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(영문) 서울북부지방법원 2014.11.28 2014노895

의료기기법위반

Text

The judgment of the court below is reversed.

The defendant shall be innocent.

Reasons

1. Summary of grounds for appeal;

A. In light of the legal principles, the advertising phrase of this case, which indicated “nickness to assist in an oral movement,” does not constitute a medical device that is likely to mislead the public official in charge of the Nowon Public Health Center as well as the fact that it is confirmed that there is no possibility to mislead the public official in charge of the Nowon Public Health Center as a medical device. As such, there is a justifiable reason for the Defendant to believe

B. The sentence (one million won of fine) imposed by the lower court is too unreasonable.

2. Determination

A. The summary of the facts charged in the instant case and the judgment of the court below 1) the Defendant is a person who runs the Internet sales business in the name of “C.” No one shall make any indication or advertisement with the content that is likely to mislead any person to believe any performance, efficacy, effect, etc. similar to a medical device on the outer package, packing, or appended note of an article, other than a medical device, or shall sell, lease, store, or display any article indicated or advertised. Nevertheless, around February 20, 2014, the Defendant was guilty of the facts charged in the instant case by taking into account the evidence in the judgment of the court below.

B. Article 2 of the Medical Devices Act provides that “medical appliances” shall be diagnosed, treated, mitigated, treated, or prevented from diseases, or diagnosed, treated, mitigated, or corrected, or the structure or function of which shall be examined, replaced, or corrected, or the structure or function of which shall be examined, replaced, or performed solely or in combination with human beings or animals.