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South Korea to help swift market entry of AI-enabled medical devices

( April 30, 2025, 03:36 GMT | Official Statement) -- MLex Summary: The South Korean government today announced planned revisions to the approval process for medical devices to facilitate swift market entry for those using artificial intelligence, or AI, and other advanced technologies while ensuring consumer safety. The revised regulation aims to help new device developers enter the market more quickly by obtaining approvals through strengthened clinical trials. It also enhances cybersecurity requirements and adds new types of medical devices into the category for prompt assessment, according to the Ministry of Food and Drug Safety. The ministry will accept public opinions until May 20. The statement, in Korean, is attached....

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