The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification.
Classification Catalog 2020 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, the NMPA will accept applications for registration and filing of medical devices according to the updated Classification Catalog 2020 list.
For medical devices that have been accepted and have not approved (including the initial and renewal registration), the 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 Catalog.
CMD can evaluate the gap between the “Classification Catalog” amendment and your product and help you with your registration.