Friday, 2, May, 2025 / Published in China, DMF, Medical Devices, News

China’s Medical Device Master File System: Facilitating Market Entry for Global Manufacturers

Effective from the implementation of China’s medical device master file registration system, international manufacturers are now able to submit detailed…

Tuesday, 31, October, 2023 / Published in China, DMF, Medical Devices, News

China medical device master filing – Overview of application insights

China medical device master filing (MDMF) was introduced for implementation (No.36-2021) by the National Medical Products Administration (NMPA) to protect…

Thursday, 11, May, 2023 / Published in China, DMF, News, Webinars

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 discussing the intricacies…

Friday, 24, February, 2023 / Published in China, DMF, Medical Devices, News

Medical Device Master Files in China – clarification on use

Medical Device Master Files in China were introduced in 2021 but the NMPA has recently clarified their use for the…

Monday, 26, July, 2021 / Published in China, DMF, News

Regulatory Insights for Drug Master Filing (DMF) in China

Drug master filing (DMF) is a relatively recent regulatory change by China’s NMPA (National Medical Products Administration) permitting active pharmaceutical…

Wednesday, 24, March, 2021 / Published in China, DMF, Medical Devices, News

NMPA Introduces the Medical Device Master Filing System

On March 12, 2021, the NMPA (National Medical Products Administration) announced (No.36-2021) the implementation of a medical device master filing…

Wednesday, 1, April, 2020 / Published in China, DMF, News

New fees, tests and document requirements for DMF registration of APIs

There has been a recent and important change regarding the DMF (Drug Master File) registration of APIs (Active Pharmaceutical Ingredients)…