Domestic and export-only — the same-looking approval number, a different standing

Here are two products approved under the same item name (tissue-filling biomaterial, class 4), side by side. This is the result of looking them up directly on 4 September 2026 in the MFDS medical device information portal (emedi.mfds.go.kr, known in Korean as 의료기기안심책방).

You cannot tell from the number alone. Both are “Je-heo 26-6xx” and both have an item status of “Normal”. We wrote in the two preceding pieces that you should check the approval number, but the mere fact that a number exists does not tell you whether the product can be used in Korea. You have to look at one more field.

As an incidental clue, whether a standard code (UDI) is attached also differed. The standard code applies to medical devices distributed · sold in Korea, while export-only products may follow the standards of the destination country. But we checked only two, so please use this as a supporting clue only.

On the same day we counted the whole set of items returned by a search for “tissue-filling biomaterial”.

Three out of every four are export-only. This is not a number produced by anyone doing something wrong; it appears to be the result of how the framework is designed. For a medical device intended solely for export, part of the documentation to be submitted is waived, and the applicant is required to enter “for export only” in the remarks field of the application. A class 4 approval for domestic sale requires clinical data, whereas the burden for export-only is far lighter. From a manufacturer's point of view the cost of entry does not compare.

Put the other way round, it runs like this. An export-only product is a product that has not been reviewed for domestic sale. What was waived is precisely the material that confirms safety · performance. We wrote in the preceding piece that “approval is not a guarantee of efficacy”; for export-only products the threshold of that approval is itself different.

One thing as you read the number — this is a count of items, not of actual distribution. It does not mean that all 745 are circulating in the market. But the very fact that this many export-only items are entered on the Korean approval register is what creates the need for a patient to check.

The sentence of Article 26 (Prohibition of General Acts), paragraph 1 of the Medical Devices Act runs like this.

“No person may repair, sell, lease, transfer or use a medical device that has not obtained approval or certification or has not been notified … nor may any person manufacture, import, repair, store or display such a device for the purpose of selling, leasing, transferring or using it.”

Two things to look at here. First, the subject is “no person”. Not only manufacturers and distributors but the person who used it is included. Second, the only exception in the proviso is “for the purpose of display at a fair · exhibition · trade show and the like”, and there is no exception relating to export.

A product approved “for export only” is a medical device that has not been approved for domestic sale, so using it in Korea falls within “using a medical device that has not been approved” under the article above. The MFDS answers in its FAQ that “an export-only medical device is a product approved solely for export and not for domestic sale, so separate approval · certification must be obtained if domestic distribution is desired”, and it takes the view that displaying · promoting a product at a domestic trade show also constitutes “domestic distribution”.

Some material on the internet still gives the upper limit of the fine as 20 million won. That is the former text. The current text we confirmed is 50 million won. Still, statutes are amended, so this paragraph is as of 4 September 2026, and if you have occasion to cite it, please re-check the current text on the National Law Information Center.

The conclusion that it cannot be used on a patient in Korea is the same for all three, but what you see on the lookup screen is entirely different.

The middle row is the most confusing one. An export-only product looks entirely unproblematic — it has a proper number and its item status is “Normal” too. It only comes out when you open the detailed information and look at one more field.

Anyone can do it on the MFDS medical device information portal (emedi.mfds.go.kr). No account is needed.

If you were not given an approval number, you can search by model name, and there is also a function that looks the product up from a photograph of the barcode on the box. Opening [Expand search conditions] on the search screen lets you filter on “Export only” itself (though it has to be used together with a search term).

“It does not come up” does not mean it is illegal

This is a trap we ran into ourselves. Brand names generally do not come up. We put well-known filler brand names into the name field and into the product name field of the expanded conditions, and got 0 results. The reason is that the “product name” field in the detailed information is empty for many items — the domestic product we looked at above had a blank product name too. So a brand name not coming up is a common thing and proves nothing in itself. Always look it up by approval number.

There is one more limit to the lookup. What the lookup tells you goes as far as “whether the product with that approval number can be used in Korea”. Whether what is actually in the syringe in front of you is really that product is not something a lookup can tell you. There is also the option of reading the Korean labelling, but if the clinic opens the original packaging and uses it, the patient has no chance to see it. This is a fundamental limit of the method, and it is why we do not write “check it and you can relax”.

Under Article 20 of the Medical Devices Act, there are things that must be written on the container or outer packaging of a product distributed domestically.

So if there is no Korean labelling at all, or there is no original manufacturer · Korean approval number · Korean expiry date and everything is printed in a foreign language only, there is a possibility that the product is not labelled for domestic distribution. But this is a clue and not proof — if the clinic opens the box and uses it you cannot see it, and to check you end up back at looking up the approval number.

This comes out of the same article. Neither a clinic nor an individual may use in Korea a medical device bought directly from overseas. Importing is something that a person holding an import business licence is to do, and a product that did not come in that way becomes “a medical device that has not been approved”. The same applies even if you bought it for your own use, on the MFDS's interpretation.

Buying a device you like on the spot at a trade show is not allowed either. As we saw above, the only exception in Article 26(1) is “for the purpose of display”, not sale or purchase.

In March 2025 the MFDS announced that, together with consumer groups · associations, it would build a standing monitoring system for the illegal distribution of medical devices bought from overseas. The items mentioned as having been caught were laser hair-removal devices · blood pressure monitors · cupping devices · anti-snoring devices · anti-bruxism devices · nebulisers and the like.

We will write this honestly. We did not find a published case of enforcement · sanction of the type “a Korean clinic or hospital performed a procedure on a patient with a device approved for export only”.

That does not mean “such a thing does not happen”. There appears to be a structural reason — the MFDS's public notices of administrative sanctions on medical devices are directed at manufacturers · importers · distributors, and a medical institution is a “user” under the Medical Devices Act and so is not a subject of those sanctions. Sanctions on the medical institution side go down the criminal route, and that is not tallied in a public database. So it is not confirmable from public material is the accurate way to put it.

The judgments we did confirm are somewhat different in character. In a case involving the distribution of laser devices and the like imported without approval, Article 26(1) was applied and a suspended prison sentence and confiscation were handed down. And in a case under the Pharmaceutical Affairs Act, concerning medicines rather than devices, a ruling came in 2024 and 2025 that “where a manufacturer transfers ownership to a domestic exporter for consideration, that constitutes a sale even if the goods are to be exported in future”. Because it is not a medical device case it cannot be carried across as it stands, but the direction — that “even something made for export becomes a domestic sale if it changes hands in Korea” — is worth noting.

We would rather this piece were not read as “be suspicious of your clinic”. Article 20 of the Medical Devices Act places the duty of writing the approval number on the product container · outer packaging on the manufacturer · importer. If a product came through normal distribution, the clinic is in a position to be able to check that number.

So “please tell me the product's approval number” is not an unreasonable request but an entirely normal verification step. That is particularly so for class 4 products. If you ask us, we will tell you. And we mean to raise it in consultation before you ask.

The two preceding pieces in this series are worth reading alongside — what the approval number in a clinic's material means covers the difference between a marketing approval number and an advertising review number, and Jeheo · suheo · certification covers what a single line of a number can and cannot confirm.

The one line this piece is meant to leave. Having an approval number and being usable in Korea are two different things. Verification is not one line of a number but three fields — the number + the item status + Export only.

Written and reviewed by Lee Chi-Hak, MD, medical director of Miso Clinic in Daegu, South Korea. Every study cited above is given together with its design, its size and the limitations the authors themselves recorded, and where we could not find data, we have said that we could not find any.