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(영문) 서울남부지방법원 2020.09.25 2020고정1488

의료기기법위반

Text

Defendant shall be punished by a fine of KRW 5,000,000.

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

Reasons

Punishment of the crime

No one shall repair, distribute, lease, provide, or use any medical device that has obtained permission or certification, or has failed to file a report, or manufacture, import, repair, store, or display a medical device for the purposes of sale, lease, provision, or use.

Nevertheless, from October 5, 2019 to February 15, 2020, the Defendant manufactured the total amount of KRW 54 million, which is a medical device that did not obtain permission or certification, with the trade name called Guro-gu Seoul Building B and C, and “D,” and sold KRW 87,40,000 in total.

Summary of Evidence

1. Defendant's legal statement;

1. An interrogation protocol of F;

1. A written accusation;

1. Confirmation of manufacturers of investigative reports (E).

1. Application of Acts and subordinate statutes on apparatus photographs (marked matters), apparatus monitoring screen pictures (hereinafter “E”), copy of operating manual, business registration certificate, list of purchased electronic tax invoices, trademark registration notice, trademark registration notice, E sales details, and sales account books and photographs;

1. Relevant provisions of relevant Acts concerning criminal facts and Articles 51 and 26 (1) of the Medical Devices Act that choose a penalty;

1. Articles 70 (1) and 69 (2) of the Criminal Act for the detention of a workhouse;

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