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2026 China NMPA Bluebook is here:
The NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of
The NMPA issued the final document of “2023 Medical Device Industry Standards Revisions Plan” on May 24, two weeks after the release of draft version.
The NMPA issued the draft version of “2023 Medical Device Industry Standards Revisions Plan” on May 12, 2023, with the deadline for feedbacks on May
The NMPA published 20 industry standards on March 17, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. NMPA Industry
The NMPA issued “2024 National Medical Device Clinical Evaluation Standards Project Proposals” on March 8, 2023, asking proposals by June 30, 2023. Those received thereafter
The NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. NMPA Industry
There have been 108 standards issued by the NMPA in 2022. The revised or newly established standards are aimed to facilitate manufacturers with local type
The NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400
The NMPA published twenty industry standards on October 17, 2022, to guide manufacturers for local type testing and regulatory approval. Mandatory NMPA Standards October 2022
The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research
The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary
The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval: YY/T 0273-2022 Dentistry-Dental amalgam