The judgment of the court below is reversed.

Defendant shall be punished by a fine of KRW 500,000.

The above fine shall not be paid by the defendant.

1. Although whether an appeal has undergone an evaluation under Article 53 of the Medical Service Act or not, it shall mean whether it has received “safety and effectiveness” as to whether it has been recognized, the lower court determined that the Defendant was acquitted of the facts charged in this case by misapprehending the legal doctrine on the evaluation under Article 53 of the Medical Service Act.

2. Determination

A. Article 56(2)1 of the Medical Service Act provides that no advertisement shall be placed on “new medical technology which has not undergone the assessment under Article 53”.

Article 53 (1) of the Medical Service Act provides that "The Minister of Health and Welfare shall conduct an assessment of the safety, effectiveness, etc. of new medical technology (hereinafter referred to as "new medical technology assessment") after deliberation by the Committee for Evaluation of New Medical Technology under Article 54 in order to protect national health and promote the development of medical technology, as prescribed by Presidential Decree." Article 53 (2) of the same Act provides that "The Minister of Health and Welfare shall conduct an assessment of the safety, effectiveness, etc. of new medical technology under paragraph (1) of the same Article."

The term “those recognized” refers to those recognized.

In light of the relationship between the above provisions and the language and text thereof, Article 53(2) of the Medical Service Act is not a provision that generally defines new medical technology, but rather a provision that sets the requirements or prior examination procedure to be subject to new medical technology assessment by the Evaluation Committee under Article 53(1) of the Medical Service Act.

Therefore, the "evaluation under Article 53" under Article 56 (2) 1 of the Medical Service Act is an evaluation set forth in Article 53 as it is, i.e., the head of the health and welfare division in charge of new health and medical technology evaluation.

As a result, the "new health technology evaluation" refers to the new health technology evaluation conducted after deliberation by the Evaluation Committee, and the Minister of Health and Welfare needs to assess new health technology.