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(영문) 대전지방법원 2017.10.31 2017고정115

의료기기법위반

Text

The defendant shall be innocent.

Reasons

1. The Defendant is a person who operates a medical device sales business entity (State) D in Daejeon-gu, Daejeon-gu.

No person shall make a false or exaggerated advertisement about the name, manufacturing method, performance, efficacy, effect, or mechanism of a medical device.

Nevertheless, from May 25, 2016 to May 26, 2016, the Defendant sold “F”, which is a medical device reported to manufacture products through “E” at the Internet Open Market. Although the medical device did not prove safety and effectiveness in relation to a specific disease, the Defendant made a false or exaggerated advertisement on the efficacy and effect of the medical device by stating the phrase “f” (i.e., “unencing force, cococo-prevention devices, cokes, and cocokes and cocococokesive force,” and (ii) stating that “the efficacy and effectiveness of the medical device is difficult to prevent,” and (iii) stating the phrase “the part that grow up by force in the surface of the body of the body of the Republic of Korea and the body of the Republic of Korea and the body of the Republic of Korea and the body of the Republic of Korea and the body of Korea.”

2. Determination

A. According to each evidence duly admitted and examined, the following facts can be acknowledged.

① The Defendant, while operating a medical device dealer called “the instant company” (hereinafter referred to as the “instant company”), sold the medical aid equipment, F, which, by expanding the rain, prevents copic power, on the Internet (hereinafter “the instant medical device”).

② The instant company is retail store that received and sold the instant medical device from G, and the manufacture was made by H and salesperson, and the Plaintiff and the Plaintiff were G.

(3) Generally, a medical device may be advertised only when it has received prior approval from an institution subject to prior deliberation. Preliminary deliberation on medical device advertising shall be conducted upon entrustment by the Korea Medical Device Industry Association, an incorporated association (hereinafter referred to as the “Association”) of deliberation by the food and drug wife.

④ An advertisement on the instant medical device was a lawful advertisement approved by the Association as of December 26, 2014. The food and drug wife was the stability and effectiveness of the instant medical device on May 2, 2016.