Today (February 11, 2019) the Medical Device Control Office (MDCO) opened the voluntary device registration system to Class B and C IVD devices. Previously only Class D (high risk) IVD devices were include under the Medical Device Administrative Control System (MDACS).
A copy of the Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06E (2019) can be found here.
The regulatory systems for IVD and medical devices is currently voluntary in Hong Kong and now open all but and Class A IVD devices Class I medical devices.
Manufacturers typically participate in the voluntary system to (1) gain a sales advantage as the Hospital Authority requires or gives preference to registered devices in public hospital purchasing decisions and (2) avoid confusion and delays that will come when the system becomes mandatory. To date more than 5,000 devices have been registered by the MDCO under the voluntary system.
Asia Actual has a office in Hong Kong staffed by experienced regulatory professionals. Please contact us with questions or support