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(영문) 서울서부지방법원 2019.01.24 2018노742
의료기기법위반
Text

The judgment of the court below is reversed.

Defendants are not guilty. The summary of the judgment against the Defendants is publicly announced.

Reasons

1. The summary of the grounds for appeal did not indicate a medical device on the part other than a medical device.

2. Defendant A is the actual operator of Defendant B Co., Ltd.

Defendant

A No one shall make any indication on an outer package, emblem, or package inserts of any appliance other than a medical device, or make any advertisement with such misleading contents as likely to mislead anyone to believe that the appliance has a performance, efficacy, or effect similar to that of a medical device, or distribute or lease, or store or display, with intent to distribute or lease, any appliance marked or advertised with such misleading contents.

Nevertheless, on June 20, 2014 and October 22, 2014, the Defendant supplied an industrial product entirely (hereinafter “instant intrusion”) to the C Care Center on two occasions, and falsely indicated that “the name of goods: passive medical intrusion; the product is a medical device; the product is a medical device; the product report number: D; the purpose of use: a manual intrusion used for patient treatment at a medical institution;” and sold a total of KRW 100 and the market price of KRW 75 million as indicated in the attached list of crimes.

B. Defendant B, in relation to the above date, time, and place, committed a violation as set forth in the preceding paragraph by Defendant A, an employee.

3. According to the records, the defendants completed the import declaration of medical devices against the non-Party E and two, and imported and sold the same, and there is a sign of "hive-type medical intrusion" in the passive beds. The defendants sold the same with the permission of the aforementioned passive beds by adding the electric operation device, such as the mother to the above passive beds. However, the defendants concluded a supply contract with the C medical care center, and delivered the same with the above imported passive beds by adding the electric operation device to the above imported passive beds. Thus, the defendants should deliver the same beds between C medical care center and C medical care center.

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