Five, the other registration management
(a) in the second category of medical device registration
In 2016, the provincial food and drug regulatory authorities had approved in 15553, the second category of medical device registration compared with 2015 growth of 26.4%. 5854 items of registration for the first time, continue to register 5885, licensing item changes its registered 3814 items.
In the second category of medical apparatus and instruments of register is shown in figure 16.
Figure 16. In the second category of medical device registration form scale map
From the registration situation, Beijing, guangdong, jiangsu, zhejiang, shandong, Shanghai, henan seven provinces (municipalities directly under the central government) of the large number of the second category of medical devices within the territory of registration. The second category of medical device registration specific data as shown in the following table and figure 17.
Figure 17. The provinces in the second category of medical device registration data
(2) class I medical devices for the record
In 2016, the food and drug supervision administration of class I medical devices shall be in accordance with the duties were imported for the record number of 2511, compared with 2015 growth of 0.9%.
Districts of the country's municipal food and drug regulatory authorities in accordance with the duties were within the territory of class I medical devices for the record number of 11463, a fall of 15.2% compared with 2015.
(3) the registered items change
In 2016, the food and drug supervision bureau in accordance with the duties were imported in the second, three, and the third class medical device registration items change to 7082. Compared with 2015 growth of 51%.
Among them, the class iii medical devices within the territory of 2636 items of the registered items change, the second, three types of medical equipment import the registered items change, 4446 items.
Provincial food and drug regulatory authorities in accordance with the duties were the second category of medical devices within the territory of 7322 items of the registered items change, compared with 2015 growth of 39.3%.
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