Category: Guideline

The NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the

The NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Full List For an English copy of any

The NMPA published 30 guidelines in July 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. For English copies of any guidelines below, please email

The NMPA released the “Guideline on Continuous Glucose Monitoring System” on July 18, 2023. It is the finalized version from the draft issued in September 2022. Highlights of the Guideline

The NMPA published 14 guidelines on July 6, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. For English version of any guidelines below, please

The NMPA issued “Guideline on Recombinant Humanized Collagen Raw Materials” and “Guideline on Recombinant Collagen Wound Dressings” on May 23, 2023. The two guidelines are final versions after the drafts

The NMPA published the 29 guidelines in April 2023, which involve a wide range of indications, from ophthalmic, vascular to urology and cosmetic device, etc. It is to facilitate manufacturers

The NMPA published the “2023 Medical Device Guidelines Revisions Plan” on April 4, 2023, in which 247 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type

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.