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(영문) 인천지방법원 2017.10.13 2017고정1983
의료기기법위반
Text

Defendant shall be punished by a fine of KRW 5,000,000.

When the defendant does not pay the above fine, 100,000 won.

Reasons

Punishment of the crime

The Defendant is a personal communications seller residing in Seo-gu Incheon, Seo-gu and 205.

(a) No one shall repair, distribute, lease, award, or use a medical device that has not obtained a license or has failed to file a report in accordance with Article 6(2) or 15(2), or manufacture, import, repair, store, or display a medical device for the purpose of sale, lease, or use;

Nevertheless, on August 2016, the Defendant imported 20 parts of the total number of the products directly purchased in Japan through the name of the branch in the name of the male-use Cor Sea (the name of the products: the name of the Kaoto/Sa cam) that is a medical device that was not permitted on or around August 2016.

Thus, the Defendant provided three free of charge to the branch of the land around December 2016, and from January 14, 2017 to March 9, 2017, the Defendant sold 50,000 won in total to the unspecified buyers who want to purchase the product during the advertisement period by inserting 48 times in total the advertising materials with product information (e.g., the name of the product: the name of the Red Sea (S. cartooto/S.) of the Pream (S.) for the purpose of selling the product under the "S.", which is the Internet site (NAC) in the above Internet site from January 14, 2017 to March 1, 2017.

(b) No one shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device that does not obtain a license or certification, or that does not conform to a notification, in relation to an advertisement of a medical device pursuant to Article 6(2) or 15(2).

Nevertheless, on August 2016, the Defendant imported 20 parts of the total number of the products directly purchased in Japan through the name of the branch in the name of the male-use Cor Sea (the name of the products: the name of the Kaoto/Sa cam) that is a medical device that was not permitted on or around August 2016.

Therefore, the Defendant provided three free of charge to the branch of the land around December 2016. From January 14, 2017 to March 9, 2017, the Defendant shared the Internet site (NAV car page) at the same location.

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