NMPA Released Five Guidelines in One Day

NMPA Released 12 Guidelines in One Day
January 18, 2021

NMPA Released Five Guidelines in One Day

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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 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.