MFDS Participates in Medical Device Regulatory Harmonization Meeting... "Exploring Export Strategies for Domestic Medical Devices"

The Ministry of Food and Drug Safety (MFDS) announced on the 27th that it will attend the 27th Annual General Meeting of the International Medical Device Regulators Forum (IMDRF) held in Shanghai, China from the 27th to the 30th, to promote Korea's medical device regulatory system and explore ways to support the export of domestically produced medical devices.

The IMDRF is a cooperative organization involving 33 member countries including the United States, China, and Singapore, aimed at harmonizing medical device regulations. It operates a Technical Committee and eight working groups.

The MFDS currently holds the chairmanship of the Strategic Advisory Group and Working Group 1 (WG1) within the IMDRF, helping domestic products enter the global market through regulatory harmonization. The MFDS also served as the chair country of the IMDRF from 2015 to 2017.

At this meeting, the MFDS plans to present cases of artificial intelligence (AI) medical device regulations, directions for innovative medical device regulations, and market entry achievements. Additionally, it will request approval for three internationally common guidelines revised under the leadership of the MFDS, including regulatory application of electronic user manuals, medical device modifications, and conformity assessment of companion diagnostic medical devices.

Furthermore, the MFDS will seek cooperation measures in the digital health sector through bilateral cooperation meetings with regulatory authorities from various countries attending the general meeting.