Updates on the Medical Device Classification Catalogue in China: 2020

On December 31, 2020, National Medical Products Administration (NMPA) issued “Announcement No. 147 of 2020,” introducing 28 updates to China’s medical device classification catalogue, including 15 classification changes and 13 content revisions. The updated catalogue took effect immediately upon publication and directly impacts China medical device registration pathways for domestic and international manufacturers.

For the 2026 update, read our article: China's NMPA Updates Medical Device Classification Catalogue, Affecting 31 Categories

Class II Devices Down-Classified To Class I

A significant portion of the update involves reduced regulatory burden for certain devices. Nine products previously categorized as Class II have been reclassified as Class I, indicating lower perceived risk and simplified filing requirements.

The affected devices include:

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

Class III Devices Down-Classified To Class II

The NMPA also reduced the classification of six higher-risk devices from Class III to Class II. This shift lowers the regulatory burden but still requires formal registration.

The reclassified devices include:

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

Catalogue Content Updates For 13 Medical Devices

In addition to classification changes, the NMPA updated the catalogue descriptions and technical scope for 13 devicesL

• 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

Further Information

Explore Cisema's services for medical device registration in China.

Read our blog articles on China medical device risk classification:

• China Medical Device Risk Classifications: How NMPA Device Class Determines Registration Pathways
• China IVD Risk Classification Explained: How NMPA Class Shapes Registration Pathways

Read our FAQ about China Medical Device and IVD Registration: China Medical Device and IVD Registration FAQs: What Foreign Manufacturers Need to Know About NMPA Requirements

About the Author: Jacky Li

Jacky Li is a Senior Manager at Cisema, based in Hong Kong and Taiwan. He has over a decade of experience in regulatory intelligence and market access, and serves as the lead supporting clients across Hong Kong, Mainland China (including the Greater Bay Area), and Taiwan, with a strong focus on pharmaceutical and medical device regulatory projects.