In 2021,NMPA approved 11,314 items of initial registration, renewal registration and change registration of medical devices, an increase of 14.9% compared with 2020.
Figure 1 Registration approval data from 2014 to 2021
Figure 1 Registration approval data from 2014 to 2021
NMPA approved 3,649 imported Class II medical devices and IVDs, including 2,132 medical devices and 1,517 in vitro diagnostic reagents, covering initial registration, renewal and modifications.
Imported Class III Medical Devices and IVDs
NMPA approved 3,069 imported Class III medical devices and IVDs, including 2,633 medical devices and 436 in vitro diagnostic reagents, covering initial registration, renewal and modifications.
NMPA Approval of Initial Registration
In 2021, NMPA approved the initial registrations of 1,710 medical devices. The below figure is the monthly approval status.
Analysis on Approved Categories for Imported Medical Devices
The top five imported medical devices are medical imaging devices, passive implant devices, dental devices, neurological and cardiovascular surgical devices and ophthalmic devices, the same as in 2020.
Analysis on the Home Countries of Imported Medical Devices
In 2021, the approved medical devices are from 27 countries (regions). Among them, medical devices from the United States, Germany, Japan, South Korea and Switzerland ranked among the top five for the initial registration of imported medical devices in China, accounting for about 72.5%, basically the same as that in 2020.
