The Innovative Medical Devices Group Designation System Guide is a data that explains the overall introduction of the Innovative Medical Device Group Designation System, the scope and procedure of designation, and how to apply. The main contents include the criteria and review procedures for determining the areas where the applied products are included among the detailed technology groups classified into 4* according to whether they are applicable to the innovative medical device group and the purpose of designation.
*According to the purpose of designation under Article 14 of the Enforcement Decree of the Medical Device Industry Act, it is classified into four high-tech groups, medical innovation groups, technology innovation groups, and public-interest medical groups
혁신의료기기군 지정 제도 안내서(Innovative Medical Devices Group Designation System Guide)는 ‘혁신의료기기군 지정 제도’에 대한 전반적인 소개와 지정범위 및 절차, 신청방법 등에 대하여 알기 쉽게 설명한 자료이다. 주요내용은 혁신의료기기군 해당 여부와 지정 목적에 따라 4가지*로 분류된 세부 기술군중 신청 제품이 포함되는 영역에 대한 판단 기준 및 검토 절차 등이다.
*의료기기산업법 시행령 제14조 지정목적에 따라 첨단기술군, 의료혁신군, 기술혁신군 및 공익의료군 4개로 분류
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| Created | 2020 |
| URI | http://bartoc.org/en/node/20662 |
| Homepage | https://www.khidi.or.kr/board/view?pageNum=1&rowCnt=20&no1=1&linkId=48848180&refMenuId=MENU01499&menuId=MENU01498&maxIndex=&minIndex=&schType=1&schText=%ED%98%81%EC%8B%A0%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EA%B5%B0%20%EC%A7%80%EC%A0%95%20%EA%B2%80%ED%86%A0%20%EC%A0%88%EC%B0%A8%20%EC%95%88%EB%82%B4%EC%84%9C%20%EB%B0%9C%EA%B0%84&schStartDate=&schEndDate=&boardStyle=&categoryId=&continent=&country= |
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