Defendant shall be punished by a fine of four million won.

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

Punishment of the crime

The Defendant is a substantial operator who has obtained permission to manufacture medical devices with the trade name “C” in Gangdong-gu Seoul Metropolitan Government, and manufactures, exports, and sells, “D, E,” etc., a medical device for export.

1. No one shall repair, distribute, lease, award, or use any medical device that has not obtained permission or certification, or has not filed a report, nor manufacture, import, repair, store, or display any medical device for the purposes of sale, lease, granting, or use;

Nevertheless, around September 2015 and around January 2, 2016, the Defendant manufactured a total of 10,000 products, “D(2), and E(F),” which were products reported to the food and drug wife only as “medical devices for export,” without obtaining permission or reporting as “medical devices” in Korea, and distributed and sold 4,280 market prices of 106,74,000 won from October 2, 2015 to August 2, 2016 through its Internet homepage (G).

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

2. No one shall advertise the name, manufacturing method, performance, efficacy, or effect of a medical device without obtaining permission or certification, or with respect to an advertisement of a medical device different from matters reported pursuant to Article 6 (2) or 15 (2) of the Medical Devices Act;

Nevertheless, from October 2015 to August 2, 2016, the Defendant sold medical appliances for export using six sites, such as “C”, “G” and “H,” “G Market (www.gmet.co. kr), “New.co. kr,” “New.co. kr,” “W. 11stm.co. kr,” and “W. 11m. co. kr,” and “W. m. (www.wem. w. e.co.co.co. e.co. kr)”, which are medical appliances for export, using six sites, including “D2,” “D2,” which are medical appliances for export, and products for efficacy and effects that have not been permitted or certified.”

Accordingly, the defendant is permitted or certified for domestic sales.