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(영문) 서울서부지방법원 2018.05.16 2017고정1551
의료기기법위반
Text

Defendant shall be punished by a fine of KRW 500,000.

Where the defendant fails to pay the above fine, one hundred thousand won shall be one day.

Reasons

Punishment of the crime

The defendant is a person who manufactures and exports electronic devices from C to D in both weeks, and sells a medical device.

No one shall advertise the name of a medical device, the method of manufacturing, the performance, efficacy, and effect of a medical device without permission or certification, or inconsistent with any description notified.

Nevertheless, the Defendant intended to sell reusable tents, which are medical devices, in Yangju City, obtained an import declaration from the head of the Seoul Local Food and Drug Safety Office (Seoul received E, product name: 3RS, and 52 items) on September 5, 2013, and imported from China on the website (F) and did not advertise with 7RL (Round L), 9R, 11R, and 14R as a medical device on the Internet homepage (F), and advertised with any name different from those reported with 7PRL (Poin L), 9PRL, 11PRL, 14PL, and 50 million won from December 12, 2015 to June 30, 2016.

Summary of Evidence

1. Statement by the defendant in court;

1. A certificate;

1. A medical device import declaration certificate;

1. Application of Acts and subordinate statutes on Internet homepages;

1. Relevant Article 52 of the Medical Devices Act, Articles 52 (1) 1 and 24 (2) 5 of the same Act concerning criminal facts, the selection of fines, and the selection of fines;

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

1. Article 334 (1) of the Criminal Procedure Act concerning the order of provisional payment;

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