富翁彩票在线

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                400-609-1580
                病人监护仪产品,增加新的功能参数,变更注册时是否需要进行临床试验?

                  1.如果新增的功能参数与“免于进行临床试验目录”产品具有等同性,则可按照临床评价相关要求予以评价。

                  2.如果新增的功能参数的病人监护仪具有同品种医疗器械,可◥采取临床评价的方式予以评价。若新增功能参数的境外数据符合“接受医疗器械境外临床试验数据技术指导原则”,可提供相关临床资料。

                  3.如果新增功能参数的病ㄨ人监护仪无法通过上述方式进行临床评价,应考虑进行临床试验,以确认产品使用范围。

                  审评一部供稿↓

                  2018-09-29 14:00