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(영문) 수원지방법원 2018.08.09 2018고정932
의료기기법위반
Text

Defendant shall be punished by a fine of KRW 700,000.

When the defendant does not pay the above fine, 100,000 won.

Reasons

Punishment of the crime

The defendant is a person who operates D in Suwon-si C and fourth floor.

No one shall put a mark on an outer package, package, or appended document of any appliance, other than a medical device, that is likely to mislead any person to believe that the appliance has a performance, efficacy, or effect similar to that of a medical device, or place an advertisement with such misleading content.

Nevertheless, the Defendant, on May 26, 2017, sold E in Suwon-si C and D around Suwon-si on May 26, 2017, without being registered as a medical device, the fact that the Defendant sold E is not a medical device, but a medical device, the Defendant “low-Shee Newcom is well in the blood cycle and has good function.”

파킨슨병으로 막 흔드시는 분도 좋아지고 에어 쇼 바라는 완충장치 등으로 발을 자극하여 하지 정맥류 때문에 땡기고 아픈 분들이나 근력이 약하신 분이 신었을 때 근육을 튼튼하게 해 드린다, 혈액순환이 되지 않는 분들이 혈액순환이 되는 제품을 신겨 드리니까 혈관이 확장되면서 발이 따끈따끈 해지고, 신경외과나 정형외과 교수님들이 처방전을 갖고 온 사람만 맞춤으로 신겼어요.

Nr. He has undergone a multi-test test and passed a multi-test like the Do Clinical Test of the Do.

“.....”

Accordingly, the defendant made an advertisement that could be mistakenly perceived as being used for the purpose of treating illness or disability as a medical device.

Summary of Evidence

1. Statement by the defendant in court;

1. Complaint;

1. Application of Acts and subordinate statutes governing recording records;

1. Relevant Article 52 of the Medical Devices Act, Articles 52 (1) 1 and 26 (7) of the same Act concerning criminal facts, the selection of fines, and the selection of fines;

1. Article 70(1) and Article 69(2) of the Criminal Act to attract a workhouse;

1. Although the sentencing of Article 334(1) of the Criminal Procedure Act was imposed on a criminal defendant who committed a crime of violating the Medical Devices Act, the fact that the criminal defendant again committed the instant crime is disadvantageous.

However, the defendant is wrong.

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