Pilot Medical Device Registrant System in Shanghai Free Trade area

  • 2017-12-12
Following the first pilot of the System of the Holders of Drug Marketing Licenses, on the 7th day of this month, Shanghai Municipal Food and Drug Administration issued and carried out the Implementing Measures for Pilot Program of Medical Devices Registrant System in China (Shanghai) Pilot Free Trade Zone, and conducted the first pilot medical device Registrant system innovation and reform.

After pilot launch, the qualified registration applicants of medical devices can individually apply for registration license and then entrust the license to qualified and productive manufacturers to “untie” the product registration from production license and facilitate the launch of innovative products. In the past, the registration and production of medical devices of China was tied together and must be completed by a market player. The “tied” mode affected the passion of enterprises to make innovation and development and continuously improve product quality, limited the reasonable allocation of innovation elements and violated against the legislative spirits of international rules and Regulations on the Supervision and Administration of Medical Devices of China.

As introduced, after implementing reform, the registrant can entrust multiple manufacturers for production so as to greatly reduce the pre-market innovation cost of products and ensure product quality by rational division of labor. According to Xu Lai, the deputy chief of Shanghai Municipal Food and Drug Administration, the excess production capacity of medical devices industry in China has gradually become a prominent problem, and many manufacturers were prevented from entering into the market and releasing the whole capacity due to their failure to obtain registration license or lack of production qualification. By “untying” the systems, this form expected to facilitate the specialized division of labor in medical devices market and reasonably allocate production resources so as to form a benign interaction cycle. “Compared to previous systems, this reform at least added 3 limitations on supervision.” According to the introduction of Lin Sensong, the Director of medical devices supervision department of Shanghai Municipal Food and Drug Administration, first, Shanghai will stick to more strict standards in the approval link to fully prevent low-end OEM manufacturers being included in the pilot scope; second, post-market surveillance of medical devices will be strengthened and the frequency and intensity shall be increased for enterprises graded as high-risk; third, regional coordination and regulation shall be intensified.