Jeheo · suheo · certification — what one line of approval number can and cannot tell you

The branches laid down by the Medical Devices Act run along two axes.

• Article 6(2) — where it is made in Korea: manufacturing approval · manufacturing certification · manufacturing notification
• Article 15(2) — where it is brought in from outside: import approval · import certification · import notification

So the six markings used in practice correspond like this.

The correspondence between class and procedure is in Article 4 of the Enforcement Rule of the Medical Devices Act. But it is not a rule that divides cleanly — paragraph 2 of the same Article leaves some class 2 devices subject to manufacturing approval. So it is wrong to read it as “certification always means class 2”.

We should state what we were not able to verify. A provision of law that itself lays down the Korean abbreviations such as “jeheo” and “suheo” we did not find. The official approval certificate at attached Form No. 4 of the Enforcement Rule of the Medical Devices Act leaves the number field as a blank, “No. ___”, and handles whether it is manufacture or import through a separate ‘category’ entry field. We checked five items of legislation · notification · MFDS guidance, and there was no wording prescribing the prefix marking. It appears to be a practice of administrative allocation, and if we find a source document we will amend this article. Nor did we find wording establishing whether the first two digits of the number (for example “14”) mean the year of approval.

This part is the most useful in practice. If you ask at a clinic to be shown the product box, the number is there. That is not a courtesy but a required particular laid down by law.

Article 20 of the Medical Devices Act (particulars to be entered on containers and the like) — “A manufacturer or importer of medical devices shall enter the following particulars on the container or the outer packaging of the medical device.”

Subparagraph 6 is particularly useful. Just by seeing whether the words “medical device” and a number appear together on the box, you can tell at once whether or not the product is approved as a medical device.

Before a procedure Miso Clinic checks the markings on the product we actually use together with you. This is what we call our ‘checking system’, and the provision above is its basis.

There is a route the MFDS itself has set out. “What are the precautions when having a cosmetic filler procedure?” (Ministry of Food and Drug Safety, 6 March 2019) put it like this.

“① MFDS website > Legislation/Materials menu > medical device electronic civil petition window ② Information menu > product information room ③ product information > search ‘biomaterial for tissue restoration’”

At present there are two gateways, the medical device electronic civil petition window (emedi.mfds.go.kr) and the medical device information portal (udiportal.mfds.go.kr), and you can search by product name · company name · model name · product approval number and the like.

The items you see when you look it up

The same information is also published as open public data, so it is clear what the published items are.

That ‘intended use’ is a published item is the heart of it. It means you can read exactly what the product was approved for in the original text rather than in an advertisement.

What is entered on an approval certificate is this — the product name, the classification number and class, the shape and structure, the raw materials or ingredients and quantities, the method of manufacture, the performance and intended use, the method of use, the precautions in use, the packaging unit, the storage method and shelf life, the test specifications, the manufacturing source, and the conditions of approval.

Medicines are looked up separately at Drug Safety Korea (nedrug.mfds.go.kr). Even for the same ingredient there are cases where one product is approved as a medicine and another as a medical device, so you have to check which it is and search in the place that fits.

What is examined in the approval review is set out as a list in Article 9(2) of the Enforcement Rule of the Medical Devices Act.

And the proviso to the same paragraph reads as follows.

“In the case of a medical device that is substantially equivalent in structure · principle · performance · intended use and method of use and the like to a medical device already approved or certified, among (…) medical devices, the data under subparagraphs 5 to 7 need not be submitted.” — the proviso to Article 9(2) of the Enforcement Rule of the Medical Devices Act

Subparagraph 6 is the data on clinical trials. That is, once a device is recognised as substantially equivalent to an existing product, it can be approved without data on clinical trials.

The definition of an ‘equivalent product’ is in an MFDS notification — “a medical device equivalent in intended use, principle of action, raw materials, performance, test specifications and method of use and the like to a medical device already approved · certified” (the Regulation on Approval · Notification · Review of Medical Devices, Article 2, subparagraph 12).

There is a device that pulls this back as well. The proviso above carries the condition that it excludes “medical devices for which the Minister of Food and Drug Safety determines and gives notice that the submission of data on clinical trials is necessary”. Even where a device is equivalent, if it is an item the MFDS has designated, clinical data must be submitted.

So this is how to read it

There is an approval number = the safety and performance within the scope of that intended use passed a review. This much is certain.

There is an approval number ≠ a clinical trial in people was done with that product. It may have been done and it may have been exempted, and the number alone does not distinguish between them.

Nor is the reviewing body a single one. The technical documentation for an equivalent medical device is reviewed not by the MFDS but by a designated technical documentation review body (Enforcement Rule Article 9(1), Article 15-2). It means that several routes are mixed together in the single phrase “MFDS approval”.

