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(영문) 서울중앙지방법원 2018.11.30 2018노2276
의료기기법위반
Text

The judgment below

Of the above, the part against Defendant C is reversed.

Defendant

A corporation shall be punished by a fine of 30,000 won.

Reasons

1. Progress of the case and scope of the trial

A. According to the progress records of the case, the following facts can be acknowledged.

1) As to the violation of the Medical Devices Act due to the advertisement of the imported medical appliances without permission or not reported by Defendant B, the lower court convicted Defendant Company and the Defendant Company of the violation of the Medical Devices Act due to the use of the imported medical appliances without permission or not reported by Defendant A and B, respectively.

2) As to this, the Defendant Company and the joint Defendants appealed on the grounds of mistake of facts, misunderstanding of legal principles, and illegality in sentencing.

3) The appellate court prior to remand rejected the allegation of misunderstanding the above facts and misapprehension of the legal principles and the above A’s unfair argument in sentencing. On the grounds that the Defendant Company and the above B omitted the application of aggravated laws and regulations regarding concurrent crimes, the part concerning the Defendant Company and the above B were reversed ex officio, and sentenced to a fine by recognizing the whole guilty part of the judgment below, and dismissed the appeal by the above A.

4) Accordingly, Defendant Company and the above joint Defendants appealed on the legal principles regarding the concept of medical appliances under the Medical Devices Act, intentional violation of the Medical Devices Act, and the concept of advertisement, and the Defendant Company’s appeal on the grounds of misapprehension of the legal principles as to the scope of application of both punishment provisions.

5) The Supreme Court rejected the allegation of misunderstanding the legal principles as to the concept of medical devices under the Medical Devices Act, the intentional violation of the Medical Devices Act, and the concept of advertisement, and accepted the allegation of misunderstanding the legal principles as to the scope of application of both punishment provisions by the Defendant Company. As to the scope of reversal, the part of the violation of the Medical Devices Act due to the advertisement of imported medical devices without permission or not reported to the Defendant Company should be reversed among the judgment below at the time of the exchange transmission. This is due to the use of unauthorized or unreported medical devices which was found guilty prior to the

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