How do I check whether a device or product used in a procedure is approved in Korea?
Product approval information can be looked up on the medical device information portal (의료기기안심책방) of the Ministry of Food and Drug Safety (MFDS). U.S. FDA clearance and Korean MFDS approval are different procedures, and the approved intended use can differ as well.
| Category | Who | What to look at |
|---|---|---|
| U.S. FDA 510(k)(a US FDA clearance confirming the device is equivalent to one already cleared) | U.S. Food and Drug Administration | Look up by K number · granted separately by device and intended use |
| Korean product approval | Ministry of Food and Drug Safety (MFDS) | Look up by product name or manufacturer on the MFDS medical device portal |
How to read the table
The table divides by who grants the approval. The U.S. FDA and Korea's MFDS are different procedures, and approval by one does not automatically mean approval by the other. That is why the two columns have to be checked separately.
What these figures do not mean
Approval does not mean 'safety is guaranteed'; it means 'use for this purpose has been reviewed'. So what to check is not only whether it is approved but for what purpose.
What makes the difference?
- 'FDA approved' alone is not enough — U.S. clearance is for the United States. For a device used in Korea, Korean approval status is a separate item to confirm.
- Approval is granted by purpose — Even for the same device, the approval records which area and which purpose it is for. You can compare whether the procedure you are having falls under that purpose.
- You need the product name to look it up — You can only search if you know the name of the device or product. Hearing at consultation what will be used, by name, is the first step.
The two approvals are different procedures
The U.S. FDA's 510(k) and Korea's MFDS product approval are systems of different countries with different review procedures. Approval by one does not automatically mean approval by the other, and the scope of the approved intended use can differ. Taking a description of 'FDA-approved device' as confirmation of Korean approval leads you astray.
Approval is granted by purpose
The approval records together which device is used for which purpose, and that combination is its scope. Even the same device may need a different approval for a different area or purpose. So what to check is not only whether it is approved but whether the procedure you are having falls under that purpose.
You need the name to look it up
The MFDS medical device portal (의료기기안심책방) is searched by product name or manufacturer. For that you need to hear at consultation, by name, what will be used. If a clinic does not give you the product name, it also means there is no way to confirm what the approval is for.
What to confirm at consultation
- The exact name of the device or product used
- Korean approval status and the approved intended use
- If U.S. FDA clearance is claimed, its K number
Asking about your own case
The table above gives general ranges and does not apply to you as it stands. Rephrasing the question like this at consultation gets you an answer for your own case.
What is the name of the device (product) you use? What purpose is its Korean approval for?
Common misunderstandings
If it's FDA approved, is it approved in Korea too?
No. U.S. FDA clearance and Korean MFDS approval are different procedures, and the scope of the approved intended use can differ. For a device used in Korea, Korean approval status has to be checked separately.
How do I look it up?
Search by product name or manufacturer on the MFDS medical device portal (의료기기안심책방). For that you need to hear at consultation the name of the device or product used.
Related questions
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Information verification
This page is general guidance based on material published by public bodies and professional societies; it is not information about any particular clinic. Page updated 2026-10-12. The sources are listed under References below.
References
- Ministry of Food and Drug Safety (MFDS) — Medical device product search
- U.S. FDA — Renuvion safety communication
This content is general information and does not replace a diagnosis or consultation with a medical professional. Whether it applies to you must be confirmed with a board-certified specialist.
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