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 our website (www.mdd.gov.hk):