Hong Kong market access
Medical Device Administrative Control System (MDACS) registration
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).
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), such as BSI who are recognized by the Medical Device Control Office (MDCO).