South Korea - Draft Notice on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices

​The Ministry of Food and Drug Safety announced a draft notice to establish the “Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices,” following the implementation of the performance evaluation system under the In Vitro Diagnostic Medical Devices Act.

The draft defines key terms used for performance evaluation and sets detailed requirements beyond those already prescribed by law.

It allows applicable evaluation standards and methods to include standards under the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO/IEC, and test specifications established at the time of approval or certification, while also specifying the evaluation items to which these methods may apply.