South Korea Updates Medical Device Standards and Specifications in Line with IEC/ISO

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This notification shall take effect six months after its promulgation.


On August 27, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced amendments to medical device standards and specifications to align with international standards (IEC, ISO). The revision aims to enhance the safety and quality of medical devices and to prevent potential risks to public health proactively.


New standards were introduced for six product categories, including condensation silicone impression materials for dental use and high-intensity focused ultrasound surgical systems. Additionally, testing standards for 17 categories, including anesthesia gas machines and infant incubators, were revised to comply with IEC/ISO requirements.


Applications already submitted under the previous regulations will continue to be reviewed according to the former rules.


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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