NMPA Down-Classified Seven Class III Medical Devices

2021-01-21

NMPA released the updated Amendment of Medical Device Classification Catalogue on December 31, 2020, providing modification on management category and device classification.

Complete List

15 medical devices are down-classified, including seven class III and eight class II.

Previously Class III, Now Class II:

Active equipment for endoscopic surgery
Urinary X-ray machine
Oral X-ray machine
Optical endoscope
Electronic endoscope
Endoscope insertion shape observation system
Gynecological endoscope

Previously Class II, Now Class I:

Eyeball meter
Oral imaging aids
Planting equipment
Red blood cell sedimentation instrument
Microbial Turbidity Instrument
Medical microscope
Blood collection card
Counting board

Impact on Manufactures

From December 31, 2020, NMPA will accept applications for registration and filing of medical devices according to the updated Classification Catalogue.

For medical devices that have been accepted and have not approved (including the initial and renewal registration), NMPA will continue to review and approve the medical devices according to the original accepted category, and issue the medical device registration certificate but and indicate the updated management category will be indicated in the remark column of the registration certificate.

For the approved medical devices, the medical device registration certificate shall remain valid within the validity period. If renewal is required, application and renewal registration or filing shall be made according to the updated Classification Catalogue.

Brady can evaluate the gap between the “Classification Catalogue” amendment and your product and help you with your registration.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201231154216161.html