Announcement of the acceptance of marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)
2024-01-19
Starting from 1 January 2024, the Medical Device Division (MDD) accepts on a regular basis the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
Furthermore, starting from 1 January 2024, MDD also accepts on a regular basis the marketing approvals obtained from the Ministry of Food and Drug Safety (MFDS) of Korea as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
The following updated Guidance Notes and application forms in response to the above changes are uploaded to Medical Device Division website (www.mdd.gov.hk):
- Guidance Notes: GN-01, GN-02, GN-06
- Application form: MD101, MD102
