New Regulation for "Customised medical devices" in China

The Chinese State Drug Administration in conjunction with the National Health and Health Commission issued the "Regulations for the Supervision and Management of Customized Medical Devices " (Order 53 of 2019) that will be effective from January 1, 2020.


The Regulation includes a definition of "Personalised medical devices" and separates them into "customised medical devices" and "patient-matched medical device".