医疗器械临床试验需要符合哪些要求？

test4

　　众所周知，国家对医疗器械按照风险程度实行分类管理，第一类医疗器械实行产品备案管理，第二类、第三类医疗器械实行产品注册管理。根据医疗器械注册管理办法的相关规定，办理第一类医疗器械备案，不需进行临床试验，而申请第二类、第三类医疗器械注册，则应当进行临床试验。不过，进行医疗器械临床试验需要符合下列要求：

　　一、申请第二类、第三类医疗器械注册，需要按照医疗器械临床试验质量管理规范的要求，在取得资质的临床试验机构内进行医疗器械临床试验，临床试验样品的生产必须符合医疗器械质量管理体系的相关要求，而且提交的临床评价资料必须包括临床试验方案和临床试验报告。

　　二、由于有些第三类医疗器械进行临床试验对人体具有较高风险的，所以这些医疗器械需要经国家食品药品监督管理总局批准后才能进行临床试验。而且需进行临床试验审批的第三类医疗器械目录由国家食品药品监督管理总局制定、调整并公布。

　　三、对于需进行医疗器械临床试验审批的，申请人应当按照相关要求向国家食品药品监督管理总局报送申报资料。

　　四、在国家食品药品监督管理总局将申报资料转交医疗器械技术审评机构技术审评过程中，需要申请人补正资料的，申请人必须在一年内按照补正通知的要求一次提供补充资料，逾期未提交补充资料的将被终止技术审评，不予批准。

　　五、临床试验申报资料虚假或已有最新研究证实原批准的临床试验伦理性和科学性存在问题的，将会被撤销已获得的医疗器械临床试验批准文件。

　　六、医疗器械临床试验应当在批准后三年内实施，逾期未实施的，原批准文件自行废止，如果仍需进行临床试验的，则需要重新申请。

khbfs

快速办理正规票增值税,「保真→#联#系#《15040371013》小陈

爱上的局面kd

做做看哦，谢谢提供













模拟试题
银行从业资格考试成绩有效期
会计
章节习题
经济师合格分数线
考试教材
基金从业考试
中级经济师网上报名
注册会计师合格标准
期货基础知识考试题库
批量练习试题
一级建造师市政工程
证券从业资格考试
2019一级建造师准考证打印
初级会计职称官网报名系统
二级建造师建筑工程试卷
中级经济师试题软件
章节练习
证券从业资格考试真题
银行从业资格考试报名时间

oiokd

这个还不错,好帖子，大家谈谈

oiokd

http://www.sun989.com/thread-783239-1-1.html
http://www.sun989.com/thread-783238-1-1.html
http://www.sun989.com/thread-783237-1-1.html
http://www.sun989.com/thread-783236-1-1.html
http://www.sun989.com/thread-783235-1-1.html
http://www.sun989.com/thread-783234-1-1.html
http://www.sun989.com/thread-783233-1-1.html
http://www.sun989.com/thread-783232-1-1.html
http://www.sun989.com/thread-783231-1-1.html
http://www.sun989.com/thread-783230-1-1.html
http://www.sun989.com/thread-783229-1-1.html
http://www.sun989.com/thread-783228-1-1.html
http://www.sun989.com/thread-783227-1-1.html
http://www.sun989.com/thread-783226-1-1.html
http://www.sun989.com/thread-783225-1-1.html
http://www.sun989.com/thread-783224-1-1.html
http://www.sun989.com/thread-783223-1-1.html
http://www.sun989.com/thread-783221-1-1.html
http://www.sun989.com/thread-783220-1-1.html
http://www.sun989.com/thread-783219-1-1.html
http://www.sun989.com/thread-783218-1-1.html
http://www.sun989.com/thread-783217-1-1.html
http://www.sun989.com/thread-783216-1-1.html
http://www.sun989.com/thread-783215-1-1.html
http://www.sun989.com/thread-783214-1-1.html
http://www.sun989.com/thread-783213-1-1.html
http://www.sun989.com/thread-783212-1-1.html
http://www.sun989.com/thread-783211-1-1.html
http://www.sun989.com/thread-783210-1-1.html
http://www.sun989.com/thread-783209-1-1.html
http://www.sun989.com/thread-783148-1-1.html
http://www.sun989.com/thread-783147-1-1.html
http://www.sun989.com/thread-783146-1-1.html
http://www.sun989.com/thread-783145-1-1.html
http://www.sun989.com/thread-783144-1-1.html
http://www.sun989.com/thread-783143-1-1.html
http://www.sun989.com/thread-783142-1-1.html
http://www.sun989.com/thread-783141-1-1.html
http://www.sun989.com/thread-783139-1-1.html
http://www.sun989.com/thread-783138-1-1.html
http://www.sun989.com/thread-783137-1-1.html
http://www.sun989.com/thread-783136-1-1.html
http://www.sun989.com/thread-783135-1-1.html
http://www.sun989.com/thread-783134-1-1.html
http://www.sun989.com/thread-783133-1-1.html
http://www.sun989.com/thread-783132-1-1.html
http://www.sun989.com/thread-783131-1-1.html
http://www.sun989.com/thread-783130-1-1.html
http://www.sun989.com/thread-783129-1-1.html
http://www.sun989.com/thread-783128-1-1.html

