Defendant

A is the representative director of Defendant B, Inc., who is the manufacturer of medical devices located in Kuju-si.

1. Defendant A

(a) No person who violates Article 26 (1) of the Medical Devices Act shall manufacture, import, repair, store, or display any medical device without obtaining permission or filing a report for the purpose of repairing, selling, leasing, granting, or using it;

Nevertheless, around July 25, 2013, the Defendant sold one “E”, which is a medical device that has not obtained permission from the Minister of Food and Drug Safety, to F. (2) around September 10, 2013, the Defendant sold one “E”, which is a medical device that has not obtained permission from the Minister of Food and Drug Safety, to G, a foreign company, and (3) around December 3, 2013, sold one “E,” which is a medical device that has not obtained permission from the Minister of Food and Drug Safety, to H, a foreign company. (2) On the container, outer package, package, package, or package of the medical device in violation of Article 24(1) of the Medical Devices Act, the Defendant did not indicate or indicate any false or misleading matter with respect to the relevant medical device, as if the Defendant had failed to obtain permission from the Minister of Food and Drug Safety, as stated in subparagraph (a) of Article 24(1) of the Medical Devices Act, and indicated one “EF,” as if the Defendant had sold the medical device, 213g.

2. Defendant B

A. On July 25, 2013, around September 10, 2013, and around three occasions on December 3, 2013, the Defendant, a representative of the Defendant, committed a violation as referred to in Article 1(a).

B. Around July 25, 2013, the Defendant, the representative of the Defendant, committed a violation under Article 1(b) with respect to the Defendant’s business.

Summary of Evidence

1. Defendant A’s legal statement

1. The statement of M;