On March 30, 2026, the Ministry of Food and Drug Safety (MFDS) of Korea announced a draft partial amendment to the Regulations on Approval, Notification, and Review of Medical Devices.
The proposed amendment aims to reduce administrative and financial burdens in the medical device approval process by expanding the scope of acceptance for real-world evidence (RWE) as clinical data and abolishing the notarization requirement for translated documents in languages other than English.
The key details are as follows.
1) Expansion of the scope of acceptance for RWE as clinical data.
- Currently, RWE may be used in place of clinical trial data for certain categories, such as rare or urgently needed medical devices, 3D-printed medical devices, and devices incorporating digital technologies (e.g., big data, AI). The amendment proposes to expand this scope to also include cases where modifications to existing medical devices are intended.
2) Abolition of the notarization requirement for translations of non-English materials
- Previously, when submitting documents in languages other than English for medical device approval or certification, applicants were required to provide notarized full translations. The amendment proposes to replace this requirement with a confirmation by the manufacturer attesting to the accuracy of the full translation.
Please refer to the attached document below.
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