ISO 국제표준의 비교 연구를 통한 의료기기 임상시험 기반구축 방안에 대한 연구

Abstract

Market of medical device is increased and the needs of new device development is also increased. Remarkable development of Biotechnology is triggered by the clinical application and feasibility in various sectors such as in investigational drug, medical device. Due to the special characteristic of clinical research, clinical research must be designed and conducted ethically as well as scientifically. Also, such clinical trials require us to comply with the internationalized standard procedure and criteria.

However, if we look at our environment, infra or experience of clinical trial of medical device is little compared with developed countries. Even domestic companies request abroad clinical trial centers to conduct clinical trials if they want to export the products. Therefore, improvement of infrastructure of clinical trials is needed.

The medical device industry, domestic and international competitiveness are required as a means of securing a GMP and ISO international standard that is based on a comparison of the reviews, medical device clinical trials based on the need of building solutions.

Medical device manufacturers are required to compare them with the relevant international standards(ISO 9001:2015, ISO 13485:2003, ISO 14971:2012, ISO 14155:2011), especially compared to the domestic and foreign medical device clinical trial management system, research results are as follows.

Domestic GMP quality system standard ISO 13485: 2003, and fully matched to the international standard, and you want to build a systematic quality management system for medical devices adopting the standard. In addition, international trends, even in the United States and Europe of the ISO 13485: 2003 for medical devices regulatory agencies is based on the international standards GMP system, seeking to promote the standardization of the MOU so that now the ISO 13485: 2003 standard, South Korea as well as from around the world for medical devices will be spread to the GMP standard.

International standard ISO 14971 risk management: 2012 based on medical devices in the field of risk management to medical devices quality management system by applying the necessary element of medical equipment will play a large part in risk management enhancement.

Domestic clinical trial of drugs in the Center's drug-driven clinical trials actively underway in the medical device field in the system's characteristics, it is difficult to perform a clinical trial reflected enough. This ISO 14155: 2011 through advanced domestic standards relating to medical device clinical trials based on the need of building. In addition, an international clinical trial scheme by comparison, in developed countries, there are a lot of authority and responsibility to the IRB has given more, review, approval, reporting, etc., could see that more reasonable procedures and institutions. In addition, a variety of continuing education systems exist, so a variety of training programs will have to be improved upon in the development.