Hong Kong Legislature Considers Mandatory Medical Device Registration Requirements

Legislation for the creation of mandatory medical device regulations was introduced into the current legislative session in Hong Kong. Regulations and requirements are expected to be very similar to those under the current voluntary system. If passed into law before the close of session in July, implementation is expected in the beginning of 2018.

Because the voluntary Medical Device Administrative Control System (MDACS) has been in place since 2004, the Department of Health is not expected to provide for a transition period. Devices that are not registered by the implementation date will loose access to the Hong Kong market. Manufacturers are encouraged to participate in the voluntary system to avoid any potential loss of market access.

Overview of the Current Hong Kong Registration Process

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).

While manufacturers can use a Conformity Assessment Body (CAB) to review their technical documents, most manufacturers will leverage a Reference Country approval to expedite market access. ISO 13485 or equivalent is also required and listings are valid for 5 years with an administrative review.

For the latest registration information, including timelines and fees, see our Medical Device Registration page.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions related to medical device registration in Hong Kong or throughout the region.