The 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:
NMPA Classification March 2022
- Biochemical analysis instrument
- Western blotting instrument
- Biochemical immunoassay instrument
- Nucleic acid amplification analysis instrument
- Image scanning equipment
- Mass detection system
- Liquid Chromatography Instruments
- Orthopedic powered surgery equipment
- Calcium Salt Bone Filling Implants
- Tooth Bleaching Equipment
- planting aids
- tooth bleaching material
- Mobile C-arm X-ray machine
- Injectable fillers for plastic surgery
- Ophthalmic Laser Diagnostic Equipment
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 the NMPA’s 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.
About China Med Device, LLC
China Med Device, LLC provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.