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(영문) 서울중앙지방법원 2014.11.13 2014고정2123
의료기기법위반
Text

Defendants shall be punished by a fine of KRW 500,000.

Defendant

If A does not pay the above fine, 100,000.

Reasons

Punishment of the crime

Defendant

A is the representative director of corporation B, and Defendant B is a corporation managed by Defendant A.

1. The Defendant, the Defendant, or the Defendant, shall not put an indication on an outer package of any appliance other than a medical device, or an advertisement with any content 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 on the outer package, packing material, or an accompanying note. Notwithstanding that the content indicated or advertised is prohibited from selling, leasing, storing, or displaying for the purpose of leasing, selling, or leasing, any appliance marked or advertised, the Defendant, on September 16, 2012, advertised on the outer package, packing material, or an accompanying note using the phrase that is likely to mislead any person into being aware that the product, other than a medical device, has a performance, efficacy, or effect similar to that of a medical device (the prevention of damp-proof, sperm, etc., and undermining the physiological ability).

2. Defendant B, a representative of the Defendant, committed an act identical to that described in paragraph 1, and neglected to exercise due care and supervision to prevent such an act.

Summary of Evidence

1. Legal statement of witness F;

1. A written statement;

1. Application of the Acts and subordinate statutes on the written accusation;

1. Article relevant to the facts constituting an offense and the selection of punishment;

(a) Defendant A: Article 52 (1) 1 and Article 26 (7) of the Medical Devices Act (Selection of Fines);

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

1. Defendant A at a workhouse: Articles 70 (1) and 69 (2) of the Criminal Act;

1. Defendants of the provisional payment order: Article 334(1) of the Criminal Procedure Act

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