Korea to chair working group on regulating AI medical device

03-Jul-2020 Intellasia | KoreaBiomed | 6:02 AM Print This Post

The Ministry of Food and Drug Safety said it has been elected as the first chair of Artificial Intelligence Medical Devices (AIMDs), at a meeting of the International Medical Device Regulators Forum on June 25.

The forum, launched in 2011, is a voluntary group of medical device regulators from 10 member states, including the United States and European Union, which leads the international regulatory harmonisation and optimisation of medical devices. Korea joined the forum in December 2017.

AIMDs plans to establish various international guidelines, such as the definition and application of artificial intelligence (AI) medical devices, under the Korean ministry’s auspices. It has been making various efforts to support the development of medical devices based on AI and create a leading regulatory environment.

In 2017, the ministry unveiled six rules, including guidelines for the world’s first AI medical device permit and examination, which became the basis for approving 36 AI devices made by 15 Korean companies.

The ministry also promoted and supported innovative medical device industries and product development by, for instance, pushing for the legislation of the Medical Devices Industry Development and Innovative Medical Devices Support Act, or Medical Devices Industry Act.

“The winning of the working-group chairmanship is the result of the international recognition of the nation’s regulatory capacity of AI medical devices,” minister of Food and Drug Safety Lee Eui-kyung said. “It will also help to strengthen the export competitiveness of the domestic medical device industry.”

Lee added that her ministry would also push for cooperation with the World Health Organization and the International Electrotechnical Commission to emphasize the role of Korea in harmonising international medical equipment regulations.

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Category: Korea

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