CFDA announces statistical report on medical devices in the first quarter of 2021

Ⅰ.Administrative acceptance of medical devices

A total of 7,453 Class I medical devices  registered nationwide, among which 189 are imported Class I medical devices.A total of 4123 applications for first registration  have been  accepted throughout the country, including 3560 first registered medical devices of the second category, 377 first registered medical devices of the third category, and 186 imported first registered medical devices (including Hong Kong, Macao and Taiwan).A total of 3862 applications for renewal registration  have been accepted nationwide, including 2460 domestic applications for category II medical devices, 516 domestic applications for category III medical devices and 886 applications for imported medical devices (including Hong Kong, Macao and Taiwan).

Ⅱ.Registration of medical device products

A total of 3358 medical devices of all kinds have been approved for the first time and 4380 have been renewed.

Among them, 3,028 pieces of Category II medical devices have been first registered, 228 pieces of Category III medical devices have been first registered, and 102 pieces of imported medical devices (including Hong Kong, Macao and Taiwan) ave been first registered.A total of 2739 category II domestic medical devices, 619 category III domestic medical devices and 1022 imported medical devices (including Hong Kong, Macao and Taiwan) have been approved for renewal registration.

By the end of March 2021, a total of 103962 category I domestic medical devices have been filed, and a total of 70651 category II medical devices  have been approved by provincial bureaus.

Ⅲ.Basic situation of medical device manufacturing enterprises

By the end of March 2021, there were 26800 medical device manufacturing enterprises in China, including 15500 enterprises that can produce first-class products, 13300 enterprises that can produce second-class products, and 2097 enterprises that can produce third-class products.

Ⅳ.Basic situation of medical device business enterprises

By the end of March 2021, there are 939900 enterprises operating category II and III medical devices in China, of which 623900are engaged in category II medical device products, 76600 in category III medical device products, and 239400 in category II and category III medical device business at the same time.There are 776 enterprises that provide third-party platform services for medical device network trading services.

Ⅴ.Investigation and handling of medical device cases

During the reporting period, a total of 3606 medical device cases have been investigated and dealt with nationwide, with a total value of 100.6513 million yuan. A fine of 81.2798 million yuan has been imposed, illegal gains of 4.4272 million yuan have been confiscated, 12 unlicensed operators have been banned, 4 fake manufacturing and selling sites have been destroyed, 9 production and business suspensions (including 2 production enterprises and 7 operating enterprises) have been ordered, and 11 cases have been transferred to judicial organs.

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