我国医疗器械临床试验监管现状分析及对策探讨.docxVIP

PGE \* MERGEFORMT PGE \* MERGEFORMT 1 我国医疗器械临床试验监管现状分析及对策探讨 bstrct: In clinicl trils of medicl devices is n importnt prt of the mngement of medicl devices. The one hnd, through clinicl trils, so get resonble ssessment of the sfety nd efficcy of medicl devices, nd provide the scientific bsis for medicl devices listed. On the other hnd, clinicl trils re time consuming, cost lot. If not properly mnged, my increse socil costs, hevy finncil burden to the producers nd even consumers, thereby ffecting the development of the medicl device industry. This pper nlyzes Chins medicl device clin