Acceptance status of NMPA medical device registration application in 2023
In 2023, the NMPA accepted a total of 13,260 applications for the first registration, extension registration and change registration of medical devices in accordance with its responsibilities, an increase of 25.4% compared with 2022.
I. Overall situation
It accepted 7,106 domestic applications for the registration of Class III medical devices and 6,154 applications for the registration of imported medical devices. According to the registered varieties, there were 9,968 applications for the registration of medical devices and 3,292 applications for the registration of in vitro diagnostic reagents. According to the registration form, there were 3,559 initial registration applications, accounting for 27% of all medical device registration applications; There were 4,676 extended registration applications, accounting for 35% of all medical device registration applications; There were 5,025 applications for registration changes, accounting for 38% of all medical device registration applications. The ratio of registration form to number is shown in Figure 1.
FIG. 1 Proportion diagram of the form and quantity of NMPA registration accepted projects
II. Itemized information
i. Acceptance of domestic Class III medical device registration
A total of 7,106 domestic Class III medical device registrations were accepted , an increase of 31% compared with 2022. Among them, there were 5,432 applications for registration of medical devices and 1,674 applications for registration of in-vitro diagnostic reagents.
Figure 2. Distribution of domestic registration forms of Category III medical device registration acceptance items
From the perspective of registration forms, 2860 items were registered for the first time, accounting for 40.2% of the total number of applications for the registration of Class III medical devices ; 1,914 extended registrations, accounting for 26.9% of the total number of domestic applications for the registration of Class III medical devices; There were 2,332 changes in registration, accounting for 32.8% of the total number of applications for the registration of Class III medical devices in China. The distribution of registration forms is shown in Figure 2.
ii. Acceptance of registration of imported Category II medical devices
A total of 3,036 imported Category II medical device registrations were accepted, an increase of 23.1% compared with 2022. Among them, there were 1,723 applications for registration of medical devices and 1,313 applications for registration of in-vitro diagnostic reagents. From the perspective of registration forms, 300 items were registered for the first time, accounting for 9.9% of the total number of imported Class II medical device registration applications; Continued registration of 1,631 items, accounting for 53.7% of the total number of imported Class II medical device registration applications; 1,105 changes were registered, accounting for 36.4% of the total number of imported Class II medical device registration applications. The distribution of registration forms is shown in Figure 3.
FIG. 3 Distribution of registration forms of imported Category II medical device registration acceptance items
iii. Acceptance of registration of imported Class III medical devices
A total of 3,118 imported Class III medical device registrations were accepted, an increase of 16.4% compared with 2022. Among them, there were 2,813 applications for registration of medical devices and 305 applications for registration of in-vitro diagnostic reagents. From the perspective of registration forms, 399 items were registered for the first time, accounting for 12.8% of the total number of imported Class III medical device registration applications; 1,131 continued registrations, accounting for 36.3% of the total number of imported Class III medical device registration applications; 1,588 changes were registered, accounting for 50.9% of the total number of imported Class III medical device registration applications. The distribution of registration forms is shown in Figure 4.
Figure 4. Distribution of registration forms of imported Category III medical device registration acceptance items
II. Medical device registration and approval
In 2023, the NMPA approved 12,213 initial registration, extended registration and change registration of medical devices, an increase of 2.3% compared with the total number of registration approvals in 2022. Of these, 2,728 were registered for the first time, an increase of 9.1 percent compared to 2022. The number of extended registrations was 4,788, a decrease of 8.2% compared with 2022 and a decrease for two consecutive years. There were 4,697 changes in registration, an increase of 11.2% compared to 2022. In 2023, enterprises will withdraw their initial registration applications and cancel registration certificates on their own 287 items. The registration of medical devices approved by the State Food and Drug Administration in the past 10 years is shown in Figure 5.
Figure 5.Number of NMPA device registrations from 2014 to 2023
i. Overrall situation
2023 NMA approved 6,151 Category III medical device registrations in China, an increase of 8.1% compared with 2022, and 6,062 imported medical devices, a decrease of 3% compared with 2022.
Figure 6.NMPA2023 medical device registration form and quantity ratio chart
According to the registered varieties, 9130 medical devices, accounting for 74.8% of the total number of medical devices registered; There were 3,083 in vitro diagnostic reagents, accounting for 25.2% of the total number of registered medical devices. According to the registration form, 2,728 items were registered for the first time, accounting for 22.3% of the total number of medical device registrations; 4788 continued registrations, accounting for 39.2% of the total number of medical device registrations; 4697 changes were registered, accounting for 38.5% of the total number of medical device registrations. The proportion of registration forms is shown in Figure 6.
ii. Itemized situation
(i) Registration and approval of domestic Class III medical devices
There were 6,151 domestic registrations of Class III medical device. Among them, 4667 were medical devices and 1484 were in vitro diagnostic reagents. From the registration form, the first registration of 2079, accounting for 33.8% of the total number of domestic registration of Class III medical device, the continuation of registration of 1897, accounting for 30.8% of the total number of domestic registration of Class III medical device; licensing matters to change the registration of 2175, accounting for 35.4% of the total number of domestic registration of Class III medical devices. The distribution of registration forms is shown in Figure 7.
