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.

Contact Asia Actual with any questions or support needs as the Hong Kong Legislature considers new regulations.