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(영문) 수원지방법원 안산지원 2012.06.28 2012고정729

의료기기법위반

Text

Defendant shall be punished by a fine of KRW 3,000,000.

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

Reasons

Punishment of the crime

The defendant is a person who operates a medical device manufacturer with the trade name in Ansan-si, Ansan-si C.

Any person who intends to distribute a medical device shall submit an application to the head of the Korea Food and Drug Administration reviewing agency for the quality control of medical devices registered with the Korea Food and Drug Administration and obtain recognition of conformity with standards

Nevertheless, the Defendant did not obtain recognition of conformity with the standards for manufacturing and quality control of medical devices, and sold approximately 1,000 Gabs to D, a company selling medical device from December 18, 2009 to January 13, 2012.

Summary of Evidence

1. Partial statement of the defendant;

1. Police suspect interrogation protocol of the accused;

1. A public official statement of E;

1. F's certificate;

1. Application of statutes on a copy of contract;

1. Relevant Article 52 (1) 1 and Article 13 (1) of the Medical Devices Act concerning criminal facts, the selection of punishment, and the selection of fines;

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;