NMPA published five guidelines on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval.
For IVD Products
For Medical Devices
For the completed version of above guidelines, please contact us at info@ChinaMedDevice.com.
China Med Device suggest manufactures to follow the new requirements to do relevant registration. Surveillance for IVD products is becoming more and more stringent in China so CMD can help you evaluate the gap between China guidelines or standards and those of your products.