MFDS Establishes Foothold for Digital Health Devices to Enter Global Market
The Ministry of Food and Drug Safety (MFDS) has taken steps to establish a foothold for entering the global market in the digital health device sector.
From the 6th to the 9th, the MFDS visited Singapore and held two cooperation meetings with the Health Sciences Authority (HSA), the ministry announced on the 12th. During the ‘MFDS-HSA AI Medical Roundtable Meeting,’ they examined differences in clinical trial verification methods for artificial intelligence medical devices between the two countries to jointly develop the ‘Guidelines for Clinical Trial Design of AI Medical Devices’ and discussed methods for developing joint clinical trial designs.
This meeting was arranged to specifically discuss the cooperation agreement made last December and this past March in the field of AI medical devices between the two countries.
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Additionally, on the 8th, the MFDS met with the Director of the Medical Device Division of the Singapore Health Sciences Authority and other officials to discuss future cooperation needs regarding generative AI such as ChatGPT and safety management measures for digital therapeutics.
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