Register for Upcoming Webinar on DEC. 8 @ 11AM

New white paper available now!

NMPA Down-Classified Certain Neuro, Cardiac Surgery Devices

Share:

The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and aesthetic devices and modified intended use for some with an announcement on March 24, 2022.

NMPA Neurosurgical Devices

The following neurosurgical and cardiac surgery devices are down classified from Class III to Class II:

  1. catheter sterilization connector
  2. puncture needle
  3. catheter sheath
  4. dilator
  5. connection valve
  6. extension tube

For the complete list of ten reclassifications or if you have similar device entering China, please contact us via 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 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.

Please visit our service page for more in-depth medical device classification information.

Related Posts