Category: Guideline

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 MRI systems adopting AI technology,

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 and filing, encompassing both domestic

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