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2026 China NMPA Bluebook is here:
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.
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 the “2023 Medical Device Guidelines Revisions Plan” on April 4, 2023, in which 247 guidelines are affected. The revisions are aimed to
The National Health Insurance Administration issued the “Reply to Recommendation No. 3298 of National People’s Congress” on March 4, in which the Administration agrees to
The following 32 innovative devices NMPA have been mentioned in 2022 Innovation Approval Notices published by the NMPA. China Med Device, LLC categorized them by
The NMPA published a notice “Further Clarify the Registration and Use of Medical Device Master Files” on January 18, 2023. To protect medical device raw
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
There have been 181 guidelines issued by the NMPA in 2022. The revised or newly established guidelines are aimed to facilitate manufacturers with local type
The NMPA released the “Review Key Points of Recombinant Human Collagen Injection Materials for Plastic Surgery (Draft)” on December 29, 2022, directing manufacturers on type
The NMPA granted innovation approvals to two radiology devices, used in combination for ultrasound imaging of intravascular lesions in coronary arteries. There have been 185