The Ministry of Food and Drug Safety (MFDS) participated in the 26th General Assembly of the International Medical Device Regulators Forum (IMDRF) in Seattle, Wash., from Sept. 16 to 20 to promote cooperation with overseas medical device regulators and international harmonization of regulations.

IMDRF is a council of regulators from 11 countries, including the U.S., Europe, and Japan, who lead the international regulation of medical devices. Korea joined the organization in 2017 and served as its chair country in 2021.

This year’s IMDRF featured joint workshops with the international industry on developing the medical device regulatory system and presentations by each regulatory agency and partner organizations, including the WHO and IMDRF working groups on the current status of tasks. It also discussed plans to strengthen education for new member countries and IMDRF guidance training for partner countries.

The MFDS presented regulatory changes, including licensure management policy for the entire lifecycle from medical device development to post-market management, recent laws and guidelines to showcase the excellence of Korea's regulatory system, and the increased level of international harmonization.

During the event, the Korean regulator also strengthened its network with member countries to exchange the current status of medical device regulation. For example, it cooperated with Singapore’s Health Sciences Authority (HSA) to develop clinical trial design guidelines for AI medical devices and held a video conference with Australia’s Therapeutic Goods Administration (PGA) to share guidelines in the field of digital health.

“We will continue to actively participate in the IMDRF general assembly and working group meetings to promote the excellence of Korean medical devices by leading international regulations,” the ministry said.