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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)

The Medical Device Division (MDD) extends the trial scheme on accepting the marketing approval from either the National Medical Products Administration (formerly known as China Food and Drug Administration) or the Ministry of Food and Drug Safety of Korea as 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. The trial scheme will expire on 30 June 2021.

If you are interested in joining this trial, please click here to download the application form for this trial to download the application form for this trial and refer to the “Guidance Notes for Listing Class II/III /IV General Medical Devices”(Guidance Notes: GN-02) to fill in the form (except items A003 and D001). The original copy of the completed application form together with the supporting documents must be submitted, by hand or by mail, to the MDD. Applicants are encouraged to provide softcopies of supporting documents in portable storage devices (PSDs) as far as possible.

Medical Device Division, Department of Health

24 December 2020

 
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Last Revision Date : 24 December 2020