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(영문) 의정부지방법원 고양지원 2014.11.27 2014고정1089

의료기기법위반

Text

The defendant shall be punished by a fine of KRW 1,000,000. If the defendant does not pay the above fine, 100.

Reasons

Punishment of the crime

No false or misleading description shall be indicated or written on a container, outer package, packing material, or an accompanying note of a medical device, or any performance, efficacy, or effect that is not permitted or not reported, shall not be indicated or written.

From February 17, 2013 to March 2013, the Defendant: (a) in C’s operation of the Defendant, “medical self-generating machine” in Goyang-gu, U.S., U.S., U.S., even though the license number was granted as “No. 97-4” and “blood cycle improvement,” the effect and effect of the license number different from the license number granted in 5,00 items of the above medical device container 5,00; (b) the effect and effect of the license number different from the license number granted in 5,00 items; and (c) the effect and effect of the license number are “effic and effect: effication: effication of installed parts: effication, blood transfusion, and efficiencation with the body or with severe pain; and (d) effication of effic currents into blood; and (e) efficiencing the effic line in blood, thereby facilitatinging the treatment condition or treatment effect.”

Summary of Evidence

1. Defendant's legal statement;

1. Statement of the D public official;

1. Manufacturing license, each medical appliances manufacturing license; and

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

1. Relevant Articles 52 (1) 1 and 24 (1) 1 and 24 (1) 2 of the Medical Devices Act concerning criminal facts, and selection of fines;

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

1. It is so decided as per Disposition for not less than Article 334(1) of the Criminal Procedure Act.