o拼多多券商城k

▇骗贩子团队
骗子QQ723323134,骗子微信kkk111223
845725254
67537346
1336510365
820112280
723323134
505761913
微信 k91551
464250413
766481639
547625716
582668028
770037091

拼多多优惠券商城 全场都有券

免拼团 一个也拼的拼多多

自己搜索好货

电脑端入口http://www.wz10086.top保存下图手机版入口二维码防走丢

www.pinduoduo10086.xyz
www.sihu45.online
www.weixinqun.online
www.youhuiquan.我爱你

www.youhuiquan.xn--6qq986b3xl

gvgwe

http://www.longyin.net/thread-3798749-1-1.html
http://www.longyin.net/thread-3798748-1-1.html
http://www.longyin.net/thread-3798747-1-1.html
http://www.longyin.net/thread-3798746-1-1.html
http://www.longyin.net/thread-3798745-1-1.html
http://www.longyin.net/thread-3798744-1-1.html
http://www.longyin.net/thread-3798743-1-1.html
http://www.longyin.net/thread-3798742-1-1.html
http://www.longyin.net/thread-3798741-1-1.html
http://www.longyin.net/thread-3798740-1-1.html
http://www.longyin.net/thread-3798739-1-1.html
http://www.longyin.net/thread-3798738-1-1.html
http://www.longyin.net/thread-3798737-1-1.html
http://www.longyin.net/thread-3798736-1-1.html
http://www.longyin.net/thread-3798735-1-1.html
http://www.longyin.net/thread-3798734-1-1.html
http://www.longyin.net/thread-3798733-1-1.html
http://www.longyin.net/thread-3798732-1-1.html
http://www.longyin.net/thread-3798731-1-1.html
http://www.longyin.net/thread-3798728-1-1.html
http://www.longyin.net/thread-3798726-1-1.html
http://www.longyin.net/thread-3798725-1-1.html
http://www.longyin.net/thread-3798724-1-1.html
http://www.longyin.net/thread-3798723-1-1.html
http://www.longyin.net/thread-3798722-1-1.html
http://www.longyin.net/thread-3798721-1-1.html
http://www.longyin.net/thread-3798720-1-1.html
http://www.longyin.net/thread-3798719-1-1.html
http://www.longyin.net/thread-3798718-1-1.html
http://www.longyin.net/thread-3798717-1-1.html
http://www.longyin.net/thread-3798716-1-1.html
http://www.longyin.net/thread-3798715-1-1.html
http://www.longyin.net/thread-3798714-1-1.html
http://www.longyin.net/thread-3798713-1-1.html
http://www.longyin.net/thread-3798712-1-1.html
http://www.longyin.net/thread-3798711-1-1.html
http://www.longyin.net/thread-3798710-1-1.html
http://www.longyin.net/thread-3798709-1-1.html
http://www.longyin.net/thread-3798707-1-1.html
http://www.longyin.net/thread-3798705-1-1.html
http://www.longyin.net/thread-3798704-1-2.html
http://www.longyin.net/thread-3798703-1-2.html
http://www.longyin.net/thread-3798701-1-2.html
http://www.longyin.net/thread-3798699-1-2.html
http://www.longyin.net/thread-3798697-1-2.html
http://www.longyin.net/thread-3798695-1-2.html
http://www.longyin.net/thread-3798693-1-2.html
http://www.longyin.net/thread-3798691-1-2.html
http://www.longyin.net/thread-3798689-1-2.html
http://www.longyin.net/thread-3798687-1-2.html
