The Medical Device Division (MDD) extends the trial scheme on accepting the marketing approval obtained from the National Medical Products Administration (NMPA) as a support of compliance of Class B/C/D In Vitro Diagnostic Medical Device (IVDMD) to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under the Medical Device Administrative Control System (MDACS). The trial scheme will expire on 31 December 2023.
Furthermore, the current trial scheme accepting the marketing approval obtained from the Ministry of Food and Drug Safety (MFDS) of Korea as a support 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 30 June 2023.
Related application forms and Guidance Notes of the above trial schemes are uploaded on our website (www.mdd.gov.hk).