The Medical Device Division (MDD) (formerly known as Medical Device Control Office (MDCO)) will continue the 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 Korea Ministry of Food and Drug Safety (MFDS). Thus, for applicant who provides marketing approvals from MFDS, they can proceed the application without providing the Medical Device Administrative Control System (MDACS) conformity assessment certificate issued by one of the Conformity Assessment Bodies (CAB).
The trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices.
The application form for the trial can be downloaded here, refer to the “Guidance Notes for Listing Class II/III /IV Medical Devices”(Guidance Notes: GN-02) to fill in the form (except items A003 and D001).
Continuance of 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)