IVD 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. Medical device and IVD product registration is voluntary in Hong Hong for Class II and above medical devices and Class D IVD devices. However the Hospital Authority requires or gives preference to registered medical devices in public hospital purchasing.
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.
If you are interested in voluntarily registering your medical device in Hong Kong, please contact Asia Actual for a free consultation.