The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example names for 31 medical devices.
The impacted devices include but not limited to the following:
- Spinal Probe
- Bone marrow aspiration and biopsy system electric drill
- Mobile C-arm X-ray machine
- Patient monitor
- Oxygen inhaler
- RF hyperthermia system
- Dental hydroxyapatite biomaterial
- Calcium sulfate artificial bone
- Silicone rubber surgical implants
- Sodium hyaluronate acid for injection
- Laser scanning ophthalmoscope
- Tooth bleach
- Natural rubber latex condom
- fully automatic bio analysis machine
- Microbial mass spectrometer
- Blood count plate
Along with the massive reclassifications of medical devices in August 2017, this proposal is part of the NMPA’s goal to be more dynamically adapting to the market needs to introduce needed device to the market faster. NMPA tends to consolidate requests of the reclassifications for feedback and then issue a more comprehensive classification catalogue update over a year or more time period.
This med device classification notice for feedback is described as a dynamic process. It is trying to balance the risk and benefit more efficiently and faster access to patient needs. With NMPA recent announcements in real-world data and post-market data evaluation, different market entry strategies could be deployed. If finalized, it will reduce costs and time for the medical device manufacturers. Class III and class II submission requirements in documentation, testing and clinical evaluation are different, almost like PMA and 510K in the US.
The NMPA welcomes comments regarding this notice. If you have any questions about the proposed reclassifications, please contact us at info@ChinaMedDevice.com. We will consolidate the opinions and submit to NMPA.
For IVD down-classifications catalog issued in November 2020, please click HERE
For AI software classification issued in July 2021, please click HERE