Medical Device Registration in Hong Kong

The market for medical devices in Hong Kong is about $600 million. Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. The Department of Health (DOH) is the main health authority in Hong Kong. Under the DOH, the Medical Device Control Office (MDCO) regulates medical devices.

Hong Kong currently has no mandatory registration for medical devices, but manufacturers and importers can opt for voluntary registration under the Medical Device Administrative Control System (MDACS). The government intends to make the MDACS a mandatory system in the near future.

For products voluntarily listed in the MDACS, conformity assessment during both design and manufacturing is now a requirement. Manufacturers can demonstrate their compliance with an audit conducted by a Conformity Assessment Body (CAB), a third-party assessor recognized by the Medical Device Control Office (MDCO).

For more information on medical device registration in Hong Kong, please see the following PBM publications and/or contact us to discuss your specific needs.