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(영문) 서울중앙지방법원 2013.04.25 2012노3966

의료기기법위반등

Text

The defendant's appeal is dismissed.

The request for adjudication on the constitutionality of the instant case is dismissed.

Reasons

1. Summary of grounds for appeal;

A. misunderstanding of facts or misunderstanding of legal principles as to the violation of the Medical Devices Act 1) The Defendant did not have manufactured, used, or awarded reusable medical seals. 2) The Defendant’s products manufactured, used, or awarded are not considered medical devices or are not subject to the Medical Devices Act.

3) The Defendant did not have any awareness of illegality as to the fact that the products he manufactured, used, or conferred by himself constitute a medical device that was not reported as manufactured items and thus constitutes a violation of the Medical Devices Act. (B) Of course, misunderstanding of facts or misunderstanding of legal principles as to the aiding and abetting of Violation of the Medical Devices Act; (3) The combined composition of a medical device manufactured by J cannot be deemed as

2. There was no perception that the defendant aids and abets the violation of the J's Medical Devices Act.

2. Determination:

A. As to the assertion of misunderstanding of facts or misapprehension of legal principles as to the violation of the Medical Devices Act, it is sufficient that a certain organization, etc. uses it for the purpose prescribed in Article 2(1) of the Medical Devices Act (see, e.g., Supreme Court Decision 96Do3460, Mar. 14, 1997). According to the evidence duly examined and adopted by the court below, it is sufficient to recognize the fact that the Defendant’s use of plastic materials, such as plastic materials, etc. corresponding to class 1 medical appliances, which constitute “the manufacture of plastic materials” without reporting the use of “the manufacture of plastic materials” for the purpose of inserting the Defendant’s physical structure (in particular, co-structure’s structural structure) into a raw body by injecting it into a raw body through injecting it.