Category: Guideline

The National Institutes for Food and Drug Control of NMPA released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and

NMPA published the “Guideline for Registration of Mobile Medical Devices” on May 7, 2025, replacing the 2017 version. This updated guideline is to facilitate manufacturers

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