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(영문) 인천지방법원 부천지원 2014.09.25 2014고정861
의료기기법위반
Text

Defendant shall be punished by a fine of KRW 2,000,000.

If the defendant does not pay the above fine, the amount of KRW 100,000 shall be paid.

Reasons

Punishment of the crime

A person who intends to advertise a medical device shall undergo prior deliberation by the Minister of Food and Drug Safety in accordance with the standards, methods, and procedures for deliberation prescribed by the Minister of Food and Drug Safety, and shall not place an advertisement with any content different from those deliberated upon, and no person shall place an advertisement with respect to the name, manufacturing method, performance, efficacy, or effect of a medical device with no permission for importation

1. On February 14, 2014, the Defendant posted an advertisement of the personal hot fever (a model name: F) as a medical device by accessing the Internet site (E) at the main office of the business entity importing and selling medical devices operated by the Defendant in Bupyeong-si, Seocheon-si, Nowon-gu. Around that time, the Defendant advertised contents different from those deliberated by the Minister of Food and Drug Safety by widely deleting the contents of the advertisement deliberated by the Minister of Food and Drug Safety.

2. 피고인은 2014. 2. 14.경 위 D(주) 사무실에서, 인터넷 사이트(G)에 접속하여 의료기기인 개인용 온열기(모델명 : F)에 대한 광고를 게재함에 있어, 식품의약품안전처장의 사전 광고심의를 받지 않고 ‘촉촉하고 편안한 눈을 위한 개인용 온열기’, ‘봄철 눈물이 많이 나서 고생하시는 분’, ‘눈이 충혈되고 건조해서 고생하시는 분’, ‘컴퓨터를 오래 사용하시는 직장인을 위한!!’, ‘적당한 열과 수분찜질로 눈의 건조함을 완화시켜줍니다’, ‘눈 주변의 피부와 관자놀이를 마사지 해주어 눈의 피로를 풀어줍니다’, ‘F은 임상자료를 거친 부작용 적은 개인용 온열기 진동기입니다.’라는 내용으로 식품의약품안전처장의 심의를 받지 않은 내용의 광고를 하였다.

3. On March 13, 2014, the Defendant was subject to the disposition of revoking marketing approval of medical devices with respect to the medical vibration (a model name: I) at the Incheon Local Food and Drug Safety Agency (hereinafter “Korea Food and Drug Safety Agency”), but on February 14, 2014.

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