Defendants shall be punished by a fine of KRW 2,000,000.

Defendant

A fails to pay the above fine; 50.

Punishment of the crime

1. Defendant B is a corporation established for the purpose of operating the manufacturing and distribution of medical supplies in Gwangju North-gu, Gwangju, and Defendant A is the representative director of the said corporation.

2. Defendant A

(a) No person who sells an unauthorized medical device shall repair, distribute, lease, provide, or use a medical device without obtaining permission from, or filing a report with, the competent authority;

Nevertheless, around April 2012, the Defendant manufactured 982 dental appliances fixings (HA surface processing method) for dental appliances that were not permitted for domestic sales in the above corporation B, and sold them to the domestic medical device sales chain (main).

(b) A manufacturer of medical appliances, such as quality control records, shall prepare and keep documents on the input and release of finished products, manufacturing process and quality control;

Nevertheless, at around October 23, 2012, the Defendant did not prepare and keep documents on quality control, such as the date of production, the date of storage, the register of finished products such as inventory ledgers, and the written request for sterilization, the statement of spawn performance, etc.

3. The Defendant B, at the date, time, and place of Paragraph 2, sold without permission medical devices and did not keep quality control records, as described in Paragraph 2, in relation to the Defendant’s business.

Summary of Evidence

1. Defendants’ respective legal statements

1. Examination protocol of Defendant A by the prosecution;

1. E. Each prosecutor’s statement concerning F;

1. Application of Acts and subordinate statutes to an investigation report (a written indictment attached);

1. Defendant A related to criminal facts: Articles 51(1) and 26(1) of the Medical Devices Act (which means the sale of unauthorized medical devices), Articles 52(1)1 and 13(1) of the Medical Devices Act (which is lack of documents related to entry and delivery of finished products, manufacturing process, and quality control), respectively;