[Contribution] Is using a 0.2mm MTS device an ‘unlicensed medical practice’?

Legal guidelines for the aesthetics industry based on actual cases of non-delivery

Recently, in the aesthetic industry, there has been ongoing controversy over medical law violations surrounding cosmetic absorption enhancement procedures using MTS (Microneedle Therapy System) devices. In particular, confusion in the field is increasing because whether or not it is a medical practice can vary depending on the length of the needle attached to the device.

Accordingly, the author would like to address the legal issue of whether the use of 0.2mm MTS devices constitutes unlicensed medical practice under the Medical Service Act through a recent case that resulted in a decision by an actual investigative agency to not forward the case (no charges).

◆ Reconstruction of the incident: Blog ‘demonstration’ photo leads to accusation

The client, while running an aesthetic salon and conducting cosmetics education and online sales business, wrote a post on his personal blog to promote A cosmetics (main ingredients: hyaluronic acid, exisome, retinol). The problem started with the photo included in the post. The client created a scene where cosmetics were applied to the skin using an MTS device equipped with a 0.2 mm long needle.

This was a demonstration shot to show how to use the product, and there was no actual procedure performed on customers or other people. However, someone who saw this accused the client of violating the medical law, saying, 'A non-medical person used a medical device to practice medicine without a license.'

Accordingly, the defense lawyer launched a defense through a fierce legal battle, and the jurisdictional police station ultimately decided not to forward the case (no charges). What was the key legal issue that persuaded the investigative agency?

◆ First issue: 0.2mm needle and ‘medical practice’

The most important issue was whether the use of the 0.2mm MTS device constitutes a ‘medical practice’ prohibited by Article 27, Paragraph 1 of the Medical Service Act. The Supreme Court defines medical practice as 'an act of preventing or treating disease by performing examination, autopsy, prescription, medication, or surgical procedures with experience and skills based on medical expertise, as well as other acts that are likely to cause harm to health and hygiene if not performed by a medical professional' (Supreme Court 2008 Do277 ruling, etc.).

However, the Seoul Administrative Court recently ruled that the MTS procedure, which uses needles larger than 0.25 mm, is a medical practice that can cause health and hygiene hazards due to the possibility of infection (2023guhap83592). The above ruling determined that MTS devices with a needle length of 0.25 mm or more are medical devices, based on the fact that the Ministry of Food and Drug Safety's notice, 'Regulations on Medical Device Items and Grades by Item', classifies 'Drug Absorption Inducing Skin Stimulator' as a class 2 medical device.

If we interpret this logic in reverse, it means that devices with a needle length of less than 0.25 mm can be classified as 'home beauty devices' rather than medical devices. The 0.2mm needle creates a fine passage only in the stratum corneum of the skin to help absorb cosmetics, and is unlikely to cause any real risks such as bleeding or infection. Therefore, since this is an act for purely cosmetic purposes rather than a disease treatment, it is difficult to evaluate it as a medical act that is likely to cause health and sanitation harm if not performed by a medical professional.

◆ Second issue: ‘Demonstration’ is not ‘surgery’

In order for a violation of medical law to be established, an ‘act’ corresponding to the constituent elements must actually exist. Just staging and filming a specific scene for advertising purposes or demonstrating it for personal use cannot be considered as ‘practicing’ unlicensed medical practice as stipulated in Article 27, Paragraph 1 of the Medical Service Act.

In this case, the client simply 'directed' himself using the device to take pictures for advertising purposes, filmed it and posted it, or showed a demonstration for the customer to use for personal use.

In order for the investigative agency to prove the charges, it must reveal that the suspect received compensation from another person and performed unlicensed medical practice. However, the accuser only made a speculative accusation based on blog photos and failed to present evidence that could identify the actual victim or the specific facts of the crime. In the end, it is difficult to say that a simple demonstration was an act of violation of the Medical Service Act.

◆ Third issue: Whether or not it is unfair advertising under the Cosmetics Act

Article 13, Paragraph 1, Subparagraph 1 of the Cosmetics Act prohibits labeling or advertising that may misperceive cosmetics as medicines. However, the client's post was only intended to guide the effective use of A cosmetics, and did not claim medical efficacy such as treatment or prevention of disease. This is fundamentally different from cases punished for preventing hair loss or treating dermatitis, so it does not constitute unfair advertising that deceives consumers.

◆ The ‘safety line’ in the aesthetic industry must be maintained.

This decision not to forward the case leaves important implications for the aesthetics industry. First of all, the needle length of 0.25mm is an important baseline for medical judgment. If you use a needle smaller than 0.25mm, it can be recognized as a home beauty device and reduce the risk of violating medical laws. In addition, it is important to keep in mind that demonstrations showing how to use a product and actual procedures performed on customers must be strictly distinguished, and it is difficult to view the demonstration itself as a violation of medical law. In addition, care must be taken to clearly distinguish between instructions on how to use cosmetics and advertisements for drug efficacy to avoid unfair advertising under the Cosmetics Act.

Industry workers must clearly understand these legal principles and provide services within legal boundaries, such as providing guidance on the correct use of cosmetics using devices smaller than 0.25 mm. However, since the judgment of all cases may vary depending on the specific facts, it is recommended that when similar disputes arise, you must receive assistance from a legal expert to respond appropriately.
 

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[Contribution] Is using 0.2mm MTS device an 'unlicensed medical practice'?