"Leading Digital Health Regulation... MFDS Actively Engages in International Exchanges"

Published 11 Apr.2023 16:25(KST)

The Ministry of Food and Drug Safety (MFDS) announced on the 11th that it attended the '23rd International Medical Device Regulators Forum (IMDRF) General Assembly' held in Brussels, Belgium from the 27th to 31st of last month to contribute to international regulatory harmonization in the medical device field and to lead international regulations in the digital healthcare sector.

The Ministry of Food and Drug Safety announced on the 11th that it attended the 23rd International Medical Device Regulators Forum (IMDRF) General Assembly held last month in Brussels, Belgium.
[Photo by Ministry of Food and Drug Safety]

IMDRF is a consultative body of regulatory authorities from 11 countries, including the United States and Europe, leading international regulatory harmonization for medical devices. Korea joined in December 2017 and served as the chair country for one year in 2021.

At this IMDRF General Assembly, the MFDS conducted bilateral meetings with medical device regulatory authorities from IMDRF member countries such as Singapore, Canada, Australia, Japan, and Brazil to strengthen inter-country regulatory cooperation systems and expand Korea's regulatory influence. With the Singapore Health Sciences Authority (HSA), they shared approval and review standards for artificial intelligence (AI) medical devices and agreed to hold a webinar for the joint development of clinical trial guidelines to enhance mutual regulatory understanding. With Health Canada, they agreed to mutually review AI guidelines and include Korea's contributions in the guidelines published by Canada. With the Australian Therapeutic Goods Administration (TGA), they shared the current status and guidelines for in vitro companion diagnostic medical device approvals between the two countries and agreed to promote video conferences among working-level officials for collaboration such as analyzing regulatory differences.

Additionally, in bilateral meetings with Japan's Ministry of Health, Labour and Welfare and Brazil's National Health Surveillance Agency (ANVISA), Korea requested cooperation to join the 'MDSAP Working Group,' a working group for developing guidelines to apply a unified quality review program among IMDRF member countries, as an observer country. The MFDS plans to continue pursuing MDSAP membership to actively support the export of K-medical devices with excellent technological capabilities.

In particular, active exchanges on digital health regulatory status were held with the United States, Japan, Singapore, and others, and Korea expressed its intention to participate in the HBD public forum scheduled for the first half of next year. HBD is a joint research consultative body between the United States and Japan, established in 2003. Initially, discussions focused on cardiovascular medical devices, and recently, discussions in the pediatric field have been ongoing.

Furthermore, at this IMDRF General Assembly, the approval of two new and revised common cybersecurity guidelines for the safe use of medical devices was granted. In addition, in-depth discussions on the regulatory status of the digital healthcare sector between regulatory authorities and the international industry were conducted.

An MFDS official stated, "Attending this IMDRF General Assembly is expected to solidify the cooperative system with overseas medical device regulatory agencies and increase the influence of Korea's regulations in the digital health sector," adding, "We will continue to actively promote the MEGA project and GPS strategy to expand exports based on the excellent international competitiveness of K-medical devices and support the overseas advancement of promising domestic medical devices."

The MEGA project is a strategic export support policy for medical products that aims to discover and select product groups and items that can secure international competitiveness and lead the global market, providing intensive support throughout the entire cycle from product development to export. GPS stands for Global leader country advancement (G), Partnership expansion (P), and Supporter for export assistance (S) strategy.