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(영문) 인천지방법원 부천지원 2014.03.21 2014고정62
의료기기법위반
Text

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

If the defendant does not pay the above fine, 50,000 won.

Reasons

Punishment of the crime

The Defendant is a person who carries on the manufacturing business of medical appliances with the trade name called “Dmerdik” from 704 of the Kucheon-si Seoul Building Co., Ltd.

1. No person shall distribute a medical device without a license to manufacture a medical device, or manufacture a medical device with intent to distribute, lease, provide, or use it;

Nevertheless, from October 21, 2009 to November 13, 2013, the Defendant manufactured and sold products for strengthening the sexual function called ‘E', which is a medical device that did not obtain permission from the Minister for Food and Drug Safety from the above Dmerk to the above Dmerkn from November 21, 2013.

2. No one shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device without a manufacturing license;

Nevertheless, around August 27, 2013, the Defendant advertised the name, performance, efficacy, etc. of a medical device for which permission was not granted by inserting an advertisement containing the words such as ‘E' on the 15th page of the Sports Shipbuilding newspaper, with the effect of the maximum length extension.'

Summary of Evidence

1. Court statement of the defendant (the second court date);

1. Application of the Acts and subordinate statutes on the written accusation;

1. Relevant provisions of the Medical Devices Act concerning criminal facts, Articles 51 (1) and 26 (1) of the Act on the Selection of Punishment (which means the manufacture and sale of unauthorized Medical Devices), Articles 52 (1) 1 and 24 (2) 5 (which means advertisements without permission) of the Medical Devices Act, and the selection of fines;

1. Of concurrent crimes, the former part of Article 37, Articles 38 (1) 2 and 50 of the Criminal Act;

1. Articles 70 and 69 (2) of the Criminal Act for the detention of a workhouse;

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

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