（ii）Registration and approval of imported Category II medical devices
2,947 types of imported medical devices were registered. Among them, 1,654 medical devices were registered and 1,293 in vitro diagnostic reagents were registered.
Figure 8. Distribution of registration forms of imported Type II medical devices
In terms of registration forms, 300 items were registered for the first time, accounting for 10.2% of the total number of imported Class II medical devices. Continued registration of 1707 items, accounting for 57.9% of the total number of imported Class II medical devices; There were 940 registered changes in licensing matters, accounting for 31.8% of the total number of imported Class II medical devices. The distribution of registration forms is shown in Figure 8.
(iii) Registration and approval of imported Class III medical devices (iv) Registration and approval of imported Class III medical devices
3115 types of imported medical devices were registered. Among them, 2,809 medical devices and 306 in vitro diagnostic reagents were registered. In terms of registration forms, 349 items were registered for the first time, accounting for 11.2% of the total number of imported Class III medical devices. Continued registration of 1,184 items, accounting for 38% of the total number of imported Class III medical devices; There were 1,582 registered changes, accounting for 50.8% of the total number of imported Class III medical devices. The distribution of registration forms is shown in Figure 9.
Figure 9. Distribution of registration forms of imported Class III medical devices
（iv）Monthly approval of the first registered project
In 2023, the NMPA approved a total of 2728 medical devices for the first time registration, and the monthly approval number is shown in Figure 10.
Figure 10. NMPA monthly approved number of first registrations
（v）Analysis of specific approved varieties
The Class three Domestic medical devices registered, in addition to in vitro diagnostic reagents, involved a total of 18 sub-directories in the Medical Device Classification Catalogue. Class three of the top five Domestic medical devices registered by volume were: passive implant devices; neurological and cardiovascular surgical instruments; infusion, nursing and protective instruments; active surgical instruments; and medical imaging instruments.
Figure 11. Category III medical device quantity layout map.
The registered imported medical devices, in addition to in vitro diagnostic reagents, involve a total of 22 sub-directories in the Medical Device Classification Catalogue. The top five imported medical devices registered were mainly: Passive implant devices, dental instruments, ophthalmic instruments, medical imaging instruments, active surgical instruments, compared with 2022, great changes, ophthalmic instruments to replace infusion, nursing and protective instruments, active surgical instruments to replace neurological and cardiovascular surgical instruments, the number of passive implant devices increased by 43.3%, the number of oral instruments increased by 57.8%, The number of medical imaging device registrations decreased by 44.2%.
Figure 12. Ranking of Registered Varieties of Imported Medical Devices
（v）Country situation of imported medical devices
In 2023, a total of 31 countries (regions) products have been approved for listing in China. Among them, the United States, Germany, Japan, South Korea, and France ranked among the top 5 in the number of medical device imports registered for the first time in China, and the number of registered products accounted for about 77% of the total number of imported products registered for the first time in 2023, a slight increase compared with 2022.
From the distribution of imported medical device agents, a total of 16 provinces involved enterprises in the province as imported medical device agents, of which Shanghai’s imported medical device agents agent imported medical devices for the first time the largest number, accounting for 64% of all imported medical devices for the first time registration
（vi）Analysis of the domestic first registration provinces for Class III medical device
From the first registration of the third class of domestic medical devices in 2023, the relevant registrants were mainly concentrated in the coastal provinces with more developed economies. Among them, Jiangsu, Guangdong, Beijing, Zhejiang and Shanghai were the top five provinces in terms of the number of first registrations of third class medical devices in China, accounting for 68% of the number of first registrations of third class domestic medical devices in 2023, but slightly reduced compared with 2022.
(vii）Registration approval of innovative medical devices and other products
In 2023, NMPA continued to do a good job of reviewing related products in accordance with the Special Review Procedure for Innovative Medical Devices, Priority Approval Procedure for Medical Devices, and received a total of 466 applications for special approval of innovative medical devices, an increase of 35.9% from 2022, of which 69 were approved to enter the special review procedure for innovative medical devices.
From 2014 to 2023, a total of 250 innovative medical devices have been approved by the NMPA. Among them, the domestic innovative medical devices involved 167 enterprises in 16 provinces, and the imported innovative medical devices involved 18 enterprises in 5 countries. Beijing, Shanghai, Guangdong, Jiangsu, and Zhejiang had the highest number of approved products and corresponding enterprises for innovative medical devices, accounting for about 78.4 per cent of all approved 250 innovative medical devices, but declining compared to 2022.
Translated & edited by Bradyknows
