Defendants shall be punished by a fine of KRW 1,000,000.

Defendant

If A does not pay the above fine, it shall be 100.

Punishment of the crime

Defendant

A is a representative director of Defendant B Co., Ltd. (hereinafter referred to as “Defendant Co., Ltd.”) in Kim Sea-si, and the Defendant Co., Ltd. is a corporation established for the purpose of importing medical devices.

1. A person who intends to engage in the business of selling or leasing Defendant A medical devices (hereinafter referred to as "distributor") or a person who intends to engage in the business of leasing (hereinafter referred to as "renter") shall report distribution business or lease to the head of a Si/Gun/Gu (referring to the head of an autonomous Gu) having jurisdiction over the location of his/her place of business, as prescribed by Ordinance of the Prime Minister;

Nevertheless, on November 2, 2015, Defendant A imported 504 re-reinfluent iron re-504, which is a medical device equivalent to 28,790,920 won in the city, through Busan port, and sold 608,5 stories in Gangnam-gu Seoul, Gangnam-ro, Seoul, 608, and 5 stories in the Han-gu, Seoul.

2. The Defendant Company sold a medical device without reporting the distribution business of the competent authority in relation to the Defendant Company’s business at the time and at the place specified in paragraph (1).

Summary of Evidence

1. The Defendants’ respective legal statements

1. Each legal statement of witness F and G in part;

1. Determination as to the assertion by the Defendants, and their defense counsel, of a copy of the certificate of notification on the distribution of medical devices, a copy of the goods supply agreement with H (State) and (State)B, a copy of the transaction specification issued by B (State November 2, 2015), a copy of the transaction specification (State November 2, 2015), a copy of the transaction specification (State November 2, 2015), and a copy of the tax invoice written around November 2, 2015.

1. Summary of the assertion

A. A person who intends to engage in the business of selling medical appliances pursuant to Article 17(1) of the Medical Devices Act shall file a report on the distribution business, but pursuant to Article 17(2)1 of the same Act, if an importer sells medical appliances imported by him/her to a person who handles medical appliances, the person need not file a report on the distribution business.

However, the defendant company.