Category: Guideline

NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first

The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to

The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology infrastructure for medical device registration

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

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

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

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

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

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

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.

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