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(영문) 수원지방법원 성남지원 2014.08.26 2014고정824

의료기기법위반

Text

1. The defendant shall be punished by a fine not exceeding 1.5 million won;

2. If the defendant does not pay the above fine, 10,000 won.

Reasons

Punishment of the crime

No one shall make any indication on an outer package, packing material, or an accompanying document of any appliance other than a medical device, that is likely to mislead any person to believe that the appliance has a performance, efficacy, or effect similar to that of a medical device, or make any advertisement with such misleading contents, or distribute or lease, store, or display, with intent to distribute or lease, an appliance marked or advertised with such misleading contents.

피고인은 2013. 7. 초순경 ~ 2013. 7.중순경까지 광주시 B, 2층에 있는 피고인이 운영하는 ‘C’ 사무실에서 ‘C’ 온라인 쇼핑몰(D)과 제휴업체 ‘(주)디씨골프’ 등 12개 업체 온라인 쇼핑몰에 의료기기가 아닌 ‘원적외선 건강팔찌’와 ‘건강팔찌 신기루’에 대한 광고 글을 게시하면서 “원적외선 겅강팔찌, 방사에너지 방출로 운동시 혈액순환 신진대사 도움.”, “Power Ring 건강팔찌 게르마늄, 자수정, 투어머린 혼합, 운동시 혈액순환, 신진대사 도움.”문구를 사용하였다.

As a result, the Defendant sold “originally Outboard Ship Health Coas” and “Health Coas,” rather than a medical device, and advertised likely to mislead the Defendant into being aware of the performance, efficacy, effect, etc. similar to a medical device.

Summary of Evidence

1. Defendant's legal statement;

2. E statements;

3. F's certificate;

4. Application of Acts and subordinate statutes to a photograph by capturing a DNA golf online shopping mall;

1. Relevant Article 52 (1) 1 and 26 (7) of the Medical Devices Act, Articles 52 (1) and (1) of the same Act concerning criminal facts, the selection of fines;

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