Medical Device Re-Registration in Hong Kong

A large number of medical device listings in Hong Kong are coming to the end of their 5-year validity period and must undergo a re-registration process in order to maintain an active Medical Device Listing.

The Hong Kong Medical Device Control Office (MDCO) is reminding industry that re-registration applications must be submitted at least three months prior to the expiry data to ensure continuous listing. Medical and IVD devices that are within 3 months of their listing validity date, or that have had a major change, must submit a new registration application. This could add significantly to the documentation requirements in support of the application. Individual reminders will not be issued by the MDCO, so manufacturers are advised to confirm with their Local Responsible Person about their specific deadlines and action plans.

While medical device registration is currently voluntary in Hong Kong, public hospital tenders will advantage or require listed medical devices. There are around 4,175 active medical devices listed in Hong Kong as of June 1, 2016.