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(영문) 수원지방법원 2016.11.30 2016고정2634

의료기기법위반

Text

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

If the defendant does not pay the above fine, KRW 100,000.

Reasons

Punishment of the crime

The defendant is the representative of the wholesale and retail chain C of the industrial products, which are in Yongsan-si B and 103 Dong 508.

1. No person shall repair, distribute, lease, provide, or use any medical device without obtaining permission or certification, or filing a report under Article 6 (2) or 15 (2) of the Medical Devices Act, or manufacture, import, lease, provide, store, or display any medical device for the purposes of sale, lease, granting, or use;

Nevertheless, around September 2015 and around May 28, 2016, the Defendant imported approximately 2,125 finished products from ECOBNDS located in the United Kingdom, and sold a total of KRW 430 (14,500 / 14,500 / 14,500) to IMN trading located in Gangnam-gu Seoul Metropolitan Government from May 2016 to June 9, 2016.

2. No one shall place an advertisement about the name, manufacturing method, performance, efficacy, or effect of a medical device without obtaining permission or certification, or inconsistent with matters reported under Article 6 (2) or 15 (2) of the Medical Devices Act, in connection with an advertisement of a medical device;

Nevertheless, around the beginning of May 2016, the Defendant directly produced and provided advertising materials (use method, efficacy effect, product size, etc.) on products that include expressions such as mitigation of learning that could lead to misunderstanding as a medical device while selling a total of 430 personal-use electric theater (product name: Zit Capital) that was not permitted as a medical device in Gangnam-gu Seoul Metropolitan Government.

Summary of Evidence

1. Defendant's legal statement;

1. A criminal investigation report (referring to a report on examination of whether a medical device is applicable and a report on confirmation of official correspondence) and a copy of official document of the Ministry of Food and Drug Safety;

1. A investigation report (Reporting on confirmation of regulations on items of medical devices and the ratings by item);

1. An investigation report (C's report on confirmation of an import declaration) and an import declaration;