http://www.longyin.net/thread-3798685-1-2.html
http://www.longyin.net/thread-3798683-1-2.html
http://www.longyin.net/thread-3798681-1-2.html
http://www.longyin.net/thread-3798678-1-2.html
http://www.longyin.net/thread-3798676-1-2.html
http://www.longyin.net/thread-3798674-1-2.html
http://www.longyin.net/thread-3798672-1-2.html
http://www.longyin.net/thread-3798670-1-2.html
http://www.longyin.net/thread-3798668-1-2.html
http://www.longyin.net/thread-3798666-1-2.html
http://www.longyin.net/thread-3798664-1-2.html
http://www.longyin.net/thread-3798662-1-2.html
http://www.longyin.net/thread-3798660-1-2.html
http://www.longyin.net/thread-3798658-1-2.html
http://www.longyin.net/thread-3798656-1-2.html
http://www.longyin.net/thread-3798654-1-2.html
http://www.longyin.net/thread-3798652-1-2.html
http://www.longyin.net/thread-3798650-1-2.html
http://www.longyin.net/thread-3798647-1-2.html
http://www.longyin.net/thread-3798645-1-2.html
http://www.longyin.net/thread-3798643-1-2.html
http://www.longyin.net/thread-3798641-1-2.html
http://www.longyin.net/thread-3798638-1-2.html
http://www.longyin.net/thread-3798636-1-2.html
http://www.longyin.net/thread-3798634-1-2.html
http://www.longyin.net/thread-3798632-1-2.html
http://www.longyin.net/thread-3798630-1-2.html
http://www.longyin.net/thread-3798628-1-2.html
http://www.longyin.net/thread-3798626-1-2.html
http://www.longyin.net/thread-3798624-1-2.html
http://www.longyin.net/thread-3798622-1-3.html
http://www.longyin.net/thread-3798620-1-3.html
http://www.longyin.net/thread-3798618-1-3.html
http://www.longyin.net/thread-3798616-1-3.html
http://www.longyin.net/thread-3798614-1-3.html
http://www.longyin.net/thread-3798612-1-3.html
http://www.longyin.net/thread-3798610-1-3.html
http://www.longyin.net/thread-3798608-1-3.html
http://www.longyin.net/thread-3798606-1-3.html
http://www.longyin.net/thread-3798603-1-3.html
http://www.longyin.net/thread-3798601-1-3.html
http://www.longyin.net/thread-3798599-1-3.html
http://www.longyin.net/thread-3798597-1-3.html
http://www.longyin.net/thread-3798595-1-3.html
http://www.longyin.net/thread-3798593-1-3.html
http://www.longyin.net/thread-3798591-1-3.html
http://www.longyin.net/thread-3798589-1-3.html
http://www.longyin.net/thread-3798587-1-3.html
http://www.longyin.net/thread-3798585-1-3.html
http://www.longyin.net/thread-3798583-1-3.html
http://www.longyin.net/thread-3798581-1-3.html
http://www.longyin.net/thread-3798578-1-3.html
http://www.longyin.net/thread-3798576-1-3.html
http://www.longyin.net/thread-3798574-1-3.html
http://www.longyin.net/thread-3798572-1-3.html
http://www.longyin.net/thread-3798570-1-3.html
http://www.longyin.net/thread-3798568-1-3.html
