Digital Medical Products in South Korea Face New Compliance Requirements

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On August 6, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced a proposed partial amendment to the Enforcement Rules of the Digital Medical Products Act. This amendment seeks to establish detailed provisions delegated by the Act, including procedures and criteria for performance certification of digital healthcare devices, the development and implementation of distribution management plans, and the issuance of orders and public disclosure related to the recall, replacement, disposal, or suspension of sales.


Organizations or individuals wishing to provide feedback on the proposed amendment may submit their comments online via the Integrated Legislative Notice System or in writing to MFDS by September 15, 2025.


This rule will take effect on the date of its promulgation.


For more information, please refer to the link: Legislative Notice: Proposed Partial Amendment to the Enforcement Rules of the Digital Medical Products Act in South Korea


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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Tel. +82-31-360-8180
E-mail: forest.lee@gca-kr.com

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