의료기기법위반
Defendants are not guilty. The summary of the judgment against the Defendants is publicly announced.
1. The summary of the facts charged is that Defendant A is the representative director B, and Defendant B is the company that manufactures and sells articles for the disabled, the aged, etc.
Defendant
A No person shall repair, distribute, lease, provide, or use any medical device without obtaining permission or filing a report.
Nevertheless, the Defendant imported and sold 19 medical devices that were not permitted on February 3, 2012 to January 2013, 2013, via E site operated by Company B, the representative director of which he/she is the Defendant, and 1533 of “Nlocare rubber Citus”.
B. Defendant B, a representative of the Defendant at the above date, time, and place, violated the above provisions regarding the Defendant’s business.
2. Determination
A. (1) In determining whether Defendant A constitutes “medical device” under Article 2(1) of the Medical Devices Act, the organization, etc. should be used for the purpose prescribed in the above provision, and there is no need to consider whether the organization, etc. has objectively such performance. Moreover, the purpose of use of the organization, etc. should be determined by comprehensively taking into account the structure and form of the organization, the purpose and effect of use indicated therein, publicity or explanation at the time of sale, etc.
(See Supreme Court Decision 2008Do7688 Decided April 29, 2010, etc.). According to the health stand for the instant case, and the evidence duly admitted and examined by this court, each of the instant organizations, as products with male patients who have difficulty in urology activities, such as the dys and the disabled, wear urine cathers, wear urine cathers, wear urine cathers, wear urine cats, and then wear urine