The punishment of the accused shall be determined by six months of imprisonment.

except that the sentence shall be imposed for a period of one year from the date the judgment becomes final and conclusive.

Punishment of the crime

No one shall repair, distribute, lease, award, or use any medical device that has not been permitted or certified, or has not been reported, nor shall he/she manufacture, import, repair, store, or display any medical device with intent to distribute, lease, provide, or use it.

Nevertheless, on December 3, 2015, from around May 10, 2017 to around May 10, 2017, the Defendant directly manufactured “D”, which is a medical device, without obtaining permission for manufacturing or obtaining certification, or filing a report, at the Defendant’s residence located in the former Northern-gun C, and sold a total of KRW 67,565,00 (195) as indicated in the attached crime list via “E” that the Defendant established.

Accordingly, the Defendant manufactured and sold an unauthorized medical device.

Summary of Evidence

1. Partial statement of the defendant;

1. A written statement of accusation against violators of the Medical Devices (including attached documents), on-site photographs, and a detailed statement of transactions with each agricultural cooperative head;

1. Application of the existing Acts and subordinate statutes of seized D (No. 1)

1. The pertinent legal provisions on criminal facts and Articles 51(1) and 26(1) of the Medical Devices Act’s option of punishment (in combination with, the choice of imprisonment) (hereinafter “D”) asserts to the effect that the Defendant and his defense counsel’s “D” does not constitute “medical devices” under Article 2(1) of the Medical Devices Act.

In determining whether a certain organization, etc. constitutes “medical device” under Article 2(1) of the Medical Devices Act, the organization, etc. is exempted from being used for the purpose prescribed in the said provision, and there is no need to consider whether it objectively has such performance. Moreover, the purpose of use of the organization, etc. should be determined by comprehensively taking into account the structure and form of the organization, the purpose and effect of use indicated therein, propaganda or explanation at the time of sale (see, e.g., Supreme Court Decision 2008Do7688, Apr. 29, 2010). The evidence duly adopted and examined by the court is as follows.