Korea MFDS Proposes Regulations on Standards and Methods for Performance Evaluation of IVDs

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As the performance evaluation system for In Vitro Diagnostic Medical Devices (IVDs) has come into effect, the Ministry of Food and Drug Safety (MFDS) plans to establish the “Regulations on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices” (Announcement No. 2026-236) in order to provide detailed criteria beyond those specified in the relevant regulations. Public comments on the proposed regulations will be accepted until June 4, 2026.


Korea MFDS in vitro diagnostic medical devices

Definitions
  • Defines the terms used in this regulation for the performance evaluation of In Vitro Diagnostic Medical Devices (IVDs).

Standards and Methods
  • Provides for the application of standards and specifications under Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO and IEC, and test specifications established at the time of approval or certification of In Vitro Diagnostic Medical Devices (IVDs) as standards and methods for performance evaluation.
  • Specifies in detail the evaluation items to which the standards and methods for performance evaluation may be applied.

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