South Korea sets management system guidelines in AI-applied medical products sector
( August 12, 2026, 01:31 GMT | Official Statement) -- MLex Summary: South Korea’s Ministry of Food and Drug Safety said Wednesday that it has published guidelines setting out detailed application and evaluation procedures for excellent management system certification under the Digital Medical Products Act. The guidelines are aimed at supporting the certification system, which recognizes companies with strong capabilities in the development, maintenance and safety management of digital medical devices in line with advances in artificial intelligence technology. Companies that receive the certification may be exempt from submitting certain documents when applying for regulatory approval or may be allowed to submit alternative documents, the ministry said.The statement is attached (in Korean)....
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