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2026 China NMPA Bluebook is here:
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines The guidelines are prepared by NMPA
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 round released in May 2020.
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
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