Abstract ▼

In Korea, clinical trial data may be needed when the purpose or principle of use of the applied product is different from that of the previously licensed product. In addition, if the performance or use method of the applied product is different from that of the previously licensed product, the need

In Korea, clinical trial data may be needed when the purpose or principle of use of the applied product is different from that of the previously licensed product. In addition, if the performance or use method of the applied product is different from that of the previously licensed product, the need for clinical trials is determined based on the characteristics of the product or the decision of the review department. Clinical trials of medical devices are usually conducted only one cycle in a controlled environment, resulting in a lack of information about their use across the whole cycle in medical device use, which limits safety and performance analysis.

On the other hand, in Europe, clinical evaluation reports for all grades of medical devices are mandatory, and clinical evaluation has been strengthened with the introduction of MDR, and the International Medical Device Regulatory Authority Forum(IMDRF) has established guidelines for clinical evaluation. In addition, in the United States, data base of reporting side effect is well used in the follow-up management system for medical devices, and a clinical evaluation system for medical devices based on real-world evidence has recently been proposed. Accordingly this study was conducted to help change the medical device license system to meet global standards and establish a whole cycle management of medical device system through the introduction of a clinical evaluation system in Korea.

In order to introduce a domestic clinical evaluation system, we first investigated the collection of RWE(Real world Evidence) related to the clinical evaluation in Europe, the United States and Japan through scoping review. In addition, medical device manufacturers and importers were surveyed on the perception of the introduction of clinical evaluation for domestic medical devices as well as opinions of experts and related ministries were considered, which resulted in the preparation of introduction plan of clinical evaluation system for domestic medical device

For the successful introduction of the domestic clinical evaluation system, a clinical evaluation manual(draft) and a review guide(draft) were prepared, and educational textbooks(draft) were produced for each manufacturer and reviewer. In addition, the social, economic, and technological impact of the introduction of the domestic clinical evaluation system was extensively analyzed, with decision-making and manufacturer support program proposed, and a step-by-step road map prepared.

This study was conducted to establish an efficient management system for medical device safety that can meet the international trend of changes and pro-actively respond to them in the medical device system. It is also expected to strengthen the capabilities of medical device reviewers through improvements in medical device-related systems, which will help the primary consumers of medical devices, the final consumers of the public as well as the industry, and ultimately contribute to health improvement and national prosperity.

(source : Summary 9p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 목차 ... 4
• Ⅰ. 총괄연구개발과제 요약문 ... 6
• 국문 요약문 ... 6
• Summary ... 9
• Ⅱ. 총괄연구개발과제 연구결과 ... 12
• 제1장 총괄연구개발과제의 목적 및 필요성 ... 12
• 제2장 총괄연구개발과제의 내용 및 방법 ... 30
• 제3장 총괄연구개발과제의 최종결과 및 고찰 ... 38
• 제4장 총괄연구개발과제의 연구성과 ... 304
• 제5장 총괄주요연구 변경사항 ... 306
• 제6장 총괄참고문헌 ... 307
• 제7장 총괄첨부서류 ... 312
• 끝페이지 ... 1214