A defendant shall be punished by imprisonment for not less than eight months and by a fine not exceeding ten thousand won.

However, for a period of two years from the date this judgment becomes final and conclusive.

Punishment of the crime

From July 7, 1997, the Defendant is a person who manufactured and sold bills with the trade name “C” from Yeongdeungpo-gu Seoul Metropolitan Government B and the second floor.

1. No person who manufactures or sells non-certified medical devices shall repair, distribute, lease, provide, or use a medical device without permission or certification, or without reporting, or manufacture, import, repair, store, or display a medical device with intent to distribute, lease, provide, or use it;

Nevertheless, from January 4, 2017 to May 30, 2019, the Defendant manufactured approximately 1.25 medical appliances, which were not certified as manufacturing and selling medical appliances, at the above “C” office, and sold them to unspecified buyers in KRW 800,000 per unit.

2. No one shall advertise a non-certified medical device with respect to the name, manufacturing method, performance, efficacy, or effect of a medical device without a license or certification or with any indication different from those permitted or notified;

Nevertheless, the Defendant opened an Internet homepage (D) that introduces C at the above office around October 2015, and advertised the name, performance, etc. of a medical device, which was not certified as manufacturing and selling medical devices, from around that time to May 31, 2019.

Summary of Evidence

1. Defendant's legal statement;

1. Statement of public official;

1. Sales account books from January 2017 to May 2019;

1. Printeds on the C Internet homepage;

1. Application of Acts and subordinate statutes to report on investigation (verification subject to certification of an agenda item);

1. Relevant provisions of the Medical Devices Act concerning criminal facts, and Articles 51 (1) and (2), 26 (1) of the Medical Devices Act that choose a punishment (the overall control of manufacturing and selling non-certified medical appliances, and each of them shall be subject to a fine), Articles 52 and 24 (2) 5 of the Medical Devices Act (the point of advertising non-certified medical appliances, and the choice of imprisonment);

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

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