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(영문) 서울중앙지방법원 2013.05.10 2012고정2814
의료기기법위반
Text

Defendants are not guilty.

Reasons

1. Defendant A is the representative director of Defendant B Co., Ltd. (hereinafter “Defendant Company”), and Defendant Company is a corporation with the purpose of wholesale and retailing medical appliances. A.

Defendant

A No one shall advertise the name, manufacturing method, performance, efficacy, effect, or mechanism of a medical device in connection with an advertisement of a medical device.

Nevertheless, from August 2009 to February 3, 2012, Defendant A made an exaggerated advertisement as if he had the efficacy, such as “contestation and influence”, which is the purpose of use permitted by the Korea Food and Drug Administration (the current Ministry of Food and Drug Safety), different from “confluence and influence of pain”, as the “confluence removal of skin regeneration, accelerator removal, niver axis, and nivers management,” which is the object of use permitted by the Korea Food and Drug Administration (the current Ministry of Food and Drug Safety).

B. Defendant Company made an exaggerated advertisement on the efficacy and effect of medical devices as above by Defendant A, the representative director of Defendant Company, in relation to Defendant Company’s business at the above date and place.

2. Determination

A. In order to find the Defendants guilty of the facts charged in the instant case, the Defendants’ advertisement of the instant medical device as if the medical device had efficacy, such as “fluoral recycling, cellul removal, luculing, and luculatory management,” based on the evidence submitted by the Prosecutor, should be proven to constitute an exaggerated advertisement.

B. According to the evidence submitted by the Prosecutor and the F’s statement in this Court, the fact that the purpose of use permitted for the instant medical device is the reduction of the pain and the reduction of the subsidiary type can be acknowledged.

C. However, according to the evidence submitted by the Defendants and attached to the trial records of this case, the high-time destruction machine, such as the medical device of this case, is actually managed before and after the skin regeneration, accelerator removal, crymanal storage, and burine.

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