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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 released the final version of “Registration Guideline for Radiofrequency Aesthetic Devices” on April 12, 2023. The draft document was released on August 26,
The NMPA conducted a “fly inspection”, also known as an unannounced inspection, on Chenfang Sichuang Technology Co., Ltd. According to the notice published on April
The NMPA issued a notice on April 19, adding error correction matters into their electronic Regulated Product Submission (eRPS) system, effective on April 20, 2023.
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
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2023. These updates are presented by China
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 NMPA announced the “2023 National Inspection Plan for Medical Devices” today (March 31, 2023). The Plan asks provincial NMPA offices and testing centers to
Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone
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
48 AI independent software have been approved so far, according to work summary of Artificial Intelligence Medical Device Innovation Cooperation Platform that NMPA CMDE established