One sometimes hears it said that “it is class 4, so it is a better product”. But what the law sets the class by is written out in the provision itself.

“The Minister of Food and Drug Safety shall classify and designate (…) classes according to differences in the intended use of the medical device and the potential risk to the human body in use and the like.” — Article 3 of the Medical Devices Act

That the class is high means “the potential risk to the body is great”, not that the quality is superior. The reason fillers and skin boosters are class 4 is that they are put into the body and left to stay there.

In practical terms, though, it does mean something. The higher the class, the heavier the review procedure and the greater the likelihood that the MFDS reviews it directly. So it is accurate to read it not as “class 4, so it is good” but as “class 4, so it was examined more strictly”.

Not every product has a product approval number. There are cases where the system itself has no such number.

Cosmetics

Article 3 of the Cosmetics Act provides for ‘registration’ of a cosmetics responsible distribution business — it registers the business operator, not the product. Review at the level of the individual product exists only for functional cosmetics (Article 4), and even that is not ‘approval’ but ‘review or report’. For ordinary cosmetics there is no prior review at all.

The concept of a product approval number therefore does not exist for cosmetics. To say of a preparation distributed as a cosmetic that “we checked the approval number” does not hold.

Human tissue

The approval that arises under the scheme of the Act on Safety and Management of Human Tissue is tissue bank approval. Looking at the MFDS notification (the Regulation on Approval of Tissue Banks and Safety Management of Human Tissue), the subject of approval under Article 3 is “a person who intends to establish a tissue bank”, that is, an institution. What is entered on the approval certificate is likewise the name · representative · medical manager of the tissue bank, and there is no concept of approval at the level of the individual product.

The way things are marked differs too. Human tissue carries, instead of a medical device approval number, a tissue standard code and a barcode — unique numbers for identifying the individual tissue (Article 17-2 of the same Regulation).

This is not a story about which is better but a story about the systems being different. Human tissue has its own tissue bank management scheme and its own infection testing scheme, and material of the same class has long been used in burn treatment and breast reconstruction surgery. But it is as well to know that the phrase “there is an approval number” points to different things in the two systems.

That the intended use is a published item means that you can also check what uses are not approved. The MFDS has itself given examples.

“Uses that are not approved include ▵breast (chest) augmentation ▵augmentation of the volume of body parts such as the buttocks and calves ▵grafting of bone, tendon, ligament and muscle. To date the MFDS has approved no product for the above intended uses.” — Ministry of Food and Drug Safety, 6 March 2019

The structure of the law is this.

• Article 26(1) of the Medical Devices Act — a medical device without approval · certification · notification must not be “repaired · sold · leased · given or used”. Because ‘use’ is specified, medical institutions are directly subject to it as well.
• Paragraph 2, subparagraph 1 of the same Article — a medical device differing from the approved content must not be manufactured · imported · sold · leased.

To put it together, using a product that has no approval at all and using a product that has approval but outside the approved use are legally different matters. The first is directly prohibited down to ‘use’ by Article 26(1); a provision directly prohibiting the second as against medical institutions we did not find. In the reimbursed sphere, Ministry of Health and Welfare Notification No. 2020-104 (in force from 1 June 2020) lays down a separate procedure for use of treatment materials beyond the scope of approval.

Aesthetic procedures are for the most part non-reimbursed and so appear to fall outside the scope of that notification, but a primary source stating that expressly we were not able to verify.

We will give one example that we actually checked.

Looking at the Korean official site of a poly-L-lactide preparation in wide use in Korea, this is what is written.

The number written on the site is a number showing that the advertisement was reviewed, not a number showing that the product was approved. Both are numbers that involve “the MFDS”, so they are easy to confuse, but they are entirely different systems.

If you would like to look at this distinction in more detail, we have written it up in What the approval numbers in clinic materials mean.

There is a reason we have not written the product approval numbers of individual products in this article. It is that we were not able to access the MFDS lookup system directly and verify them in the original. Copying across numbers floating about on the internet can be wrong, so we have kept to the principle of writing only what we verified. At consultations with the director we check the markings on the actual product together with you.

Three things are all you need to do in the consulting room

1. Ask to be shown the product box. The words “medical device” and a number have to be there — they are required particulars laid down by law (Article 20).
2. Look up the intended use by the number. What the product was approved for comes up in the original text.
3. Ask separately whether there are clinical trial data. The number alone will not tell you.

Miso Clinic takes it as a principle to show you these three things before you ask. It is not a difficult thing to do, and once you have checked, deciding on a procedure becomes a great deal easier.

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.