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(영문) 서울중앙지방법원 2017.09.18 2017고정2585
의료기기법위반
Text

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

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

Reasons

Punishment of the crime

The defendant is the actual operator of C, a medical device manufacturing and selling company, which is located in the main body of B in Seoul, the Gu.

1. No one shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device without a permit or certification in connection with an advertisement or with any other device different from a thing reported;

Nevertheless, from October 2016 to November 101, 2016, the Defendant placed an advertisement on the name of medical device, manufacturing method, efficacy, and effect of medical device by inserting such contents as “D” for strengthening the sexual function of “D”, which is a medical device that did not obtain a permit (a permit or report) in accordance with the Medical Devices Act, by releasing from an original external line, and by expanding the blood flow and promoting strong blood cycle.”

2. No one shall repair, distribute, lease, award, or use any medical device that has not obtained permission or certification, or has failed to file a report, and shall manufacture, import, repair, store, or display any medical device for the purpose of distribution, lease, or use;

Nevertheless, from October 4, 2016 to November 30, 2016, the Defendant sold KRW 25,200,000 at the 126 market price by manufacturing and sending “D”, which is a medical device that was not permitted (such as a certificate or report) in accordance with the Medical Devices Act, upon receipt of an order for purchase telephone from a large number of unspecified persons.

Summary of Evidence

1. Statement by the defendant in court;

1. Entrustment of investigation into violations of the Medical Devices Act;

1. Application of D sales details legislation

1. Relevant Article of the Act concerning criminal facts and the medical appliances selected for punishment;

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