Defendant

A shall be punished by a fine for negligence of KRW 30,000,000, and by a fine of KRW 300,000,000, respectively.

Defendant

A.

Punishment of the crime

Defendant

A is a person in charge of import and export of medical devices, customs clearance and permission while working as a vice president at B Co., Ltd. in the second floor of Mapo-gu Seoul Metropolitan Government, and Defendant B Co., Ltd is a corporation with the purpose of importing, exporting, and selling precision, electronic, and optical equipment.

Where anyone intends to import goods, he/she shall file a report thereon with the head of the relevant customs office on the name, standard, quantity and price of the relevant goods, and other matters prescribed by Presidential Decree, and in such cases, he/she shall not import goods without meeting requirements for permission, approval, recommendation, certification or other conditions necessary for import in accordance with statutes

1. On January 13, 2012, Defendant A filed an import declaration (I) with the head of Seoul customs office to import an amount equivalent to KRW 516,410,394 of the cost of an internal-use semiconductor 1 set forth in the German head office B (G) from the German head office (H) with B as a person without tax payment.

The above medical device intended to be imported is a medical device (class 3) with potential risk of serious symptoms, and unlike the content of the import license already obtained, there was a change in the essential software that added treatment options on October 201, 201, and thus, in importing such a medical device, the medical device must be imported with the permission of change from the Minister of Food and Drug Safety.

Nevertheless, the Defendant was issued a certificate of scheduled receipt of standard customs clearance based on the import permit already obtained, and subsequently imported the necessary conditions in accordance with the laws and regulations on the basis of such issuance.

In addition, from January 23, 2016 to January 23, 2016, the Defendant’s use, such as changes in raw materials that affect safety and effectiveness over a total of 20 times, such as No. 1 to No. 20 times a year of crime sight table 1 to No. 20.