Defendants shall be punished by a fine of two million won.

Defendant

If A does not pay the above fine, 100,000.

Punishment of the crime

Defendant

A is the actual operator of Defendant B Company.

1. No person shall put any mark, etc. that is likely to mislead any person to believe that an article other than a medical device has a performance, efficacy, or effect similar to a medical device on the outer package, a mark, or an accompanying document of an article that is not a medical device, or include any such misleading content in an advertisement, or distribute or lease, store, or display, for the purpose of selling or leasing, an article marked or advertised as such;

Nevertheless, on June 20, 2014 and October 22, 2014, the Defendant supplied 100 units of industrial products (market price equivalent to KRW 75 million) to C Medical Care Center on two occasions, and falsely indicated that “name: manual medical care bed, product identification number, and product identification number: D: for the purpose of use, the medical device bed, and the manual bed and used for patient treatment at a medical institution.”

2. Defendant B, in relation to his business, committed a violation as set forth in the preceding paragraph by Defendant A, a user.

Summary of Evidence

1. The defendant A's partial statement

1. A certificate of importation of a medical device (or a passive medical intrusion, D);

1. Application of Acts and subordinate statutes in the ledger of marketing approval (report) under Article B;

1. Defendant A who committed a crime: Article 52(1)1 and Article 26(7)1 of the former Medical Devices Act (Amended by Act No. 1430, Dec. 2, 2016; hereinafter the same shall apply) on Defendant B: Articles 55 and 25(1)1 of the former Medical Devices Act

1. The former part of Article 37 of the Criminal Act, Article 38 (1) 2, and Article 50 of the same Act for the increase of concurrent crimes;

1. Defendant A who is detained in a workhouse: Articles 70 (1) and 69 (2) of the Criminal Act;

1. The Defendant’s judgment as to the assertion of Article 334(1) of the Criminal Procedure Act regarding the provisional payment order is a medical device and thus, this crime is not established against the Defendant, as it is a medical device as stated in the facts charged (hereinafter “the instant intrusion”).

DaNN

According to the above evidence, Defendant E is a model name E and two cases (F.).