JNM Global

Global Approval Partner

JNM Global 313

Hong Kong MDACS, Guidance Notes on Changes for Listed Medical Devices

Hong Kong Medical Device Division (MDD) issued formal guidance (GN-10 Guidance Notes on Changes for Listed Medical Devices) on the requirements to maintain compliance when making changes to a medical device registered with the Medical Device Administrative Control System (MDACS). The GN-10 guidelines include classification of whether changes to registered medical devices are major or minor and m..