NMPA Acceptance Summary Of Medical Device Registration Application In 2021

NMPA Acceptance Summary of Medical Device Registration Application in 2021

In 2021, NMPA accepted 12,255 applications for initial registration, renewal registration and change registration of medical devices, an increase of 15.8% compared with 2020.

Overall situation

NMPA accepted 5,338 domestic class III medical device registration applications and 6,917 imported medical device registration applications.

According to the registration category, there are 8,540 applications for medical devices and 3,715 applications for in vitro diagnostic reagents.

According to the registration form, there are 2,750 initial registration applications, accounting for 22.4% of all medical device registration applications; 5,875 applications for renewal registration, accounting for 48% of all medical device registration applications; 3,630 applications for change registration, accounting for 29.6% of all medical device registration applications.

Registration acceptance summary of imported class II medical devices

NMPA accepted 3,689 imported class II medical devices, an increase of 11.4% compared with 2020. Among them, 2,048 applications for medical devices and 1,641 applications for in vitro diagnostic reagents.

In terms of registration form, there are 435 applications for initial registration, accounting for 11.8% of the total number of applications for imported class II medical devices; 2,122 renewal registrations, accounting for 57.5% of the total number of applications for imported class II medical devices; 1,132 change registrations, accounting for 30.7% of the total number of applications for imported class II medical devices.

Registration acceptance summary of imported class III medical devices

NMPA accepted 3,228 registrations of imported class III medical devices, an increase of 5.9% compared with 2020. Among them, 2,759 applications for medical devices and 469 applications for in vitro diagnostic reagents.

In terms of registration form, there are 435 applications for initial registration, accounting for 13.5% of the total number of applications for imported class III medical devices; 1,597 renewal registrations, accounting for 49.5% of the total number of applications for imported class III medical devices; 1,196 change registration, accounting for 37% of the total number of applications for imported class III medical devices.