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(영문) 서울남부지방법원 2020.10.22 2019노2376

의료기기법위반

Text

The judgment of the court below is reversed.

Defendants are not guilty.

Reasons

1. The summary of the facts charged in this case is a person who is in charge of the business division in the company B located in Guro-gu Seoul Metropolitan Government Co., Ltd., and Defendant B is a corporation established for the purpose of medical device distribution business.

Defendant

A In advertising a medical device, no one shall place an advertisement using an article that is likely to mislead any physician, etc. to believe that the medical device is performing, efficacy, or effect of a medical device, or that such a medical device is being used.

Nevertheless, around August 2018, the Defendant requested F to advertise “E”, which is a medical device, at the office B office located in Guro-gu Seoul Metropolitan Government C building D, and entered the list of doctors using the relevant product, and advertised that the Defendant expressed the above medical device as if the Defendant recommended or used the medical device.

B. The Defendant Company B is the Defendant’s business director A in relation to the Defendant’s business

As described in the subsection, the act of violation was committed.

2. The summary of the grounds for appeal (the factual errors and misapprehension of the legal principles) ① The instant advertisement does not constitute “advertisement using news articles” under Article 24(2)2 of the Medical Devices Act, and ② “F” is a medium that does not undergo prior deliberation on medical device advertising, and the instant advertisement inserted in the said medium is not subject to Article 24 of the Medical Devices Act. ③ The instant advertisement is not subject to Article 24 of the Medical Devices Act, and it does not constitute a case where the other party to the advertisement is a dentist, and it is likely that the other party to the advertisement may cause misjudgments

3. Article 24(2)2 of the Medical Devices Act provides that “A doctor, dentist, doctor of oriental medicine, veterinarian, or any other person shall guarantee, recommend, approve, guide, or recognize the performance, efficacy, and effect of a medical device with respect to any type of advertisement prohibited in relation to the advertisement of a medical device, or such a medical device.