초록

본 연구개발과제 「첨단 융복합 의료기기 신속제품화 허가지원을 위한 전략적 가이드라인 마련 연구」의 결과물로서 개발된 가이드라인은 국내 첨단 융복합 의료기기 개발제품의 수출 증진 및 국제경쟁력 제고에 활용될 수 있도록 다부처 R&D개발부터 허가, 국제규격, 임상시험, 시험검사, 부작용 사례정보, 주요 수출국 인허가 정보, 통관정보 등 종합적인 정보를 수집‧분석‧제공하고 있으며 가이드라인 활용성을 높이기 위해 인허가 주기별 정보 콘텐츠 활용(안)을 제시하고 있음

Abstract ▼

The guideline, which is developed as an output of the R&D project entitled 「A study to establish a strategic guideline for support of approval of fast-commercialization in high-tech convergence medical device」, is intended to collect, analyze, and provide total information from multi-department R&D

The guideline, which is developed as an output of the R&D project entitled 「A study to establish a strategic guideline for support of approval of fast-commercialization in high-tech convergence medical device」, is intended to collect, analyze, and provide total information from multi-department R&D to approval, international standards, clinical trials, testing & inspection, information of adverse events, regulatory information of major exporting countries, customs information, etc., so that they can be utilized in promoting the export of internally developed high-tech convergence medical device and raising the international competitiveness, as well as to suggest a (draft) for utilization of information contents by regulatory cycle in order to enhance availability of the guideline.