On January 2, 2026, the Ministry of Food and Drug Safety (MFDS) of Korea announced a amendment to the Enforcement Regulation of the In Vitro Diagnostic Medical Devices Act.
The purpose of this amendment is to ensure the safety and improve the quality of in vitro diagnostic (IVD) medical devices by allowing the Minister of Food and Drug Safety to conduct performance evaluations on products that have received manufacturing licenses, certifications, or notifications; it also aims to define matters delegated by the Act and necessary for its implementation, such as the standards, methods, and procedures for performance evaluation, as well as the entrustment of related tasks.
The key details are as follows.
1) Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices
- Establishes standards and methods for performance evaluation, ensuring that factors such as accuracy, precision, and sensitivity are taken into account.
2) Procedures for Performance Evaluation of In Vitro Diagnostic Medical Devices
- A person who intends to undergo a performance evaluation of an in vitro diagnostic medical device shall submit the device, along with the specimens and reference materials required for the evaluation, to the head of the institution entrusted with the performance evaluation tasks.
- The head of the entrusted institution shall obtain prior approval from the Minister of Food and Drug Safety when charging fees for performance evaluation to the applicant and shall disclose the details of the approval on the institution's website.
3) Entrustment for Performance Evaluation of In Vitro Diagnostic Medical Devices
- The Minister of Food and Drug Safety may entrust tasks such as the performance evaluation of in vitro diagnostic medical devices and the management of specimens to designated clinical performance testing institutions, and in such cases, the name of the entrusted institution and the details of the entrusted tasks shall be announced on the Ministry's website.
Please refer to the attached document below.
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