A trial to accept marketing approval obtained from 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 Control Office (MDCO) will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conform to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) by presenting valid marketing approvals obtained from the Ministry of Food and Drug Safety of Korea, as satisfying the conformity assessment requirements of the MDACS. The trial will last from 1 October 2019 to 31 March 2020 for a limited number of listing applications of Class II/III/IV general medical devices.
If you are interested in this trial, please click here to download the application form for this trial and refer to the “Guidance Notes for Listing Class II/III /IV Medical Devices”(Guidance Notes: GN-02) to fill in the form (except item 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 MDCO. Applicants are encouraged to provide softcopies of supporting documents in CD-ROM format as far as possible.
Medical Device Control Office
20 September 2019