A. Criteria for determining whether a person falls under medical appliances under the Pharmaceutical Affairs Act

(b) Whether self-medical technicians designated by the Minister of Health and Welfare as medical appliances are also used for the purpose of influencing the structure or functions of human beings or animals (affirmative)

C. Whether a reply that is not medical appliances of the Minister of Health and Welfare may interfere with the judgment as to medical appliances (negative)

A. In determining whether the medical appliances designated by the Minister of Health and Welfare fall under medical appliances, it is sufficient to use them for the purpose prescribed in Article 2 (9) of the Pharmaceutical Affairs Act, and there is no need to consider whether they have objectively such performance. The purpose of use shall be determined by comprehensively taking into account the structure and form of apparatus, etc., the purpose and effect indicated, propaganda or explanation at the time of sale

B. It is reasonable to view that the bio-medical clinic products constitute at least an organization used for the purpose of affecting human functions, and that the self-medical clinic, which is a type of self-medical device that the Minister of Health and Welfare provides treatment using self-medical equipment designated as medical appliances, not only for the purpose of treating diseases, such as its name, but also for the purpose of affecting the structure or functions of human beings or animals by using electromagnetic waves or self-medical equipment. Therefore, bio-medical clinic constitutes medical appliances under the Pharmaceutical Affairs Act

C. The Minister of Health and Welfare responded to the fact-finding inquiry by the court below that the purpose of use and purpose of use of the medical clinic is unclear, and that it is not medical appliances on the ground that the specific and objective effect is insufficient, it cannot be deemed that the judgment of the court below is obstructive to the conclusion that it constitutes medical appliances under the Pharmaceutical Affairs Act.

Articles 2(9), 61, and 75(1) of the Pharmaceutical Affairs Act

A. Supreme Court Decision 84Do2892 delivered on March 12, 1985 (Gong1985,582) 89Do73 delivered on September 12, 1989 (Gong1989,1528) 90Do1236 delivered on October 16, 1990 (Gong190,2346)

Defendant

Defendant

Attorney Lee Ho-chul et al.

Seoul Criminal Court Decision 91No3762 delivered on March 17, 1992

The appeal is dismissed.

As to the grounds of appeal by defense counsel

Article 2 (9) of the Pharmaceutical Affairs Act provides that "medical appliances" shall be used for the purpose of diagnosis, medical treatment, mitigation, treatment, or prevention of human or animal diseases, and apparatus, machinery, or device designated by the Minister of Health and Welfare, which is used for the purpose of affecting the structure and function of human or animal diseases. In determining whether an institution falls under medical appliances designated by the Minister of Health and Welfare under the above provision, if it is used for the purpose of the above provision, it is sufficient that the institution, etc. is used for the purpose of the above provision, and there is no need to consider whether it has such performance objectively. Further, the purpose of use of the institution, etc. shall be determined by comprehensively considering the structure and form of the institution, its purpose and effect indicated therein, publicity or explanation at the time of sale (see Supreme Court Decision 84Do2892, Mar. 12, 1985).

According to the judgment of the court of first instance affirmed by the court below, the organization of this case, which was manufactured by the defendant, is a structure where electromagnetic waves are generated if it operates an prefabricated body using resistance devices, contact Denmark, etc., using its sound devices. As stated in the facts charged in this case, the defendant, as an organization that generates radio frequencies identical to the earth president, has designated as one of the self-medical appliances, which is the self-medical appliances for treatment by using electromagnetic or permanent self-medical devices, such as electromagnetic therapy devices on February 21, 1986, etc., where the frequency generated in the bareboat body is smooth rhythy, promoting blood cycle, promoting sexual humiliation and reproductive power, promoting sexual desire and reproductive power, thereby improving the health condition of the telegraph by continuous balp effects, and continuously selling them. On the other hand, the Minister of Health and Welfare, as well as the Ministry of Health and Welfare, designated the self-medical appliances as one of the self-medical appliances.

Therefore, it is reasonable to view that the above bio-medical device manufactured by the defendant constitutes at least an instrument used for the purpose of affecting human functions, and that the above self-medical device designated by the Minister of Health and Welfare as medical device includes not only the purpose of treating diseases, such as its name, but also the purpose of using electromagnetic waves or self-help force to affect the structure or functions of human beings or animals. As such, the above bio-medical clinic constitutes medical appliances under the Pharmaceutical Affairs Act. In the response to the inquiry of the fact-finding by the court below, the Minister of Health and Welfare does not interfere with the above judgment on the ground that the purpose and purpose of the use of the bio-medical clinic, etc. in this case is unclear, and it is not a medical device on the ground that the specific and objective effect is insufficient

The judgment of the court below to the same purport is just and there is no error of law by misunderstanding the legal principles as to medical appliances under the Pharmaceutical Affairs Act, as otherwise alleged. The arguments are without merit.

Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices on the bench.