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The State Council approved the "(Revised Draft) Supervision and Regulation of Medical Devices"
February 12, 2014 , "Medical Devices Regulations ( Amendment Bill ) " by the State Council executive meeting , to be promulgated to implement .
The current situation , " Medical Devices Regulations " promulgated in 2000 , ten years, with the development and changes in China's medical equipment industry , which is not suitable for industrial development to highlight the new changes , the industry's request to amend a strong voice . In 2006 , former State Food and Drug Administration to start the revision , has organized dozens of research , listen to opinions from all sides , carefully studied , modified, in March 2008 submitted to the State Council Legislative Affairs Office of the manuscript . Subsequently , actively cooperate with the State Council Legislative Affairs Office , repeated studies, coordination , demonstration, modify , forming a " ( Revised Draft ) Medical Devices Regulations ."
" Bill (Amendment Bill ) ," the original " Bill " made a comprehensive revision of eighty eight chapters , eight chapters forty-eight than the original "Regulations" compared to the main content changes include: adjusting the definition of medical devices and classification rules ; further improve the product registration, production, operating authority for approval or for the record ; additional measures for monitoring the quality of the medical device production processes and risk monitoring ; new medical device adverse event monitoring , traceability and recall systems ; further strengthen sales cycle accounting, inspection and acceptance system and cable card obligations ; added with the relevant provisions in the regulation of medical devices ; increase the intensity of punishment and other violations .
" Bill ( Amendment Bill ) ," the smooth passage for comprehensively promoting administration according to law , improve food and drug regulatory legal system to ensure that medical devices are safe, effective , safeguard human health and safety , to achieve positive interaction of governance and social self-regulation has an important significance.