The Ministry of Food and Drug Safety (MFDS) has participated in an international medical device regulatory consultative body to introduce domestic systems and propose joint development of international guidelines to lead international regulation on digital health, including artificial intelligence-based medical devices.
The ministry said Friday that it attended the 24th General Assembly of the International Medical Device Regulators Forum (IMDRF) in Berlin from Sept. 25-29.
The IMDRF is a group of regulators leading the international regulatory harmonization of medical devices. It is composed of 11 countries, including the U.S. and Europe. Korea joined the organization in December 2017 and served as its chair country in 2021.
The participants in the meeting discussed the regulatory status of each country, including the status of digital health regulations, introducing an expedited review system, and cooperation plans between the IMDRF and GHWP (Global Harmonization Working Party), an intergovernmental organization for the harmonization of medical device regulations with 33 member countries worldwide.
The MFDS stressed the need to strengthen cooperation between countries to jointly develop guidelines in AI, where Korea is showing its strengths. It also introduced examples of domestic regulatory innovations and the status of enactment and revision of domestic laws and guidelines to promote the excellence of the domestic medical device regulatory system and products.
In the panel discussion, the Korean regulator presented its policy on rare and urgently needed medical devices in the session for specific patient groups, the characteristics of digital therapeutic devices, and related regulations.
Some Korean companies, including Welt and Aim-Med, also attended the meeting, explaining the innovative medical device designation system for digital therapeutic devices in Korea and the results of clinical trials of their innovative medical devices.
During the meeting, MFDS also requested cooperation and support from Japan and Australia for Korea's transition to the observer of the Medical Device Single Audit Program (MDSAP).
MDSAP is a joint audit program comprising five full member countries, including the U.S. and Japan, which mutually recognize all or part of each country's audits in one manufacturing quality control audit. MDSAP members are divided into full, observing, and cooperating members. Korea, which joined as a cooperating member in 2019, aims to become a full member through an observing member.
The ministry said it would continue to promote the strengthening of cooperation between countries in medical devices through online briefings and joint workshops between countries to enhance the understanding of regulatory systems and discuss ways to cooperate.
"We expect the IMDRF General Assembly to serve as an opportunity to solidify the cooperation system with overseas medical device regulators and increase the influence of Korean regulations by, for instance, strengthening MDSAP activities," the ministry said.