NMPA Released Five Guidelines in One Day

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

Technical Review Guidelines for Genetic Deafness Related Mutation Detection Reagent

Technical Review Guidelines for Cryptococcus Capsular Polysaccharide Antigen Detection Reagent

Technical Review Guidelines for IgM/IgG Antibody Detection Reagent for Mycoplasma Pneumoniae

For Medical Devices

Technical Review Guidelines for Predicate Clinical Evaluation of X-ray Computed Tomography Devices

Technical Review Guidelines for Predicate Clinical Evaluation of Imaging Ultrasonic Diagnostic Devices

For the completed guidelines, please contact us (info@inspirativemed.com).

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 China guidelines or standards and those of your products.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210118173649147.html

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210119165337134.html