The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023. Read the list of NMPS down-classified devices.
Full list of NMPA Down-classified Devices
The following devices are down classified from Class III to Class II:
- Ultrasonic surgical equipment accessories: used for cutting and crushing bone tissue (including teeth) during surgery. Cooperate with the host of ultrasonic bone tissue surgery equipment
- Separation control box: used to provide power during interventional surgery and release the coil
- Introducer cannula: used with a needle to insert a catheter or guidewire
- Guidewire: used to guide the insertion and positioning of a catheter or dilator into a blood vessel
- Vertebroplasty instrument: used for fracture reduction and/or forming a cavity in the cancellous bone of the vertebral body that can be filled with fillers to restore the height of the vertebral body
There are also some devices revlassified from Class II to Class I.
For the complete list of ten 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 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.