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(영문) 광주지방법원 2014.04.09 2013노2589
의료기기법위반
Text

The judgment of the court below is reversed.

The sentence of each sentence shall be suspended against the Defendants.

As to the Defendants, this case is against the Defendants.

Reasons

1. Summary of the charge of violation of the Medical Devices Act due to the sale of unauthorized medical appliances, and the judgment of the court below

A. The summary of the facts charged is prohibited from repairing, selling, leasing, using, or using any medical device without obtaining permission from the competent authority or filing a report, Defendant A manufactured 982 dental appliances fixed companies (HA surface processing method; hereinafter “instant fixed companies”) for the purpose of domestic sales in the KAB, and sold it to the KAD Co., Ltd., and Defendant B, the representative director of the KAB, sold the medical device without permission in relation to his/her duties.

B. The lower court found Defendant A guilty of the facts charged on the ground that Defendant A intentionally sold the fixed company in this case to the Bank of Korea, by compiling the evidence as indicated in its holding.

2. Summary of the grounds for appeal and the judgment of this court

A. The summary of the grounds for appeal (1) misunderstanding of facts argues that around April 2012, the Defendants: (a) sold dental marries (use of the RBM surface processing method; hereinafter “MM fixed companies”) permitted to sell dental marries in Korea to the KBA Co., Ltd.; and (b) sold dental marries with 982 fixed companies not permitted for domestic sales in the number of employees, and there was no intention to sell them.

(2) The Defendants asserts that the lower court’s respective fines of KRW 2,00,000,00, which the Defendants sentenced to the Defendants, are too unreasonable.

B. According to the evidence duly adopted and examined by the court below and the testimony made by the witness I in this court, the defendant LAB entered into a contract for supply of goods with the effect that on January 9, 2012, the plaintiff LAB shall set at 15,000 won per opening to the LAB and the LAB-fixed companies, which shall sell AlA-M fixed companies to the LAB-affiliated. The defendant B shall be from January 3, 2012 to October 2012.

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