| Summary: | 碩士 === 中原大學 === 醫學工程學系 === 88 === Everybody has a close relationship with medication in his/her process of growth and fading. The medical device is a leading player in diagnosis & therapy of the process of medication. The quality of medical device projects direct influence on the users. The inferior quality of medical device affects the safety of consumers, even threatens the life. The consequence can be fatal. As the consequence of technological advancement, the varieties & functions of medical device are becoming more and more sophisticated. The utilization ratio increases, too. Without strict control in the process of production, the medical device will create permanent injuries.
The ultimate goal of manufacturing medical device is for clinical application in diagnosis & therapy for human body’s health. However, the success of medical device’s development merely represents 1/3 of R&D. The subsequent clinical investigation & validation and the monitor & correction during post-market are the most important port in the overall research and development of medical devices.
Pursuant to the regulation of Federal Register of U.S., the Food and Drug Administration (FDA) announced the enforcement of medical device GMP in 1978. Since then, all medical devices market into the United Stated are required to comply with the GMP requirements. The Department of Health (DOH) and the Ministry of Economic Affairs (MOEA) announced “Notice for Execution of Medical Device GMP” on August 10, 1998, effective from February 10, 1999.
The Medical Device GMP signifies our country’s medical device management system’s movement toward global harmonization with International Standard ISO 13485: 1996 which was initiated based on FDA’s experience of current GMP inspection. Now ISO 9001/2 have become the minimum requirements of quality for all industries. On the other hand, the Medical Device GMP is a regulation initiated specifically for local and foreign manufacturers who market medical devices into R.O.C.
The utilization of medical device affects patient’s lives directly. Therefore, the requirements for quality and safety are much higher than other industrial products. The specific requirements for the safety and functions of medical devices have reconciled the administration systems and products inspections of the United Stated and European countries. Now, the inspection of medical device entails product life-cycle management, including all phases of R&D, production, utilization and recycling.
This research project is made with the hope that the quality of medical device and the clinical application can be warranted in line with the Medical Device GMP announced by government, thus provides the quality-assured medical services to the general public.
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