The Medical Device Division (MDD) now accepts on a regular basis the marketing approvals obtained from the National Medical Products Administration (NMPA) as a proof of compliance of Class II/III/IV General Medical Device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under the MDACS. Also, the acceptance of the marketing approval is extended to cover In Vitro Diagnostic Medical Devices (IVDMD) on trial basis until 31 December 2022.
Furthermore, the current Trial Scheme accepting marketing approvals obtained from the Ministry of Food and Drug Safety (MFDS) of Korea as a proof of compliance of Class II/III/IV General Medical Device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under the MDACS is extended until 31 December 2022.
Updated application forms and Guidance Notes in response to the above changes will be uploaded to our website (www.mdd.gov.hk) shortly.