NMPA Released Seven IVD Guidelines in a Week

On December 9, 2020, NMPA released seven guidelines on IVD products. These were put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. All the new guidelines are:

 Technical Review Guidelines for the Registration of Household In Vitro Diagnostic Medical Devices
 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

Bradynuoen suggest manufactures to follow the new requirements to do relevant registration. Surveillance for IVD products is becoming more and more stringent in China so Brady can help you evaluate the gap between your products and China guidelines or standards.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201209161426192.html