Category: Guideline

There have been 181 guidelines issued by the NMPA in 2022. The revised or newly established guidelines are aimed to facilitate manufacturers with local type testing, pre-clinical, clinical trial, and

The NMPA released the “Review Key Points of Recombinant Human Collagen Injection Materials for Plastic Surgery (Draft)” on December 29, 2022, directing manufacturers on type test, preclinical testing, clinical evaluation,

NMPA issued the “Checkpoints of Common Violations of Regulations in the Production, Supply and Usage of Medical Cosmetic Devices” on November 25, 2022. It asks local NMPA offices to strengthen

The NMPA issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific research institutes, clinical institutions, etc.

The NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022. Full List of 5 IVD Draft Guidelines

NMPA In Vitro Diagnostic Reagents The NMPA In vitro diagnostic reagents issued 6 guidelines on September 28, 2022: Guideline on Qualitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation Guideline

The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and urology, etc. It is to

The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by NMPA reviewers and the device

The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval. IVD Guidelines NMPA

The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type