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.
For IVD Products
- Technical Review Guidelines for the Registration of Home-Use In Vitro Diagnostics
- Technical Review Guidelines for the Registration of Specific Protein Immunochemistry Analyzer
- Technical Review Guidelines for the Registration of Prolactin Detection Reagent
- Technical Review Guidelines for the Registration of Total Triiodothyronine Detection Reagent
- Technical Review Guidelines for the Registration of 25- hydroxyvitamin D Detection Reagent
- Technical Review Guidelines for the Registration of Serum amyloid A Detection Reagent
- Technical Review Guidelines for the Registration of RF (rheumatoid factors) Detection Reagent
Nomenclature Guidelines
Different kinds of medical devices are affected:
- Orthopedic surgery devices
- Blood transfusion, dialysis and extra-corporeal circulation devices
- Passive surgery devices
- Passive implant devices
- Disinfection & sterilization devices
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 info@chinameddevice.cn.
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.