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(영문) 서울서부지방법원 2016.05.13 2016고정231

의료기기법위반

Text

Defendant

A A A shall be punished by a fine of two million won, and Defendant B shall be punished by a fine of one million won.

Defendant

A The above fine shall be imposed.

Reasons

Punishment of the crime

Defendant

B is a corporation that operates businesses such as manufacturing and wholesale and retailing of non-medical supplies and equipment, etc., and Defendant A is the representative director of Defendant B.

1. Defendant A

(a) No person who manufactures and sells an unauthorized medical device shall repair, distribute, lease, award, or use a medical device that has obtained permission or certification from, or has failed to file a report with, the Ministry for Food and Drug Safety, or repair, distribute, store, or display a medical device that is manufactured, imported, stored,

Defendant

A manufactured 'D', 'E', 7,00, which is a medical device from around 1995 to around 2009 without obtaining permission for manufacturing medical devices, and sold 30,000 won per unit to unspecified multiple consumers upon the above company's website (F) orders or telephone orders, and awarded the remainder to the organizations requesting the above products.

(b) No advertisement on the performance, etc. of an unauthorized medical device shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device without a license or certification from the food and drug safety wife;

Nevertheless, the Defendant, from April 6, 2012 to November 23, 2015, on B’s website (F), “D” and “E” products, as to “D” and “E products, shall have the effect of reduction of nicotine, air equal effect, air purification,co health, generation, primary radiation, radiation, radiation, radioactive emission, air-conditioning effect 9.8%, 99.8% from the air-conditioning effect, which is related to the prevention of croke, the promotion of the blood cycle of coaches, seizure, air-conditioning effect, air-conditioning treatment and pharmacological effect, and shall improve the respiratory function of the natural body by increasing the respiratory function of the 1,800 p/c/c/O00 from the basic principles, and by increasing the respiratory function of the natural body, more than 1,50% of the pulmonary function of the natural institution.