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(영문) 서울남부지방법원 2018.04.12 2017고단6518

의료기기법위반

Text

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

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

Reasons

Punishment of the crime

The Defendant is a person who operates a trade name “C” under the underground of the building located in Yeongdeungpo-gu Seoul Metropolitan Government.

A person who intends to engage in the business of selling medical technicians shall report the sales business to the head of the Gu where the place of business is located, as prescribed by Ordinance of the Ministry of Health and Welfare.

Nevertheless, the Defendant operated the above C from September 2012 to September 5, 2017, and sold a medical device such as an injection amounting to KRW 6 billion without reporting the distribution of the medical device to the head of the competent Gu.

Summary of Evidence

1. Statement by the defendant in court;

1. A written accusation and a public official statement;

1. Application of Acts and subordinate statutes to a report on investigation (report appended to suspect data);

1. Relevant provisions of the Medical Devices Act concerning criminal facts, Article 52(1)1 and (2) of the same Act concerning selective punishment, and Articles 17(1) and 17(1) of the same Act, the selection of fines;

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

1. The reason for sentencing under Article 334(1) of the Criminal Procedure Act does not appear to have complied with the reporting procedure with the intent of the Defendant to engage in illegal business, such as omitting a tax return. On the other hand, the reporting procedure is too complicated or heavy expenses are not required. On the other hand, the medical device dealt with by the Defendant is not deemed to have a significant benefit by omitting the reporting procedure by the Defendant as it contributes to a medical instrument that can be sold only if it is declared, and thus, the Defendant’s entry and completion of the report on the medical device distribution business on the following day, the Defendant’s entry and completion of the report, the Defendant