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(영문) 서울남부지방법원 2013.11.19 2013고정2755
의료기기법위반
Text

A defendant shall be punished by a fine of 500,000 won.

If the defendant does not pay the above fine, 50,000 won.

Reasons

Punishment of the crime

Article 2 (Definitions of Medical Devices) (1) The term "medical appliances" in this Act means appliances, machinery, equipment, materials, or other similar products used, alone or in combination, for human beings or animals, which fall under any of the following subparagraphs:

Provided, That drugs and quasi-drugs under the Pharmaceutical Affairs Act and artificial limbs and aids among assistive devices for persons with disabilities under Article 65 of the Act on Welfare of Persons with Disabilities shall be excluded.

1. A product used for the purpose of diagnosing, treating, alleviating, treating, or preventing a disease;

2. A product used for the purpose of diagnosing, treating, alleviating, or correcting an injury or disability;

3. A product used for the purpose of testing, replacing, or transforming a structure or function;

4. No advertisement shall be made with a misleading content that is not used for the control of pregnancy and that there is a performance, efficacy, effect, etc. similar to a medical device;

Nevertheless, on April 12, 2013, the Defendant does not constitute a medical device under the “Regulations on the Classification of Medical Devices and Specific Products” publicly notified by the Medical Devices Act and the Ministry of Food and Drug Safety under the Enforcement Rule of the same Act.

(The defendant and his defense counsel do not assert that the above "D" is a medical device). In advertising Eul, the expression "in body is effective and effective in treating and reducing a specific disease or disease, etc." is a medical device that can be mistaken as a medical device by advertising "mar, gymar, electric power lines, high blood pressure, urology, etc.", and "mars - - insurine, rain, rain, rain, surbine, etc."

I would like to say.

The advertisement was made.

Summary of Evidence

1. Partial statement of the defendant;

1. Application of the Acts and subordinate statutes concerning newspaper advertisement;

1. Relevant Articles of the Act and punishment concerning the facts constituting the crime;

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