“Is it approved?” — what those long numbers on Korean clinic materials actually mean

“Is this MFDS-approved?” is a reasonable question and one you should ask. But if you try to check, there is often nothing usable to check against.

Boxes and posters carry several long numbers with nothing indicating which is which — and frequently the licence number is not printed at all.

This is not usually clinics being deceptive; it is how the rules are built. Advertising review numbers must be displayed on the advertisement. Licence numbers need not be. So the review number is what you see, prominently, and it gets read as approval.

Writing eleven reference documents forced us to work this out product by product. What follows is what we found.

This is the least-known part. Not every aesthetic injectable is a medical device.

Products based on human acellular dermal matrix (hADM) — Re2O and CellRedM among the ones we stock — are classified as human tissue, not as medical devices. There is therefore no product licence, no requirement to submit pre-market clinical data, and no adverse-event reporting obligation.

Two things follow, and they need to be kept apart.

• “Not licensed” does not mean “illegal.” It is a different category governed by different legislation
• But the threshold of scrutiny is different. Steps a medical device would have had to clear were not required, so the published evidence can be correspondingly thin

Which is why, if you see “MFDS approved” attached to one of these products, it is not true. Our own references use no approval language for either of them.

The second common misreading. A product licence is an administrative judgement that safety and performance meet a standard — not a guarantee that the treatment produces a good result.

And a third: what is licensed and what is actually done can differ.

Radiesse, for instance, is properly licensed in Korea — but the Korean licensed indications are only two: temporary improvement of facial wrinkles, and volume restoration of the dorsal hands. The jawline and décolleté indications approved in the United States fall outside the Korean licence. Treating those areas is not itself wrong, but describing it as an approved indication is inaccurate.

Licensed names also diverge from market names. The MFDS licence for Oligio Kiss is under “The Great RF Sonata.” Search the market name and you will find nothing.

Exactly as we found it while writing the references. Where we could not verify something, we say so.

Korean medical device licensing data is public and anyone can search it.

• MFDS medical device e-civil complaint portal (emedi.mfds.go.kr) — search licences by product or company name
• Medical Device Information Portal (udiportal.mfds.go.kr) — a more consumer-friendly search

Two things to remember: search the licensed name rather than the market name (Oligio Kiss being the example), and human-tissue products will not appear, because they are not medical devices.

These sites are reorganised from time to time. If you cannot find something, mention it at consultation.

Rather than “is it approved?”, three narrower questions get you far more.

1. First“Is this a medical device or human tissue?”This alone decides whether the concept of licensing even applies.
2. Second“What is the licensed indication?”Often more useful than whether it is licensed at all — it tells you whether the area you want treated falls inside it.
3. Third“Is there a study on this product?”Approval and evidence are separate matters. Class-level research is frequently presented as evidence for a specific product.

If the answer to the third is “there is class-level research but no study on this product”, that is a good sign, not a bad one. For a great many products it is simply the truth.

Written and reviewed by Lee Chi-Hak, MD, medical director of Miso Clinic in Daegu, South Korea. The tables above reproduce what we established product by product while writing the eleven documents in our clinical reference library. Where verification was not possible, it says so.