South Korea Proposes Rules to Halt Manufacturing and Sales of Risky In Vitro Diagnostic Medical Devices

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On July 31, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) released a draft partial amendment to the Enforcement Rule of the In Vitro Diagnostic Medical Devices Act, scheduled to take effect on January 3, 2026. The draft outlines delegated matters such as performance evaluation criteria and methods, application procedures, and task entrustment. It aims to clarify evaluation standards and establish provisions for administrative actions based on the results of such evaluations.


Main Contents of the Draft Amendment

  • Performance evaluation: Evaluations will be conducted by the standards under the Medical Device Act and the detailed criteria and methods established by the MFDS Commissioner.
  • Application procedures: Applicants must submit technical documents, specimens, and reference materials to an entrusted institution. The institution will report the results to both the applicant and the MFDS Commissioner, and fees may be charged after being publicly disclosed in advance.
  • Administrative actions based on results: If risks are identified, the MFDS may order the suspension of manufacturing, import, or sales, require inspections or re-evaluations, or issue use suspension orders. Evaluation results may also be published on the MFDS website.
  • Entrustment of tasks: Performance evaluation tasks may be delegated to organizations or institutions with relevant expertise. The names of entrusted institutions and details of the tasks will be disclosed on the MFDS website.


Comments must be submitted by September 9, 2025, either online via the Integrated Legislative Information System or by sending a written opinion to the MFDS.


GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), or MFDS (Korean Medical Devices). For tailored certification and regulatory assistance, contact GCA Korea. We’re here to streamline your market access in South Korea.



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