DMF

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

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

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

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

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

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

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.