As of the beginning of this year, 1st January 2024, Hong Kong’s Medical Device Division (MDD) has started accepting marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and the National Medical Products Administration (NMPA) of China for the listing application of general medical devices and in vitro diagnostic medical devices.
This is done to support the compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under Hong Kong’s Medical Device Administrative Control System (MDACS).
Along with the changes stated above, the following Guidance Notes and application forms has been updated in response to the new addition of accepted marketing approvals:
Guidance Notes: GN-01, GN-02, GN-06
Application form: MD101, MD102
If there are approvals for the device to be marketed in any of the GHTF founding members, namely Australia, Canada, the European Union (EU), Japan and the USA; China and/or Korea, the Local Responsible Persons (LRPs) shall tick the appropriate boxes under index D1 of the submission folder and a copy of the approval documents shall be provided.
The list of all updated guidance (Department of Health | Issued Documents under MDACS (mdd.gov.hk)) and forms (Department of Health | Medical Device Division - Forms (mdd.gov.hk)) can be obtained from MDD’s website as linked.