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(영문) 전주지방법원 2016.06.10 2016고단268
의료기기법위반
Text

Defendant

A shall be punished by imprisonment with prison labor for six months and by imprisonment for four months.

, however, from the date this judgment becomes final and conclusive.

Reasons

Punishment of the crime

No one shall repair, distribute, lease, award, or use any medical device that does not obtain marketing approval or file a product notification, and no one shall manufacture, import, repair, store, or display for the purpose of sale, lease, grant, or use. However, the Defendants conspired to gain profits by printing numbers and pictures as a special form of optical material on the back side of the lap card, etc., such as lap cards.

On October 20, 2013, the Defendants: (a) purchased Contact E 101 in the name of the Defendant B, who was in the name of the Jeonjin-gu, Jeonjin-gu; (b) purchased 300,000 won per set from G, a manufacturer and dealer of the “Ba Card” and stored Contact E 300,000 won for the purpose of sale; (c) continuously thereafter, purchased 400,000 won per set and sold 30,000 won for fraud by combining the “Ba Card” and “Mae” into one set of 30,000 won per sheet to use for fraud.

As above, from September 5, 201 to April 11, 2014, the Defendants stored a medical device that did not obtain marketing approval from around 30 times, or that did not file marketing notification, for sales purposes. Around that time, the Defendants sold an amount equivalent to 30 million won among the above medical devices.

Summary of Evidence

1. Defendants’ respective legal statements

1. A protocol concerning examination of the suspect of each public prosecutor with regard to G or H;

1. Application of the Acts and subordinate statutes for investigation reporting;

1. Relevant legal provisions and the Defendants’ choice of punishment regarding criminal facts: the former Medical Devices Act (amended by Act No. 13116, Jan. 28, 2015).

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