2018 High Court Order 1643 Violation of Medical Devices Act

A

Pursuant to the reasoning of the lower judgment, the lower court erred by misapprehending the legal principles on the grounds of appeal.

Law Firm Driedul

[Defendant-Appellee]

December 22, 2020

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

When the defendant fails to pay the above fine, the defendant shall be confined in a workhouse for the period converted into one day.

In order to order the provisional payment of an amount equivalent to the above fine.

Criminal facts

The defendant is a person who distributes a medical device.

No person shall make a false or exaggerated advertisement on the name, manufacturing method, performance, efficacy, effect, or principle of a medical device while advertising a medical device.

Nevertheless, on October 18, 2017, the Defendant advertised to sell “C,” which is a medical device with the performance of fluorization in B press on January 26, 2018, on the B press 28 pages, and on January 26, 2018, the Defendant advertised to sell “C,” which is a medical device with the performance of fluorization of fluorization, as if the Defendant had the performance of treating the pre-fluoring line, and falsely treated the pre-fluoring line in accordance with the pre-fluoring line.

Summary of Evidence

1. Partial statement of the defendant;

1. Statement made to D by the police;

1. The main sentence of an official document and field photographs, a statement of sale of medical devices, a comparison chart and writing between imported E and C in Korea;

1. Application of Acts and subordinate statutes governing permission for import of medical appliances, such as a written accusation, civil petition consultation, two copies of advertisements, written confirmations, import item permission for medical appliances, B press advertisements advertisedd by a suspect, civil petition application page closures by the Ministry of Food and Drug Safety, closures of the F search screen, closures of the F homepage, medical device import license, and medical appliances and medical appliances;

1. Article relevant to the facts constituting an offense and the selection of punishment;

Articles 52(1)1 and 24(2)1 of the Medical Devices Act, selection of fines

1. Aggravation for concurrent crimes;

Articles 37 (former part), 38 (1) 2, and 50 of the Criminal Act

1. Invitation of a workhouse;

Articles 70(1) and 69(2) of the Criminal Act

1. Order of provisional payment;

Article 334(1) of the Criminal Procedure Act

Judgment on the argument of the defendant and defense counsel

1. Summary of the assertion

The defendant asserts that the medical device was advertised for the treatment of pre-user diseases, and that C was not advertised in order to sell it as pre-user treatments.

2. Determination

Comprehensively taking account of the following facts and circumstances acknowledged by the evidence duly adopted and examined by this court, the fact that the Defendant, who was permitted to manufacture a medical device for the purpose of relaxing the general public’s body, was falsely advertised to the general public as if the Defendant had special efficacy and effect on the pre-permanent disease. The assertion by the Defendant and the defense counsel is without merit.

① The Defendant advertised each of the instant newspapers with the following contents: “The full refund of the pre-paid vessel in full, scientific 43°Cratise and dratise, this treatment method has no side effect and can be used in a safe and oral manner, and thus, the Defendant has the right to receive a pre-fratative therapy, which can see the rapid effect within one month.”

② The Defendant asserts that the instant advertisement had been sold E or C at his option to the consumers who asked about the pre-user pre-user treatment machines. However, the Defendant only sold C only to the pre-user treatment machines from September 15, 2017 to May 15, 2018, but did not sell E at all.

③ Meanwhile, E is a product that has obtained permission for import with a personal hot-calorie for the purpose of chronic renal failure, electric renal failure, and dypology treatment. On the other hand, C sold by the Defendant is a product that has obtained permission for import with a personal hot-calorie for the purpose of relaxing the dypology.

(4) Even according to the statement and self-written statement prepared and submitted by the Defendant to an investigation agency, the Defendant asserts that “E is a product with a lot of clinical trials (preliminary results) in 193, but it is highly problematic that it does not meet the criteria for the permission of the food and medicine center, and C is a superior pre-service medical device than E.

⑤ In addition to the instant advertisement, the Defendant’s Internet homepage (H) searchs the entry of “G” or “F” recorded in the said advertisement, and the Defendant sells only C with products for treatment, such as pre-sponsor, pre-sponsor, salt farm, etc., on the said Internet homepage, and there is sufficient possibility that the said products might be mistaken for the general public as if they were capable of treating all kinds of diseases on the pre-sponsor line.

Judges, President President, etc.