Currently, medical device registration is voluntary in Hong Hong for Class II and above medical devices and Class D IVD devices. However, devices with a drug component or that emit radiation or radio wave energy may be subject to non-medical ordinances. Also, the Hospital Authority requires or gives preference to registered medical devices in public hospital purchasing.
Medical device registration is managed by the Medical Device Control Office (MDCO) of the Department of Health. The regulatory system closely follows GHTF guidelines on medical device definition and classification.
Applicants may submit reference country approval in lieu of undergoing local conformity assessment by a Conformity Assessment Body (CAB), of which three companies are currently qualified: BSI, SGS, and TUV SUD. ISO 13485 or an FDA Establishment Inspection Report is required to demonstrate quality systems conformity.
The application processing time for the MDCO is scheduled to take 12 weeks, however delays are common. There is no processing fee. Successful device applications will receive a listing number and be listed in the MDCO on-line database. Listings are valid for 5 years.