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

The Defendant is the representative of “D” that imports and sells medical devices in accordance with the building C in Goyang-si, Manyang-si.

No one shall repair, distribute, lease, provide, or use a medical device that has obtained an import permit 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, around February 29, 2016, the Defendant: (a) received a request from the K-A-U.S. K-U. K-U.D. K-U.D. to supply F (G, Canada), a domestic medical device importer; (b) searched a foreign Internet site to verify the fact that the said product is used for purposes of rehabilitation, etc. for emotional and sexual patients; and (c) imported the said product from Denmark to the Korea Customs Service without filing a report, and sold it to E-U.S. K-U. by importing it as an industrial product that is not a medical device, without filing a report with the Commissioner of the Korea Food and Drug Administration; and (d) confirmed that it is used for purposes of rehabilitation, etc. for emotional and sexual patients.

Accordingly, the Defendant imported and sold medical appliances not reported to the Commissioner of the Korea Food and Drug Administration.

Summary of Evidence

1. The defendant's partial statement in the first protocol of trial;

1. A protocol concerning the examination of partial police officers of the accused;

1. Details of the official document on request for investigation, the import permit of medical device, the civil petition correspondence document (No. 11-15, 32-35, No. 11-15, No. 35), the business registration certificate, estimates, electronic tax invoices, the import declaration certificate

1. Application of the Acts and subordinate statutes of the Investigation Report (No. 6,8,11,16,41)

1. Relevant Articles 51 (1) and 26 (1) of the Medical Devices Act concerning criminal facts, and selection of fines;

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

1. The purpose of use of the product of this case for conviction under Article 334(1) of the Criminal Procedure Act, and the provisional payment order.