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2026 China NMPA Bluebook is here:
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 issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific
The NMPA published an article on artificial intelligence software for process optimization, illustrating what the clinical applications of the software and how to do software
The NMPA granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China”
The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022. Focusing on bio-digital integration, experts
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2022. These updates are presented by China
The NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022. Full List
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 electronic registration certificate for medical devices will be fully implemented, starting on November 1, 2022. After October 2020, when the electronic certificates for domestic
The NMPA issued six draft clinical guidelines, for predicate-comparison, on October 25, 2022, soliciting public opinions. Your feedback needs to be submitted by November 21,
Proton Therapy Equipment, by APACTRON Particle Equipment Co., received the innovation approval on September 26, 2022. The NMPA released the review report for the proton
The NMPA issued the “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, implementing from the day of release.