의료기기법위반
The prosecutor's appeal is dismissed.
1. According to the evidence presented in the gist of the grounds of appeal, although Defendant A, an importer of medical device, can be recognized as having imported and sold the medical device, recognizing that the medical device was “Nerox Citchine,” and “Yerobbine,” as indicated in the facts charged, the lower court acquitted Defendant A of the charges of this case by misapprehending the facts or by misapprehending the legal doctrine, thereby adversely affecting the conclusion of the judgment.
2. Determination
A. The summary of the facts charged in the instant case is Defendant A’s representative director, and Defendant B is the company that manufactures and sells articles for the disabled, the aged, etc.
(1) The Defendant A may not repair, distribute, lease, award, or use a medical device without obtaining permission or filing a report.
Nevertheless, the Defendant imported and sold 19 medical devices that were not permitted through the E site operated by Company B, the representative director, from February 3, 2012 to January 2013, 2013, and 1533 of the “Nerox Citchine Citchine”.
(2) Defendant B Co., Ltd. committed the above violation in relation to the Defendant’s business at the above date, time, and place.
나. 원심의 판단 원심은, 원심이 적법하게 채택하여 조사한 증거들에 의하면, 이 사건 각 기구는 척수 장애인 등 배뇨활동이 어려운 남성 환자가 착용하여 소변을 받는 사용하는 제품으로서 소변 관 카테터를 착용하고 소변 백을 종아리 부분에 착용한 뒤 그 사이를 고무 튜브로 연결하며 소변 백 아래 부분에는 소변 배출 어댑터가 있어 소변이 차면 밸브를 열어 소변을 비울 수 있는 장치로 구성되어 있는 사실, 피고인 A은 이 사건 각 기구를 광고 하면서 척수 장애인들을 위한...