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<p>In a significant development, Korea’s Ministry of Food and Drug Safety (MFDS) has emerged as a prominent player in global medical device regulation. At the 24th General Assembly of the International Medical Device Regulators Forum (IMDRF) held in Berlin from September 25 to 29, 2023, MFDS showcased its leadership by actively participating in discussions on AI-based medical devices and digital health. This move underscores Korea’s commitment to spearheading the development of international guidelines in these emerging sectors.</p> 
<h2 class="wp-block-heading" id="imdrf-leading-global-regulatory-harmonization">IMDRF: Leading global regulatory harmonization</h2> 
<p>The IMDRF comprises 11 countries, including the United States and Europe, which is pivotal in coordinating international regulatory harmonization efforts for medical devices. Korea joined this esteemed organization in December 2017 and assumed the role of its chair country in 2021, marking a significant milestone in its commitment to global health device regulation.</p> 
<h2 class="wp-block-heading" id="global-dialogue-on-digital-health-regulations">Global dialogue on digital health regulations</h2> 
<p>At the General Assembly, delegates from member countries engaged in a comprehensive dialogue on various aspects of medical device regulation. Key topics included the current regulatory landscapes in different nations, the introduction of expedited review mechanisms, and collaborative initiatives between the IMDRF and the Global Harmonization Working Party (GHWP), an intergovernmental organization with 33 member countries dedicated to harmonizing medical device regulations worldwide.</p> 
<h2 class="wp-block-heading" id="korea-s-emphasis-on-ai-and-digital-health">Korea’s emphasis on AI and digital health</h2> 
<p>During the General Assembly, MFDS highlighted the pressing need for international collaboration, particularly in the field of artificial intelligence (AI) in healthcare, where Korea has been making significant strides. Korea advocated for joint efforts in developing guidelines to ensure the safe and effective deployment of AI-based medical devices worldwide. The nation also shared examples of domestic regulatory innovations and outlined the progress made in enacting and revising domestic laws and guidelines, showcasing the excellence of its medical device regulatory system and products.</p> 
<h2 class="wp-block-heading" id="panel-discussions-focus-on-patient-groups-and-digital-therapeutics">Panel Discussions focus on patient groups and digital therapeutics</h2> 
<p>In panel discussions, the Korean regulator put forward its policies concerning rare and urgently needed medical devices, specifically emphasizing patient groups with unique requirements. They also delved into the distinctive features of digital therapeutic devices and discussed the relevant regulatory frameworks. This proactive participation from Korea reflects its commitment to shaping regulations catering to the evolving medical technology landscape.</p> 
<h2 class="wp-block-heading" id="korean-companies-innovative-contributions">Korean companies’ innovative contributions</h2> 
<p>Welt and Aim-Med, prominent Korean companies in the medical device sector, were also present at the General Assembly. They shared insights into Korea’s innovative medical device designation system for digital therapeutic devices and presented the outcomes of clinical trials on their cutting-edge medical devices. These contributions from Korean companies showcased the nation’s commitment to pushing the boundaries of medical technology and promoting global collaboration.</p> 
<h2 class="wp-block-heading" id="korea-s-aspiration-to-join-the-medical-device-single-audit-program-mdsap">Korea’s aspiration to join the Medical Device Single Audit Program (MDSAP)</h2> 
<p>During the event, MFDS sought cooperation and support from Japan and Australia for Korea’s transition to becoming an observer of the Medical Device Single Audit Program (MDSAP). The MDSAP, a joint audit program involving five full member countries, including the U.S. and Japan, enables the mutual recognition of manufacturing quality control audits conducted in each country. Having joined as a cooperating member in 2019, Korea aims to ascend to full membership status through its observer status. This move signifies Korea’s commitment to ensuring the highest medical device manufacturing and quality control standards.</p> 
<h2 class="wp-block-heading" id="continuing-global-cooperation">Continuing global cooperation</h2> 
<p>The Ministry of Food and Drug Safety affirmed its commitment to fostering greater cooperation among nations in medical devices. To achieve this, it plans to conduct online briefings and joint workshops, facilitating a better understanding of regulatory systems and creating opportunities for collaboration. The MFDS also expressed its hope that the IMDRF General Assembly would catalyze enhancing the influence of Korean regulations on the global stage, particularly through strengthening MDSAP activities.</p> 
<p>Korea’s active participation in the IMDRF General Assembly reflects its growing prominence in global medical device regulation. With a focus on AI-based medical devices and digital health, Korea is taking the lead in shaping international guidelines and fostering cooperation among nations. As it continues to champion innovation and safety in the medical device sector, Korea’s contributions are set to play a pivotal role in shaping the future of healthcare technology worldwide.</p>

Korea’s Drug Regulator Takes Lead in Shaping AI and Digital Medical Device Guidelines

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