Hong Kong's Medical Device Division (MDD) announced that they will continue the trial to accept marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS) as proof that it has complied with “Essential Principles of Safety and Performance of Medical Devices” for listing application general medical device class II/III/IV. This stipulation will continue until December 31, 2021
This trial study itself has been conducted starting from the acceptance of Marketing approval of China's NMPA since 2018 and MFDS Korea since 2019.
Thereon, to join the trial, applicants are directed to download the application form first here (link). And directed to fill in accordance with Guidance Notes: GN-02 (link) (except for items A003 and D001).
Continuance of trial to accept marketing approval obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)