NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022.

The classification and definition of the following devices are affected:

Analytical

• Biochemical analysis instrument
• Western blotting instrument
• Biochemical immunoassay instrument
• Nucleic acid amplification analysis instrument
• Image scanning equipment
• Mass detection system
• Liquid Chromatography Instruments

Orthopedic

• probe
• Orthopedic powered surgery equipment
• Calcium Salt Bone Filling Implants

Dental

• Tooth Bleaching Equipment
• planting aids
• tooth bleaching material

Radiology

• Mobile C-arm X-ray machine

Aesthetic

• Injectable fillers for plastic surgery

Ophthalmic

• Ophthalmic Laser Diagnostic Equipment

For the complete list of 27 reclassifications or if you have similar device entering China, please email info@ChinaMedDevice.com.

Implication of the Down-Classification

Along with the massive reclassifications of medical devices in August 2017, this announcement is part of the NMPA’s goal to be more dynamically adapting to the market needs to introduce needed device to the market faster. It is trying to balance the risk and benefit more efficiently and getting patient faster access to life saving or much needed devices. With NMPA recent announcements in real-world data and post-market data evaluation, different market entry strategies could be deployed. The re-classification will reduce costs and time for the device manufacturers, as Class III and class II submission requirements in documentation, testing and clinical evaluation are different, almost like PMA and 510K in the US.

For our service page of medical device classification, please visit HERE