2025 medical device registration approval list
Medical Device Registration Approval
2025, the State Food and Drug Administration approved a total of 14187 first registration, renewal registration and change registration of medical devices,compared to 2024.
Among them, 3402 items are registered for the first time, 5056 items are registered for continuation, and 5729 items are registered for change.
2025, enterprises will withdraw their first registration applications and cancel 331 registration certificates.
The registration of medical devices approved by the State Food and Drug Administration in the past 12 years is shown in Figure 5.
1. Overall situation
2025, the State Food and Drug Administration approved 8147 registered Class III medical devices and 6040 imported medical devices.
According to the registered varieties, there are 10621 medical devices, accounting for 74.9 of the total number of registered medical devices, and 3566 in vitro diagnostic reagents, accounting for 25.1 of the total number of registered medical devices.
According to the registration form, 3402 items were registered for the first time, accounting for 24% of the total number of medical device registrations. Continue to register 5056 items, accounting for 35.6 of the total number of medical device registrations; Change registration 5729 items, accounting for 40.4 of the total number of medical device registrations. The proportion of registered forms is shown in Figure 6.
2. Sub-item situation
1. Registration and Approval of Class III Medical Devices in China
. Among them, medical devices 6204 items, in vitro diagnostic reagents 1943 items.
, from the registration form, 2760 items were registered for the first time, accounting for 33.9 of the total number of Class III medical devices registered in China, 2456 items were continued, accounting for 30.1 of the total number of Class III medical devices registered in China, and 2931 items were changed, accounting for 36.0 of the total number of Class III medical devices registered in China. The distribution of registration forms is shown in Figure 7.
2. Registration and approval of imported Class II medical devices
imports of Class II medical devices 3102 items. Among them, 1907 medical devices were registered and 1195 in vitro diagnostic reagents were registered.
from the registration form, 270 items were registered for the first time, accounting for 8.7 of the total number of imported Class II medical devices; 1450 items were continued to be registered, accounting for 46.7 of the total number of imported Class II medical devices; 1382 items were changed, accounting for 44.6 of the total number of imported Class II medical devices. The distribution of registration forms is shown in Figure 8.
3. Registration and Approval of Imported Class III Medical Devices
2938 items of registration for imported Class III medical devices. Among them, 2510 medical devices were registered and 428 in vitro diagnostic reagents were registered.
from the registration form, 372 items were registered for the first time, accounting for 12.7 of the total number of imported Class III medical devices; 1150 items were continued, accounting for 39.1 of the total number of imported Class III medical devices; 1416 items were changed, accounting for 48.2 of the total number of imported Class III medical devices. The distribution of registration forms is shown in Figure 9.
3. Monthly Approval of First Registration Projects
2025, the monthly approval of the first registration of the State Food and Drug Administration is shown in Figure 10.
4. Analysis of specific approved varieties
, except for in vitro diagnostic reagents, involves products from 18 subdirectories in the "Medical Device Classification Catalog.
The top five registered domestic Class III medical devices are:Passive Implantable Devices,active surgical instruments,Neurological and cardiovascular surgical instruments,Stomatology Equipment,Medical Imaging Devices. Compared with 2024, the registered number of passive implanted devices increased by 5.1 year on year, active surgical devices exceeded nerve and cardiovascular surgical devices, and the registered number increased by 34.5 year on year. Medical imaging devices exceeded infusion, nursing and protective devices and entered the top five. The registered number of other categories decreased, such as infusion, nursing and protective devices decreased by 31.9 year on year, neurological and cardiovascular surgical instruments decreased by 19.9 YoY, and dental instruments decreased by 1% YoY.
registered imported medical devices, in addition to in vitro diagnostic reagents, a total of "medical device classification directory" in the 21 sub-directory products
are:Stomatology Equipment,Passive Implantable Devices,Ophthalmic Devices,Medical Imaging Devices,active surgical instruments. Compared with 2024, the change is large. Stomatological devices exceed passive implanted devices, ranking first, with the number of registrations increasing by 24% year-on-year. Ophthalmic devices exceed active surgical devices, with the number of registrations increasing by 35.2 year-on-year. Medical imaging devices exceed active implanted devices and enter the top five, while the number of registrations in other categories decreases slightly.
5. Imported medical devices by country
2025, a total of 30 countries (regions) products were approved for listing in China.
Among them, the United States, Germany, South Korea, Japan, 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 75.4 of the total number of imported products registered for the first time in 2025.
from the distribution of imported medical device agents, a total of 19 provinces involved in the province's enterprises as imported medical device agents, of which Shanghai agents imported the largest number of medical devices for the first time, accounting for 62.1 of the total number of imported medical devices.
6. Analysis of the third category of medical devices in the territory of provinces
From the registration of Class III medical devices in 2025, the relevant registrants are mainly concentrated in the more developed coastal provinces.
Among them, Jiangsu, Guangdong, Beijing, Shanghai and Zhejiang are the top five provinces in the first registration of category III medical devices, accounting for 65.1 of the first registration of category III medical devices in 2025.
Sources | Chinese Medicine Smell
