Category: Market Authorization Holder

MAH Available in GBA, Green-Lighting Contract Manufacturing

June 29, 2022

The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities

Implantable Cardioverter Defibrillator, Intracranial Embolization Device Allowed for Contract Manufacturing

March 24, 2022

The NMPA published the “Catalog of Medical Devices Prohibited from Contract Manufacturing” on March 24, 2022. Compared with the draft version, issued in November 2021,

Category: Market Authorization Holder

MAH Available in GBA, Green-Lighting Contract Manufacturing

Implantable Cardioverter Defibrillator, Intracranial Embolization Device Allowed for Contract Manufacturing

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57 NMPA Guidelines Released in a One Day: Is Your China Registration Strategy Still Current?

NMPA Draft Clinical Guideline on Cardiac RF Ablation Devices – Implications for Boston Scientific, J&J, and Abbott

Clinical Evaluation of AI-Assisted Diagnostic Medical Devices — Draft Guideline Asks Feedback

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Key Takeaways and Best Practices of China Human Factor/Usability

Key Takeaways and Best Practices of China Human Factor/Usability

202505 NMPA News Roundup

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