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医疗器械作为关系到生命的仪器，在各国都受到极其严格的监管。很多优秀的医疗器械由于安全性等原因，无法通过监管部门的审核，最终无法用于拯救生命。而美国的FDA以其严苛的审核条例令很多中国医疗器械厂商望而却步。
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