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Chang-Hong Whitney10.21.06
Medical device supervision and surveillance are new to China and the SFDA, but the SFDA’s determination to strengthen management in this area bolsters the idea that the agency is taking its watchdog role more seriously. As such, manufacturers and distribution companies need to examine their internal management system, install qualified personnel in quality and regulatory positions as well as stay informed of what is coming from the SFDA pipeline to stay on top of greater regulatory requirements.