http://www.longyin.net/thread-3798566-1-3.html
http://www.longyin.net/thread-3798564-1-3.html
http://www.longyin.net/thread-3798562-1-3.html
http://www.longyin.net/thread-3798560-1-3.html
http://www.longyin.net/thread-3798558-1-3.html
http://www.longyin.net/thread-3798556-1-3.html
http://www.longyin.net/thread-3798554-1-3.html
http://www.longyin.net/thread-3798552-1-3.html
http://www.longyin.net/thread-3798550-1-3.html
http://www.longyin.net/thread-3798548-1-3.html
http://www.longyin.net/thread-3798546-1-3.html
http://www.longyin.net/thread-3798544-1-3.html
http://www.longyin.net/thread-3798542-1-3.html
http://www.longyin.net/thread-3798540-1-4.html
http://www.longyin.net/thread-3798538-1-4.html
http://www.longyin.net/thread-3798536-1-4.html
http://www.longyin.net/thread-3798534-1-4.html
http://www.longyin.net/thread-3798532-1-4.html
http://www.longyin.net/thread-3798530-1-4.html
http://www.longyin.net/thread-3798528-1-4.html
http://www.longyin.net/thread-3798526-1-4.html
http://www.longyin.net/thread-3798524-1-4.html
http://www.longyin.net/thread-3798522-1-4.html
http://www.longyin.net/thread-3798520-1-4.html
http://www.longyin.net/thread-3798518-1-4.html
http://www.longyin.net/thread-3798515-1-4.html
http://www.longyin.net/thread-3798513-1-4.html
http://www.longyin.net/thread-3798511-1-4.html
http://www.longyin.net/thread-3798509-1-4.html
http://www.longyin.net/thread-3798507-1-4.html
http://www.longyin.net/thread-3798505-1-4.html
http://www.longyin.net/thread-3798503-1-4.html
http://www.longyin.net/thread-3798501-1-4.html
http://www.longyin.net/thread-3798500-1-4.html
http://www.longyin.net/thread-3798499-1-4.html
http://www.longyin.net/thread-3798498-1-4.html
http://www.longyin.net/thread-3798497-1-4.html
http://www.longyin.net/thread-3798496-1-4.html
http://www.longyin.net/thread-3798495-1-4.html
http://www.longyin.net/thread-3798494-1-4.html
http://www.longyin.net/thread-3798409-1-4.html
http://www.longyin.net/thread-3798408-1-4.html
http://www.longyin.net/thread-3798407-1-4.html
http://www.longyin.net/thread-3798406-1-4.html
http://www.longyin.net/thread-3798405-1-4.html
http://www.longyin.net/thread-3798404-1-4.html
http://www.longyin.net/thread-3798403-1-4.html
http://www.longyin.net/thread-3798402-1-4.html
http://www.longyin.net/thread-3798401-1-4.html
http://www.longyin.net/thread-3798400-1-4.html
http://www.longyin.net/thread-3798399-1-4.html
http://www.longyin.net/thread-3798398-1-4.html
http://www.longyin.net/thread-3798397-1-4.html

vvsqw

哪 里 有乙 o 醚 三 唑 仑 买 ▇★加【文老板QQ86450585灵药世家】诚信经营▇、恪守信誉”的核心价值观,为客户提供多样、安全、稳定、放心的产品。

香港社区网

我喜欢，请大家鼓掌支持，谢谢

香港社区网

以后真的注意了。。。 楼主真好

澳门生活网b

不错,顶的人不多啊，快点继续













第五代QQ机器人、QQ群机器人、论坛QQ机器人、智能客服机器人、QQplus机器人、QQ群互联机器人..联系QQ4000017854