임상적 관점에서의 의료기기 관리제도 개선방안 연구

Clinical evaluation is a very important procedure for the safety and effectiveness management of medical devices. However, unlike the pharmaceutical field, the systematic procedure to assess clinical safety and effectiveness of medical device has not been established due to the characteristics of medical devices such as the class of medical device according to potential risks, various treatment environment, and the specificity of indications in the view of regulatory process. In the United States and Europe, the clinical evaluation system is continuously being improved with the rapid development of advanced technologies and continuous emergence of innovative medical devices. Considering that Korea has not only been struggling to establish the proper clinical evaluation system of medical devices since the introduction of substantial equivalent concept of FDA in 2001 but also is in the same medical device industry environment, it is also highly needed to review the previously introduced clinical evaluation system and to improve it in global regulatory perspective. As a result of comparison to the United States and Europe, Korea will need a differentiated clinical data evaluation system by medical device classes and the method to analyze effectively clinical data collected in more diverse sources such as clinical reviews in the filed of medical technology. The improvement of the clinical evaluation system will ultimately establish an effective clinical data evaluation system throughout the total life cycle of medical devices to be enable interconnecting the pre-market & post-market clinical evaluation system in Korea. It is expected that the safety management of medical devices will be strengthened through the improvement of the clinical evaluation system for medical devices, and that will be able to respond more effectively to the future medical environment.