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(영문) 서울서부지방법원 2016.07.22 2016고정714
의료기기법위반
Text

Defendant shall be punished by a fine of one million won.

If the defendant does not pay the above fine, KRW 100,000.

Reasons

Punishment of the crime

No one shall repair, distribute, lease, award, or use any medical device that has not obtained permission or certification, or has not filed a report, and shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device with respect to which permission or certification has not been obtained, or with respect to which a report has not been filed, or with respect to any other medical device.

1. On September 23, 2014, from around October 27, 2015 to around October 27, 2015, the Defendant sold 7 products, such as “C” in the place of business located in Gangseo-gu Seoul Metropolitan Government, “C”, “D” without obtaining permission or certification, or filing a report, to general consumers via Internet shopping mall, including 300,50,000 won, as indicated in the attached list of crimes.

Accordingly, the Defendant sold a medical device that did not obtain permission or certification, or did not report.

2. From Sep. 23, 2014 to Oct. 27, 2015, the Defendant had the power of cutting down the effect of blood flow in a way that facilitates blood circulation through Internet shopping mall in relation to 8 products, such as medical devices “D,” which did not obtain permission or certification from the above place of business, or file a report, from Oct. 27, 2015.

The term " advertised", etc. was advertised.

Accordingly, the defendant advertised the name manufacturing method, performance, efficacy, and effect of a medical device that is not permitted or certified, or not reported.

Summary of Evidence

1. Statement by the defendant in court;

1. Embling illegal medical device advertising screen;

1. Application of investigation reports ( obtaining details of sales of illegal medical devices from rooftops) Acts and subordinate statutes;

1. Selection of each fine for criminal facts under Articles 51(1), 26(1) (referring to the sale of a medical device without an unauthorized certificate), 52(1)1, and 24(2)5 (referring to the occupation of an advertisement for a medical device without an unauthorized certificate, including the occupation of an advertisement for a medical device without an unauthorized certificate), and 24(2)5 of the Medical Devices Act;

1. The former part of Article 37 of the Criminal Code, Article 38 Section 1 of the Criminal Code, which increases concurrent crimes.

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