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(영문) 인천지방법원 2019.05.24 2018노3819
의료기기법위반
Text

The defendant's appeal is dismissed.

Reasons

1. Summary of grounds for appeal;

A. The Defendant does not have any fact that the “C” (hereinafter “the Esck of this case”) as indicated in the judgment of the court below was advertising as a medical device.

In addition, the Defendant advertised that the instant Make had the efficacy or effect similar to the actual medical device, and thus, it cannot be said that there was an intentional act in violation of the Medical Devices Act.

B. The applicable provisions of this case against the defendant in misapprehension of the legal principle are unconstitutional provisions that infringe on freedom of expression.

C. The lower court’s sentence of unreasonable sentencing (fine 500,000) is too unreasonable.

2. Determination

A. Comprehensively taking account of the following facts and circumstances acknowledged by the evidence duly adopted and examined by the lower court regarding the assertion of mistake of facts, the Defendant advertised likely to mislead the Defendant to have the performance, efficacy, and effect similar to the medical device, and the Defendant sufficiently recognized that there was an intentional act on the part of the Defendant.

1) The Defendant advertised the following contents: “The instant Mack is to prevent coke and scarcity, etc. to improve pulmonary and pulmonary health.” This is effective to treat, reduce, and prevent the instant Mack disease. As such, Article 2(1)1 of the Medical Devices Act provides products used for the purpose of diagnosing, treating, alleviating, alleviating, treating, or preventing diseases as medical devices. As such, even if the Defendant did not explicitly use the expression “medical device” in the advertisement, it constitutes a case where the Defendant advertised an industrial product as having the function or efficacy similar to that of the medical device. 2) Article 26(7) of the Medical Devices Act prohibits advertisements that are not medical devices, and thus, it is prohibited, even if the instant Mack actually has the effect or efficacy of treating, alleviating, or preventing the instant disease.

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