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(영문) 서울서부지방법원 2017.11.03 2017고정228

의료기기법위반

Text

1. The defendant shall be punished by a fine of 800,000 won;

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

Reasons

Punishment of the crime

From February 2, 2014 to August 2016, the Defendant: (a) at the D Office of the Defendant’s operation of Yongsan-gu Seoul Metropolitan Government, Yongsan-gu and 205, with respect to “medical device’s website (welve-1694) that obtained permission to manufacture a medical device (No. 12-1694)”, without undergoing deliberation by the Director General for Food and Drug Safety on Internet advertisements; and (b) unlike the matters permitted to manufacture a medical device, the Defendant compared the contents of the equipment for treatment, such as -AT end-line for treating hirical disks without surgery; and (c) “3D-tension system for treatment” to reduce the escape of nuclear technology and increase the blood circulation on the vert paper so that nutrition and oxygen, etc. can be moved to a disc; and (d) “the only method for treatment after treatment,” such as treatment, treatment, treatment, etc., can be resolved by posting the disk’s height to its original location after treatment and pressure.”

Accordingly, the defendant, without undergoing an advertisement review, advertised the performance, efficacy, and effect of the above medical device different from the permitted matters, and advertised by using photographs that suggest the performance, efficacy, and effect of the medical device.

Summary of Evidence

1. Statement by the defendant in court;

1. Printeds on each website;

1. Application of the Acts and subordinate statutes on the written accusation;

1. Relevant provisions of the Medical Devices Act concerning criminal facts, and Articles 52(1)1, 24(2)3 (including the advertisement of a medical device using visual methods, including the advertisement of a medical device), 52(1)1, and 24(2)5 (including the advertisement of a medical device, including the performance, etc. for which permission has not been granted), and Article 52(1)1, and 24(2)6 (including the advertisement of a medical device, etc.) of the same Act concerning the selection of fines, respectively;

2. The former part of Article 37 of the Criminal Act, Articles 38 (1) 2 and 50 of the same Act, which increases concurrent crimes;

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

4. Article 334 (1) of the Criminal Procedure Act concerning the order of provisional payment.