China Establishes Voluntary Medical Device Master File Registration System

To streamline the collection of data on raw materials used in the manufacture of medical devices, Chinese regulators in March established a voluntary registration system for suppliers. Under the system, applicants for sales permits for many medical device products may register a Device Master File (DMF) with the Center for Medical Device Evaluation, part of the Chinese National Medical Products Administration (NMPA).

The DMF will list the raw materials used in the products, their characteristics, stability, and use. Having the information on file will make it possible for manufacturers to share technical information with regulators during device registrations without the need to submit the same data for multiple products. At the same time, the move is designed to facilitate the confidentiality of raw materials used in medical devices.  The move has been in the works since early 2019.