DMF

China medical device master filing - Overview of application insights
China medical device master filing - Overview of application insights

China medical device master filing aims to protect confidential information from being disclosed during the NMPA registration process

March 13, 2026
China medical device master filing - Overview of application insights
Medical Device Master Files in China – clarification on use
Medical Device Master Files in China – clarification on use

Medical Device Master Files in China were introduced in 2021 but the NMPA has clarified their use for the registration of medical devices

March 13, 2026
Medical Device Master Files in China – clarification on use
New fees, tests and document requirements for DMF registration of APIs
New fees, tests and document requirements for DMF registration of APIs

A recent important change regarding the DMF registration of APIs in China with a new online application system was implemented and a new registration form.

March 13, 2026
New fees, tests and document requirements for DMF registration of APIs
China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar
China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

"China DMF of API, Excipient & Packaging Materials: Market & Regulatory" will be an hour webinar session covering the process and trends...

March 13, 2026
China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar
Regulatory Insights for Drug Master Filing (DMF) in China
Regulatory Insights for Drug Master Filing (DMF) in China

Drug Master Filing permits APIs, excipients and packaging materials manufacturers protect intellectual property and market approval.

March 13, 2026
Regulatory Insights for Drug Master Filing (DMF) in China
NMPA Introduces the Medical Device Master Filing System
NMPA Introduces the Medical Device Master Filing System

The NMPA announced the implementation of a mNMPA Introduces the Medical Device Master Filing System covering both medical devices and IVDs.

March 13, 2026
NMPA Introduces the Medical Device Master Filing System
China's Medical Device Master File System: Facilitating Market Entry for Global Manufacturers
China's Medical Device Master File System: Facilitating Market Entry for Global Manufacturers

Learn how China’s medical device master file system supports confidential documentation, protects IP, and streamlines regulatory reviews for international manufacturers.

March 13, 2026
China's Medical Device Master File System: Facilitating Market Entry for Global Manufacturers

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