On May 15, 2026, the Ministry of Food and Drug Safety (MFDS) has announced the draft Regulation on the Criteria and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices.
The purpose of this proposed regulation is to prescribe the necessary details regarding the criteria and methods for the performance evaluation of in vitro diagnostic medical devices, in accordance with the implementation of the performance evaluation system, in addition to matters specified by relevant laws and regulations.
The key details are as follows.
1) Definitions
- Provision of definitions for terminology used throughout this regulation regarding the performance evaluation of in vitro diagnostic medical devices.
2) Criteria and Methods
- Permissible standards for performance evaluation, including: Standards pursuant to Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards (ISO, IEC, etc.), and test specifications established during the initial approval or certification of the device.
- Specification of detailed evaluation items applicable to the established criteria and methods.
Public comments on the draft amendment will be accepted until June 4.
Please refer to attached document below.
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