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South Korea - Proposed enactment of the “Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices”
The Ministry of Food and Drug Safety of the Republic of Korea intends to enact the "Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices" to provide detailed matters necessary for the implementation of the performance evaluation system, as delegated under Article 17-3 of the “In Vitro Diagnostic Medical Devices Act” and Article 38-2 of the “Enforcement Rule of the In Vitro Diagnostic Medical Devices Act” to include the following:
A. Provide definitions for terms used in this Regulation for the performance evaluation of in vitro diagnostic medical devices.
B. Establish standards and methods for performance evaluation by applying the standards and specifications prescribed under Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO/IEC, and the test specifications established at the time of the permit or certification of the in vitro diagnostic medical device.
C. Specify evaluation items to which the standards and methods for performance evaluation shall be applied.
Source Link:
G/TBT/N/KOR/1354