The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature.
The guidelines were put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval.
Different kinds of medical devices are affected:
The normal nomenclature structure is “characteristic term 1 (if any) + characteristic term 2 (if any) + characteristic term 3 (if any) + essential term”. For example, reusable (characteristic term 1) flexible (characteristic term 2 ) vertebroplasty (characteristic term 3) hollow drill (essential term)
For the completed optional term lists of different medical devices, please contact us at email@example.com.
China Med Device suggests that manufactures 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.