements of the base.

Recently, the base, together with Wuhan University, Wuhan Textile University, Wuhan University of Technology and Peking University Stomatological Hospital, and other units, jointly established and put into operation the 'Institute of Biomedical Materials of Wuhan Institute of Industrial Development and Innovation'. It is expected that in the next 3-5 years, 5-6 major biomaterial products will be promoted to obtain the Class III medical device registration certificate of the State Food and Drug Administration, and a 'unicorn' company will be incubated to register in the scientific innovation version.

In the next step, the Hubei Provincial Drug Administration will continue to support the construction of the scientific research base for medical device supervision of Huazhong University of Science and Technology, and strive to register and list more high-end innovative medical device products and settle in Hubei Province.

(From China Food and Drug Network)