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- W2436183182 abstract "Objective: To analyze the status, problems and reasons of medical device registration testing in China, in order to provide references for scientific supervision, improve the level and efficiency of medical device testing and promote the development of medical device industry in China on the basis of guaranteeing the safe use of medical devices. Methods: Combined insider interviews, literature review with field research. Firstly, we summarized the status of medical device registration testing in China through literature review, and preliminary analyzed its problems and causes. Secondly, we probed deeply into its problems and causes through insider interviews and field research, based on which suggestions would be offered for supervisory authorities to refer to. Results: The problems of medical device testing in China were deficient focus on high-risk factors, prolonged testing time and poor sample representation, due to unscientific supervision, excessive products in the class II and class III, imperfect testing standards, huge technical difficulties in testing and insufficient continuous supervision after the practice of good manufacturer and the marketing of the medical devices. Conclusions: To improve the level and efficiency of medical device registration testing, we should change the regulatory mentality, accelerate the constructions of medical device regulations and standards, distribute the testing power rationally and enhance continuous supervision during the whole process from GMP to products recalls." @default.
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- W2436183182 date "2013-01-01" @default.
- W2436183182 modified "2023-10-15" @default.
- W2436183182 title "The Status of Medical Device Registration Testing in China" @default.
- W2436183182 doi "https://doi.org/10.1007/978-3-642-29305-4_447" @default.
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