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Seoul seeks to lead global regulation on AI medical devices

The Ministry of Meals and Drug Security has set about to grow to be a complicated regulatory company for synthetic intelligence-based medical gadgets.


Lunit INSIGHT MMG, an AI solution for mammography (Credit: Lunit)
Lunit INSIGHT MMG, an AI resolution for mammography (Credit score: Lunit)


The ministry stated it hosted the common assembly of the Synthetic Intelligence Working Group throughout the Worldwide Medical Gadget Regulators’ Discussion board (IMDRF) from Thursday to Saturday.


IMDRF is a consultative physique of regulatory authorities shaped to harmonize and unify worldwide laws on medical gadgets all through the complete cycle earlier than and after their growth and commercialization. Eleven nations, together with the U.S. and EU, are taking part in it. Korea served as a chair nation final yr.


In accordance with the ministry, the members in final week’s assembly examined mid- to long-term plans of the working group and proposals for figuring out new tips whereas discussing methods for cooperation with the working group for software program medical gadgets throughout the IMDRF.


The working group’s mid- to long-term plans contained its future roadmap, together with the reason of key phrases in 2022, regulatory designs, together with these to be modified and managed, in 2023, manufacturing and high quality management in 2025, issues to think about earlier than market launches in 2027, and the monitoring of precise use after advertising in 2027.


The ministry defined that it labored out the mid- to long-term plans, gathered 33 opinions from member nations from June and September, mentioned its enchancment plans, and exchanged views on tips wanted for every part on the assembly.


The Korean regulatory company expects the mid- to long-term plan to exert affect on the laws of AI medical gadgets not solely in Korea however in superior nations, such because the U.S., the EU, and Japan. Earlier, the ministry led the AI medical machine tips via the working group and had the IMDRF formally approve it as a standard worldwide guideline.


After internet hosting the working group assembly, a ministry official expressed confidence, saying, “It’s already well-known that AI medical machine is the world the place Korean can greatest excel others.”


Commenting on the examination of the mid- to long-term plans on the assembly, the official stated, “As IMDRF permitted AI medical machine tips in Could, a body has been made. What’s left is find out how to fill contents in it.”


In Korea, the ministry has additionally continued to publish and distribute tips on licensing AI medical gadgets and conducting medical trials.


Starting with the rule of thumb on AI medical machine approval and screening and assessing the effectiveness of AI-based medical gadgets in 2017, it printed the rule of thumb on a medical resolution assist system (CDSS) medical machine medical trial concerning coronary artery stenosis, breast most cancers, lung most cancers, lung nodules, and ischemic stroke in 2019.


In 2020, the ministry printed the rule of thumb on the protection analysis and medical trial plan evaluation of assistant software program regarding prostate most cancers, colon most cancers, and the detection and analysis of the mind picture.


In accordance with the ministry, it has permitted 139 AI medical gadgets – 124 for home manufacturing and 15 for import.

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