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2026 China NMPA Bluebook is here:
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 summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601. The standards have been effective since May 1, 2023. 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 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 “Guideline on Recombinant Humanized Collagen Raw Materials” and “Guideline on Recombinant Collagen Wound Dressings” on May 23, 2023. The two guidelines are
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.
On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported
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 granted innovation approvals to seven devices in April 2023, for indications ranging from cardiovascular, orthopedic, neurology and ophthalmic. Among them are two imported
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.