How can a manufacturer who concealed the side effects of a medical device be punished?

Yes, the case you described may be a matter that can be reported as a violation of the Medical Devices Act.

This is because a person who manufactures or sells a medical device has a duty to accurately indicate and explain the device's performance, efficacy, precautions for use, side effects, and the like.

If a person intentionally omits this or makes a false or exaggerated indication, they become subject to punishment for a violation of the Medical Devices Act.

In particular, if a person sold the device while concealing or failing to state the possibility of side effects despite being aware of it, this amounts to a serious legal violation.

In the event of a violation of the Medical Devices Act, a medical device manufacturer may be subject to administrative dispositions such as cancellation of authorization, along with imprisonment for up to 5 years or a fine not exceeding 50 million won.

If, as in your case, actual harm was caused to the body, such as skin damage, you can also pursue a claim for damages (a civil lawsuit) in parallel.

A report of a violation of the Medical Devices Act can be filed through the website of the Ministry of Food and Drug Safety, the competent regional food and drug administration, Consumer 24, the e-People petition portal, and the like.

It is also advisable to submit supporting materials such as photos of the harm, a hospital medical certificate, and purchase records.

The identity of the reporter is protected, and a report of a medical device adverse case can also be made by a third party, so we recommend that you not hesitate and report in accordance with the formal procedure.

If necessary, we recommend that you also consider consulting with an attorney and pursuing civil and criminal procedures in parallel.