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(영문) 의정부지방법원 2017.08.17 2016고정2386

의료기기법위반

Text

The defendant shall be innocent.

Reasons

1. On February 11, 2015, the Defendant is a person who is engaged in the business of selling medical devices in the online open market in the name of “C” after reporting on the business of selling medical devices to the viewing of Namyang-ju, and then is engaged in the business of selling medical devices.

No one shall place an advertisement with any content different from that deliberated upon in connection with an advertisement of a medical device.

Nevertheless, from April 2016 to August 2, 2016, the Defendant placed an advertisement using the expression “D” differently from the content of prior deliberation while selling automatic blood pressure (a model name: BP3BM1-3) from the Internet shopping mall, such as “heat,” etc.

2. Determination

A. The gist of the Defendant’s assertion is that the Defendant advertised the instant medical device as it was deliberated upon by the Defendant and his defense counsel. However, the intent of the Defendant merely presented objective evidence to the “D,” along with the description “D,” and it cannot be deemed that such additional part does not contravene the intent of the prior medical device advertising deliberation system, and thus, it cannot be deemed that the Defendant engaged in an advertisement with any content different from the content deliberated upon.

(b) as shown in the attached Form of the relevant regulations.

(c)

Article 24(2)6 of the Medical Devices Act provides for the purpose of Article 24(2)6 of the Medical Devices Act. Article 24(2) of the Medical Devices Act prohibits any false or exaggerated advertisement that may cause consumers to misunderstand the performance, effects, or principles of the medical devices (Article 1 through 3), and prohibits any advertisement (Article 24(2)6 of the Medical Devices Act) with any content that is not subject to deliberation under Article 25(1) or different from the content that is subject to deliberation (Article 25(1).

Article 45 (1) and attached Table 7 of the Enforcement Rule of the same Act based on Article 24 (3) of the same Act also set the scope of various prohibited advertisements, and the efficacy, effects, etc. of the relevant medical device.