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2026 China NMPA Bluebook is here:
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” scenario. CMDE released the review
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 and industry leaders discussed artificial
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 Med Device, LLC, your partner
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 of 5 IVD Draft Guidelines
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 YY 0719.2-2022 Ophthalmic optics –
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 Class III, imported Class II
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, 2022. View our service page
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 therapy equipment. For an English
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. Product Life-cycle Process The guideline
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for September 2022. These updates are presented by China Med Device, LLC, your partner
The NMPA released the “Draft Guideline on Continuous Glucose Monitoring System” on September 28, 2022, for feedback. Feedback needs to be submitted by October 14, 2022. Highlights of the NMPA
NMPA In Vitro Diagnostic Reagents The NMPA In vitro diagnostic reagents issued 6 guidelines on September 28, 2022: Guideline on Qualitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation Guideline