Real-World Data Collection for High-Risk Implantable Medical Devices Now Allowed in South Korea

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The amended Enforcement Decree of the Medical Device Act took effect upon promulgation on July 22, 2025. Provisions related to processing personal information will come into force on August 1, 2025.


The amendment provides a legal basis for Korea’s Minister of Food and Drug Safety (MFDS) and local governments to process sensitive and personally identifiable information when necessary to collect, analyze, and evaluate real-world data generated during the use of certain medical devices. This change follows a revision to the Medical Device Act that enables the designation of devices requiring long-term follow-up due to frequent or serious adverse effects after insertion into the human body.


Personal information may also be processed when responding to adverse events, including reporting, recall, and notification involving patients who have used the relevant devices.


For any inquiries regarding medical device certification in South Korea, don’t hesitate to reach out to GCA KOREA. Our specialists are ready to offer timely and precise support throughout the certification and approval process.



Contact ⬇

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

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