(2) separately
1. To accept the situation in the third class medical device registration
In 2016, accepts the third class medical device registration within the territory of a total of 3007, compared with 2015 decreased by 23%. Among them, 1899 items for medical device registration, for in vitro diagnostic reagents registration 1108 items.
From the registration form, registration for the first time in 864 total 29% of the class iii medical devices registration number, continuation of registered 1622 accounted for 54% of the total number of application for registration, licensing items change 521 accounted for 17% of the total number of registration. Registration form of distribution as shown in figure 2.
In figure 2. The third distribution registration application for registration form
2. Import the second category of medical device registration to accept the situation
In 2016, the import to accept the second category of medical device registration, a total of 3095, compared with 2015 increased by 2%. Medical device registration for item 1690, 1405 items for in vitro diagnostic reagents registration.
From the registration form for the first time registered 449 total imports 15% of the second category of medical equipment registration number, continuation of registered 2021 accounted for 65% of the total number of application for registration, licensing items change 625 accounted for 20% of the total number of registration. Registration form of distribution as shown in figure 3.
Figure 3. Import profile for the second category of registration registration form
3. The imported class iii medical devices registered to accept the situation
In 2016, import a total of 2818 items, the third class medical device registration is increased by 15% compared with 2015. Medical device registration for item 2331, 487 items for in vitro diagnostic reagents registration.
From the registration form for the first time registered 299 total imports 11% of the class iii medical devices registration number, continuation of registered 1759 accounted for 63% of the total number of application for registration, licensing items change 760 accounted for 16% of the total number of registration. Registration form of distribution as shown in figure 4.
Figure 4. Imports for the third class registration registration form distribution
Three, review of medical device registration approval
In 2016, the food and drug supervision bureau were done for medical device registration technology review, 9336 compared with 2015 growth of 0.25%. Among them, the first registered 2427, registered 5276, licensing items change to 1633. By the end of 2016, is in a state in the review application, a total of 5598, among them, 2247 is in a state issued a notice of supplementary material to make up for.
In 2016, the food and drug supervision bureau had approved medical device registration, the continuation of registration and licensing issues the registered item 8653. Compared with 2015 registered a 14.9% increase in the number of total approval.
Food and drug supervision bureau in 2016, a total of 2016 item of medical device registration application shall be rejected for registration and enterprise to withdraw 310 items.
Nearly four years administration approved medical device registration situation as shown in figure 5.
Figure 5.2013-2016 registration data
(a) the overall situation
Approved in 2016, the administration in 2902, the third class medical device registration is increased by 6% compared with 2015, 5751 items imported medical instruments, compared with 2015 increased by 20%.
5506 items in accordance with the registered variety distinguish, medical apparatus and instruments, in vitro diagnostic reagent, 3147, the proportion is about 17.
According to the registration form, type registered 1966 accounted for 23% of the total registered for the first time last registered 5221 accounted for 60% of all applications for registration, licensing items change registered 1466 accounted for 17% of the total application for registration. Registration form proportion is as shown in figure 6.
Figure 6.2016 years registration form scale map
(2) separately
1. In the third class medical apparatus and instruments for examination and approval of the review
2902 2016 in the third class medical device registration. 1661 items of medical apparatus and instruments, in vitro diagnostic reagent, 1241 items.
From the registration form, registration for the first time in 929 total 32% of the class iii medical devices registration number, continuation of registered 1510 accounted for 52% of the total number of application for registration, licensing items change 463 accounted for 16% of the total number of registration. Registration form of distribution as shown in figure 7.
In figure 7. Distribution of class iii medical devices registration form
2. Import the second category of medical apparatus and instruments for examination and approval of the review
In 2016, imported 3083 the second category of medical device registration. Among them, 1535 medical device registration, in vitro diagnostic reagents registered 1548 items.
From the registration form for the first time registered 444 total imports 14% of the second category of medical equipment registration number, continuation of registered 2077 accounted for 68% of the total number of application for registration, licensing items change 562 accounted for 18% of the total number of registration. Registration form of distribution as shown in figure 8.
Figure 8. Import of distribution of the second category of medical device registration form
3. The imported class iii medical devices for examination and approval of the review
In 2016, imported 2668 third class medical device registration. Among them, 2255 medical device registration, in vitro diagnostic reagents registered 413 items.
From the registration form for the first time registered 593 total imports 22% of the second category of medical equipment registration number, continuation of registered 1634 accounted for 61% of the total number of application for registration, licensing items change 441 accounted for 17% of the total number of registration. Registration form of distribution as shown in figure 9.
Figure 9. Import distribution of class iii medical devices registration form
(3) the first monthly examination and approval for the registration project
Approved in the food and drug supervision bureau, 2016 registered medical device for the first time a total of 1966 for the first time for examination and approval of monthly case shown in figure 10.
Figure 10.2016 annual monthly approval registered medical device data graph for the first time
|
