What counts as overseas-use experience
On August 31, 2026, MFDS amended its medical-device post-market investigation provisions by adding Article 9 on exemptions. Notice No. 2026-63 took effect on publication. For a device subject to Korea’s investigation system, Article 9 explains how overseas evidence can support an exemption application.
The definition calls for sufficient support for safety and effectiveness after comprehensive consideration of overseas post-market clinical experience, safety information, and authorization and sales history. An overseas authorization is one part of that assessment. Clinical experience and safety information from actual use also matter.
Article 9 does not set a uniform minimum number of years of overseas marketing. The issue is what the accumulated experience establishes about safety and effectiveness, rather than duration alone.
This pathway belongs to Korea’s specific post-market investigation system. MFDS describes the system as covering categories including rare and newly developed devices, with investigation periods set by the authority within four to seven years after marketing. The agency’s explanation also identifies Medical Device Committee deliberation for the overseas-use exemption pathway. It does not create an automatic exemption for every imported device.
Two evidence groups, with alternatives within the first
Article 9(2) requires two groups of material: clinical or post-market research evidence, and overseas authorization, sales, use and adverse-event information. The groups need to be assessed together.
The first group can consist of foreign clinical material equivalent to the clinical-trial material identified in Article 26(1)(6) of the provisions on medical-device authorization, notification and review. Alternatively, it can consist of overseas post-market investigation and analysis of safety and effectiveness.
The alternative concerns the two research routes within the first group. Article 9 does not require both routes simultaneously. It also does not make an arbitrary sales record or a simple count of uses a substitute for clinical or post-market research material.
The second group concerns overseas authorization, sales and use information, together with analysis and evaluation of collected overseas adverse-event material. Article 9 incorporates the material specified in Article 6(1)(2) and (3); the cross-reference provides detail beyond the broad group name.
Article 6(1)(2) calls for analysis and evaluation of adverse-event information by characteristics of the people receiving the device, including age, sex and pregnancy status, and by use details such as purpose, duration, method and results. Article 6(1)(3) covers sales history, foreign authorizations and foreign actions concerning safety and effectiveness. Article 9 draws the corresponding overseas information into the exemption evidence.
An adverse-event total therefore does not by itself address the analysis requirement. The material needs to explain the populations and conditions of use associated with the events. Relevant safety or effectiveness actions taken abroad also fall within the referenced material.
What the amendment adds to the application decision
In its announcement, MFDS explains that specific criteria for deciding whether overseas-use experience could support an exemption had previously been lacking. Article 9 sets out both the recognition criterion and the submission categories. A claim of overseas experience needs support from those materials.
For registration teams, the distinction helps identify the research route for the first group and the overseas-use and safety information required for the second. Clinical and post-market researchers can assess whether existing studies contain safety and effectiveness investigation and analysis, and whether the available adverse-event information addresses the dimensions incorporated from Article 6. Research findings and safety information from actual use serve different evidentiary purposes.
Overseas authorization status, use experience and research evidence remain separate parts of the decision. An authorization certificate alone does not establish that Article 9’s material is complete. Clinical or post-market research also needs to be considered alongside the second evidence group and the deliberation outcome.
The amendment clarifies the application basis; the Korean authority still decides whether a particular device qualifies for exemption. Article 9 helps identify gaps in existing overseas evidence, but foreign marketing alone does not establish the exemption result.
Sources
- Supporting source[보도참고] 식약처, 희소의료기기 등 시판 후 조사 면제 기준 마련 (opens in a new tab)Ministry of Food and Drug Safety
- Primary official source의료기기 시판 후 조사에 관한 규정 (제2026-63호) (opens in a new tab)Ministry of Food and Drug Safety