A shall be punished by a fine for negligence of KRW 15,00,000 and by a fine of KRW 30,000,000, respectively.

Defendant

A above.

Defendant

A is the representative director of Yeongdeungpo-gu Seoul Metropolitan Government Group C7, and Defendant B is a corporation with the purpose of research, development, manufacture, and distribution of electronic medical devices.

1. When the head of a customs office files a report on the name, size, quantity, and price of the relevant goods and other matters prescribed by Presidential Decree to import medical appliances under Defendant A's Medical Devices, he/she shall obtain prior permission from the Minister for Food and Drug Safety and obtain a certificate of receipt of standard customs clearance scheduled report from the head of the Korea Medical Devices Industry Association at each time of importation, and shall not obtain necessary permission, approval, recommendation, certification, or other conditions under the aforementioned Acts and subordinate statutes or shall not be imported in an unlawful manner;

Since “medical image transmission device software” imported by the Defendant is a class 2 medical device, the imported product must be imported after obtaining permission from the Minister for Food and Drug Safety for each item, and the President of the Korea Medical Device Industry Association shall prepare a standard customs clearance schedule by electronic document exchange method at each time of importation.

On March 6, 2012, through the Incheon International Airport located in Jung-gu Incheon Metropolitan City, Jung-gu, Incheon Metropolitan City, the Defendant filed an import declaration (number F) with the head of the Incheon Airport to import an amount equivalent to KRW 1 software for medical image transmission devices, KRW 28,421,750, E, E, from the Incheon International Airport.

The model to be imported from that model was a model that was approved by the Minister of Food and Drug Safety from January 24, 201 as 11 to 11-123 (BER 5.1, 3.1.1.) and changed in the function such as automation of the image removal function of the two parts and the half sides and the half sides and improvement of the blood-related analysis function (BER 6.2.1.1.) so in order to import it, the revised license was newly obtained.

the United States.

However, the defendant submits data necessary to permit the change in the U.S. D. D.