A shall be punished by a fine of KRW 5,000,000, and by a fine of KRW 3,000,000.

Defendant

A above.

1. Defendant A is the representative director of Company B who obtained permission for medical device import business. A.

No person who imports an unauthorized medical device shall sell, lease, provide, or use a medical device without an item approval, or import it for the purpose of testing.

Nevertheless, on January 19, 201, through the Incheon International Airport located in Jung-gu Incheon International Airport located in Jung-gu, Incheon, the Defendant imported 3 boxes 32,961 won at the dutiable value of 100 Haakium 2,961 won, “Ticon Plumine 100 Haakium 100 BF),” and around March 21, 2011, through the above Incheon International Airport, the Defendant imported 3 boxes 3 km 33,134 won at the dutiable value of tacoium 100 Haakium 10 Haak BF,33,134 won, and on March 25, 2011, through the above Incheon International Airport, the Defendant imported dental substance “Ticon Manium 100 Haakium 100 Haakium 100 Ma23830 gal.

(b) A medical device that orders importation prohibition by the Commissioner of the Korea Food and Drug Administration shall not import or sell a medical device that has been ordered by the Commissioner of the Korea Food and Drug Administration as it is likely to cause serious damage to national health or have a fatal effect on national health.

Nevertheless, on April 28, 2011, the Defendant sold a total of 260 kilograms over 57 times from August 12, 2011, from that time to August 12, 2011, a medical device that ordered the Commissioner of the Korea Food and Drug Administration to prohibit importation as of June 12, 2009, because it exceeded 0.02wt, which is the base of beryllium content, at the office of a stock company B located in Jung-gu Seoul, Jung-gu, Seoul, Seoul.

C. (i) An importer of a medical device shall reflect the latest standard specifications set by the Commissioner of the Korea Food and Drug Administration, and shall be the facility.