[1] Criteria for determining whether a medical device constitutes medical appliances under the former Pharmaceutical Affairs Act

[2] The case affirming the judgment of the court below which held that a bath tank which has the function of installing a baby for plastic bath and forming a water rope including the hair inside a bath tank by the action of the mother does not constitute medical appliances

[1] In order to fall under medical appliances designated by the Commissioner of the Korea Food and Drug Administration under Article 2 (9) of the former Pharmaceutical Affairs Act (amended by Act No. 6909 of May 29, 2003), even if an imported medical appliances have objectively the performance prescribed in the above provision, or do not have objectively such performance, it shall be recognized that they are used for the purpose prescribed in the above provision, comprehensively taking into account the structure and form of the apparatus, its purpose of use and effect, propaganda of the object of sale and its explanation at the time of sale, etc. Therefore, it shall not be viewed as medical appliances unless they have objectively the performance prescribed in Article 2 (9) of the same Act or are used for the purpose prescribed in the above provision.

[2] The case affirming the judgment of the court below which held that a bath, which has the function of installing a boiler for plastic bath and forming a water rope including the hair inside the bath tank by the action of the mother, is merely higher than raising the efficiency of bath and the commercialization as a bath, and it does not constitute medical appliances because it does not constitute medical appliances because it has objectively the function as a "medical appliances, which are designated by the Commissioner of the Korea Food and Drug Administration," or because it is difficult to view it as being used for such purpose.

[1] Article 2 (9) of the former Pharmaceutical Affairs Act (Elimination by Law No. 6909 of May 29, 2003) / [2] Article 2 (9) of the former Pharmaceutical Affairs Act (Elimination by Law No. 6909 of May 29, 2003), Article 2 [Attachment 1] of the Regulations on Designation, etc. of Medical Appliances

[1] Supreme Court Decision 92Do811 delivered on March 12, 1993 (Gong1993Sang, 1190), Supreme Court Decision 96Do3460 delivered on March 14, 1997 (Gong197Sang, 1161)

Defendant 1 and one other

Prosecutor

Seoul Central District Court Decision 2004No2570 Delivered on November 19, 2004

All appeals are dismissed.

We examine the grounds of appeal.

Article 2 (9) of the former Pharmaceutical Affairs Act (amended by Act No. 6909 of May 29, 2003) provides that "medical appliances" shall be used for the purpose of diagnosis, treatment, mitigation, treatment or prevention of diseases of people or animals, and those designated by the Commissioner of the Korea Food and Drug Administration as appliances, machinery or equipment used for the purpose of affecting the structure and function of human beings or animals. Article 34 (1) provides that "medical appliances" shall be permitted or reported by the Commissioner of the Korea Food and Drug Administration for each item under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. Article 74 (1) 1 provides that "the person who intends to import medical appliances shall be subject to criminal punishment against a person who violates Article 34 (1)." Article 2 (9) of the same Act provides that "medical appliances" shall not be objectively recognized as having the performance prescribed by the above Article 2 (9) of the Pharmaceutical Affairs Act, or shall not be objectively recognized as having the function and function of the above Article 9 (13) of the Pharmaceutical Affairs Act.

원심판결 이유에 의하면 원심은, 약사법 제2조 제9항 의 위임에 따라 식품의약품안전청이 고시한 '의료용구의지정등에관한규정' 제2조 [별표 1] A16130에서는 '수요법 장치(Hydrotherapeutic equipment)'를 의료용구로 지정하면서 '수요법 장치'에 대하여 "물, 온수, 증기 등을 가압 또는 와류하여 피부자극, 통증의 완화, 소양증 및 외상치료의 보조로 사용되는 기구, 분만용 욕조를 포함한다."고 규정하고 있는데, 이 사건 욕조는 플라스틱제의 욕조에 모터를 장착하고 모터의 작용에 의해 욕조 내부에 기포를 포함한 물줄기를 형성하게 하는 기능을 가진 제품으로서 위와 같이 형성된 기포가 포함된 물줄기에 의해 피부나 근육을 자극하여 피로 회복, 긴장 완화 등의 작용을 하는 사실, 피고인 1이 일본 잭슨(jaxon)사로부터 수입하여 판매한 이 사건 욕조는 대부분 고급빌라, 주상복합건물 등에 설치되었으며, 위 피고인이 경영하는 피고인 2 주식회사(이하 '피고인 회사'라 한다) 역시 고급빌라, 주상복합건물, 모텔 등을 그 판매대상으로 하고 있을 뿐 의료기관을 대상으로 하고 있지 아니한 사실, 피고인 회사에서 제작한 광고팜플렛에 인쇄된 이 사건 욕조에 대한 제품 설명은 "잭슨사의 욕조가 제공하는 기포욕은 피로하기 쉬운 근육을 풀어주며 피로물질을 효과적으로 제거하는 마사지효과, 온열효과, 긴장완화 등의 진정작용, 세정효과가 있고, 이와 같은 기포욕은 '하이드로 세라피'라고 하는 수압을 이용한 치료법에도 채용되고 있습니다."라는 내용으로서 특정 질병의 치료ㆍ예방이나 인체의 구조ㆍ기능에 영향을 미친다는 내용은 아닌 사실을 인정할 수 있으므로, 이 사건 욕조는 피부나 근육을 자극하여 단순히 피로 회복, 긴장 완화 등의 작용을 하는 제품일 뿐 이와 달리 사람 또는 동물의 질병의 진단ㆍ치료ㆍ경감ㆍ처치 또는 예방의 목적이나 사람 또는 동물의 구조ㆍ기능에 영향을 주기 위한 목적으로 사용되는 것으로 볼 수 없다고 판단하여, 무허가 의료용구 수입죄로 기소된 이 사건 공소사실에 대하여 무죄를 선고하였다.

In light of the records, the court below's above fact-finding is just, and if the facts are identical to this, in light of the above legal principles, the bath of this case merely enhances the efficiency of bathing and the commercialization as a bath, and it is difficult to objectively have the function as a "demanding Devices" designated by the Commissioner of the Korea Food and Drug Administration pursuant to Article 2 (9) of the Pharmaceutical Affairs Act, or to view it as being used for such purpose. Thus, the court below's decision that the bath of this case does not constitute medical appliances under Article 2 (9) of the Pharmaceutical Affairs Act is just, and there is no error of law such as misunderstanding of facts against the rules of evidence or misunderstanding of legal principles as to the interpretation of medical appliances under Article 2 (9) of the Pharmaceutical Affairs Act.

As otherwise asserted in the ground of appeal by the prosecutor, even though the defendant company includes the wholesale and retail business of medicines and medical appliances for the business purpose of the defendant company, and the company importing the bath with pressure and confection function with permission from the Commissioner of the Korea Food and Drug Administration, it includes the trade business, distribution business, wholesale and retail business of construction materials for the business purpose of the defendant company (the trial record page 31), and there is no evidence to find that the bath for which permission from the Commissioner of the Korea Food and Drug Administration granted is identical with the bath of this case and its function and purpose of use. Thus, the above circumstance alone cannot be seen as constituting medical appliances. The argument in the grounds of appeal cannot be accepted.

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

Justices Kim Yong-dam (Presiding Justice)