Medical Device product registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO).
Currently, medical device product registration is voluntary in Hong Kong for Class II and above medical devices and Class D IVD devices. While registration is voluntary, the Hospital Authority requires, or gives preference to, registered medical devices during public hospital tenders. Devices can be registered voluntarily through the Medical Device Administrative Control System (MDACS).
Medical Device Status
Products that make diagnostic, therapeutic, medical or rehabilitative claims are considered Medical Devices in Hong Kong. Devices with a drug component and devices that emit radiation or radio wave energy may be subject to additional non-medical ordinances.
Medical device classification closely follows the Global Harmonization Task Force (GHTF) classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.
Device Conformity Assessment
Medical Device registration in Hong Kong requires a local conformity assessment conducted by a Conformity Assessment Body (CAB), of which three companies are currently qualified: BSI, SGS, and TUV SUD. Local conformity assessments require a MDACS form, Instruction for Use (IFU), summaries on available clinical data and, in certain cases, test reports or other data in addition to fees paid to the CAB.
Application processing time is about 12 weeks, with no associated processing fees.