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(영문) 서울중앙지방법원 2018.07.17 2018고정764

의료기기법위반

Text

Defendant shall be punished by a fine of KRW 2,000,000.

When the defendant does not pay the above fine, 100,000 won.

Reasons

Punishment of the crime

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

From December 20, 2016 to October 19, 2017, the Defendant operates the Seocho-gu Seoul Metropolitan Government B Building C, and D companies, and set up a hearing aid (design name: E-I48) type hearing aids (E model name) for sale of medical appliances, “a hearing aid that has the effect of improving the fundamental hearing ability of human by stimulatinging the scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic s

“In order to compensate for a hearing disorder, the hearing aid described as “,” was placed in an exaggerated advertisement as if it were a medical device for improving hearing ability, even though the hearing aid was an apparatus which delivered by means of air with a large amount of noise to compensate for a hearing disorder.

Summary of Evidence

1. Partial statement of the defendant;

1. A written accusation of a medical device;

1. A public official's statement in charge of accusation;

1. A certificate;

1. Advertisement leaflets for medical devices, details of information on medical device business entities, application of new electronic civil petition counseling books for civil petitions, and statutes to which data submitted are to be submitted;

1. Relevant provisions of the Medical Devices Act concerning facts constituting a crime and Articles 52 (1) 1 and 24 (2) 1 of the Medical Devices Act (excluding punishment) of the same Act concerning the choice of punishment;

2. Article 70 (1) and Article 69 (2) of the Criminal Act to attract a workhouse.

3. Judgment on the assertion of the defendant and his/her defense counsel under Article 334(1) of the Criminal Procedure Act (the grounds for conviction) of the Criminal Procedure Act

1. There was no act of advertising, such as distributing to many and unspecified persons the gist of the assertion, and “E technology” used in hearing aids as indicated in the judgment does not constitute an exaggerated advertisement, since it was verified of stability and effectiveness through clinical trials, etc.

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