| Summary: | 碩士 === 東吳大學 === 法律學系 === 105 === Medical device manufacture management system also contains risk management, not only it related to safety and health issue directly related to the end users, but it also affects to the government effectiveness, and the manufacture of medical device, and import and export regulations. At the end, it will affect end users’ chance to use the most advanced medical device.
From the thorough study of Taiwan Pharmaceutical Affair Act and after a complete analysis, we have gathered current government regulations, to see Taiwan’s medical device manufacture management system structure and how it works. At the same time, we have analyzed medical device management system that covers risk identification, risk assessment and risk management.
This study is based on the draft of Taiwan Medical Device Regulations Act, and we compare and analyze with US FDA, JAPL and CFDA regulations. And at the same time, we also compare the current Taiwan Pharmaceutical Affair Act with the draft of Taiwan Medical Device Regulations Act to see if there is any advantage or not.
After the analysis, the study shows that we should speed up the process of medical device registration in order to faster the product into the market. Especially to those products that are at low risk. That means faster the process of registration, at the same time, it will also increase the effectiveness of the government working process. The draft of Taiwan medical device regulation even though at this time, it has some point where is not clear yet, but we still can use other country’s regulations as reference to make our medical device regulations more suitable to the manufacture environment and also to the government effectiveness, and hopefully make a health life for whole mankind.
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