The Ministry of Food and Drug Safety (MFDS) announces its collaboration with major tech players in its latest initiative, the Big Tech Regulatory Innovation Program 2024, aimed at bolstering regulations in the digital healthcare sector. Building upon the success of last year’s program, this iteration sees the inclusion of four prominent companies: Samsung Electronics, Samsung Fire and Marine Insurance, Hyundai Motor, and SKT.

To refine regulations surrounding artificial intelligence (AI)–based medical devices, the MFDS initiated the Big Tech Regulatory Innovation Program last year. This year, the focus remains on advancing regulations pertinent to AI medical devices, emphasizing generative AI medical devices (AIMDs).

Identification of key tasks

Through collaborative efforts between the MFDS and participating tech giants, five crucial tasks regarding AIMDs have been identified. These include streamlining clinical standards, establishing robust screening criteria, facilitating rapid commercialization, offering support for overseas market expansion, and advocating for the use of real-world data and evidence in domestic approvals.

Expanding its regulatory scope, the MFDS plans to extend its improvement targets to encompass digital and AI medical devices. This strategic move underscores the commitment to fostering innovation and ensuring regulatory alignment with technological advancements.

Commencing this month, the MFDS will engage in comprehensive discussions with each participating company to gain insights into their progress and plans. These engagements will serve as a platform to identify additional regulatory improvement opportunities and foster collaboration toward achieving common goals.

Scheduled visits and ongoing dialogue

The MFDS is scheduled to conduct site visits to all participating companies, starting with Samsung Fire and Naver in March. Subsequent visits are planned for Kakao Healthcare, Kakao Brain, KT, LGU+, Samsung Electronics, Hyundai Motor, and SKT in April. These visits will occur biannually, ensuring continuous dialogue and progress assessment.

With a forward-looking approach, the MFDS aims to cultivate a regulatory environment conducive to innovation within the domestic market and on a global scale. By aligning local regulations with international standards, Korean companies are poised to lead the global digital medical device market.

The Big Tech Regulatory Innovation Program 2024 signifies a collaborative effort between the MFDS and major tech entities to drive regulatory advancements in the digital healthcare landscape. The program aims to foster innovation through dialogue, engagement and targeted initiatives while ensuring patient safety and regulatory compliance. As the digital healthcare sector continues to evolve, such initiatives play a pivotal role in shaping the future of medical technology and its regulatory framework.

The partnership between regulatory bodies and tech giants heralds a promising era of innovation and regulatory alignment in the digital healthcare domain, propelling Korean companies to the forefront of the global market.

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