logobeta
본 영문본은 리걸엔진의 AI 번역 엔진으로 번역되었습니다. 수정이 필요한 부분이 있는 경우 피드백 부탁드립니다.
텍스트 조절
arrow
arrow
(영문) 인천지방법원 부천지원 2019.08.21 2019고단1609
의료기기법위반
Text

Defendants shall be punished by a fine of KRW 3,000,000.

Defendant

If A does not pay the above fine, it shall be 100.

Reasons

Punishment of the crime

1. Defendant A is a representative internal director of a stock company B established for the purpose of electronic commerce transactions, etc.

No one shall import and distribute any medical device that has not been permitted or certified, and shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device that has not been permitted or certified.

Nevertheless, from October 2018 to December 10, 2018, the Defendant imported “D”, which is a medical device not permitted or certified, from China, from the Chinese government, and advertised “E, F, G, H, I, J, K, K, L, and M”, and “D lux effect” and “D lux effect with a safe fluorma,” and sold the said D total amount to consumers KRW 5,89,891,440.

Accordingly, the Defendant advertised the performance and effects of D, which is a medical device not permitted or certified, and imported and sold D, which is a medical device not permitted or certified.

2. A, the representative of Defendant B’s Defendant, committed each act of violation as described in paragraph (1) with respect to the Defendant’s business.

Summary of Evidence

1. Defendant A’s legal statement

1. Examination protocol of the police officer against Defendant A and materials attached thereto;

1. The application of police investigation reports (medical product safety and attachment of a report to request the investigation of any person who has violated the Medical Devices Act, and the written request for investigation, business registration certificates, screen pictures for advertisements of medical devices not permitted or certified, current status of sales of medical devices not permitted or certified (D), statement of medical devices not permitted or certified, investigation reports (information submitted additionally as a suspect), and statutes governing D sales;

1. Article relevant to the facts constituting an offense and the selection of punishment;

A. Defendant A: Articles 52(1) and 24(2)5 (a) of the Medical Devices Act (a point of advertisement for a medical device that has not been permitted or certified).

arrow