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(영문) 전주지방법원 2016.05.31 2016고정214

의료기기법위반

Text

Defendant

A shall be punished by fine for negligence of KRW 2,000,000, and by fine of KRW 1,000,000.

Defendant

A above.

Reasons

Criminal facts

1. No person shall put a mark on an outer package, packing, or appended document of any appliance other than a medical device, that is likely to mislead any person to believe that the appliance has a performance, efficacy, or effect similar to that of a medical device, or make an advertisement with such misleading content;

From Jun. 10, 2015 to Nov. 16, 2015, the Defendant sold “G”, a product of the said company, through the company’s website (F) at the B office located in the complete city E-gu Seoul Metropolitan City from Jun. 10, 2015 to Nov. 16, 2015, and explained that if the Defendant’s equipment could not be hidden into the co, it could cause a variety of diseases, such as a decline in immunity function, alurgic disease, chronic skin, etc., and explained that “G” may stimulate bovine’s blood, increase the heat circulation and copulmonial volume of the co by expanding the brea and expanding the brea, etc., which would cause a increase of the brea capacity of the cco, thereby misleading the brea’s respiratory function and preventing the breameric disease, chronic skin disease, etc.

2. Defendant B Company is a corporation established for the purpose of manufacturing and selling medical devices.

Defendant

A, the representative of the company, made an advertisement that could be misunderstood as above with respect to the business of the defendant company at the above date and place.

Summary of Evidence

1. A protocol concerning the examination of suspect of the defendant A;

1. Application of a copy of confirmation, copy of advertising-related data, and business registration certificate;

1. Relevant legal provisions concerning criminal facts;

(a) Defendant A: Article 52(1)1 and Article 26(7) of the Medical Devices Act, all of which include Defendant A (excluding punishment)

(b) Defendant B: The main sentence of Article 55 of the Medical Devices Act, Articles 52 (1) 1 and 26 (7) of the Medical Devices Act;

1. Defendant A to be detained in a workhouse: Articles 70 (1) and 69 (2) of the Criminal Act;

1. Determination on the Defendant’s assertion under Article 334(1) of the Criminal Procedure Act, respectively, of the provisional payment order

1. The summary of the claim.