Updates on the Medical Device Classification Catalogue in China

On December 31, 2020, the NMPA announced (No.147-2020) a total of 28 updates on the classification catalogue for medical devices including 15 classification changes and 13 content updates.

Amongst the 15 classification changes, the following 9 class II products were down-classified to class I:

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

The following 6 class III products were down-classified to class II:

• Endoscopic surgery equipment
• Urinary X-ray machine
• Oral X-ray machine
• Optical Endoscope
• Electronic Endoscope
• Endoscope insertion shape observation system

The contents of the following 13 products were updated in the classification catalogue:

• Argon protective gas condensation equipment
• Electric stapler
• Fluoroscopy X-ray machine
• Atomizing mask
• Oxygen mask
• Ophthalmic ultrasound diagnostic equipment
• Prosthetic eye piece
• Bone meal preparation equipment for oral cavity
• Materials and products for maxillofacial prosthesis and restoration
• Gingival retraction material
• Triangular needle
• Skin needle
• Roller pin

The latest medical device classification catalogue is already in effect since the date of the announcement on December 31, 2020.

By Jacky Li. Contact Cisema if you would like to learn more.