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国家药监局关于发布球囊扩张导管等6项指导原则的通告(2020年 第62号)

2020-10-02 CDE CDE

球囊扩张导管指导原则
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国家药监局关于发布球囊扩张导管等6项指导原则的通告(2020年 第62号)

国家药监局关于发布球囊扩张导管等6项指导原则的通告(2020年 第62号)

为加强医疗器械产品注册工作的监督和指导，进一步提高注册审查质量，国家药品监督管理局组织制定了《球囊扩张导管注册技术审查指导原则》《输注产品针刺伤防护装置要求与评价技术审查指导原则》《生物型股骨柄柄部疲劳性能评价指导原则》《同种异体植入性医疗器械病毒灭活工艺验证指导原则（2020年修订版）》《3D打印患者匹配下颌骨假体注册审查指导原则》《个性化匹配骨植入物及工具医工交互质控审查指导原则》，现予发布。
　　特此通告。

附件：1.球囊扩张导管注册技术审查指导原则

　　　　　2.输注产品针刺伤防护装置要求与评价技术审查指导原则

　　　　　3.生物型股骨柄柄部疲劳性能评价指导原则

　　　　　4.同种异体植入性医疗器械病毒灭活工艺验证指导原则（2020年修订版）

　　　　　5.3D打印患者匹配下颌骨假体注册审查指导原则

　　　　　6.个性化匹配骨植入物及工具医工交互质控审查指导原则

 

国家药监局
2020年9月17日

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1688442, encodeId=26ba168844282, content=<a href='/topic/show?id=360f686434a' target=_blank style='color:#2F92EE;'>#球囊扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68643, encryptionId=360f686434a, topicName=球囊扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=401d28589001, createdName=1249898am24暂无昵称, createdTime=Thu Apr 01 02:37:33 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752738, encodeId=5b6a1e527385a, content=<a href='/topic/show?id=13016864602' target=_blank style='color:#2F92EE;'>#球囊扩张导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68646, encryptionId=13016864602, topicName=球囊扩张导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d62936562906, createdName=jwf_2013, createdTime=Thu Apr 29 22:37:33 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684848, encodeId=557e168484890, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Sat May 08 17:37:33 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301720, encodeId=bcac1301e20ee, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384424, encodeId=3668138442405, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429260, encodeId=e50c1429260dd, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=)]
    2021-04-01 1249898am24暂无昵称

    #球囊扩张#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1688442, encodeId=26ba168844282, content=<a href='/topic/show?id=360f686434a' target=_blank style='color:#2F92EE;'>#球囊扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68643, encryptionId=360f686434a, topicName=球囊扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=401d28589001, createdName=1249898am24暂无昵称, createdTime=Thu Apr 01 02:37:33 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752738, encodeId=5b6a1e527385a, content=<a href='/topic/show?id=13016864602' target=_blank style='color:#2F92EE;'>#球囊扩张导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68646, encryptionId=13016864602, topicName=球囊扩张导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d62936562906, createdName=jwf_2013, createdTime=Thu Apr 29 22:37:33 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684848, encodeId=557e168484890, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Sat May 08 17:37:33 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301720, encodeId=bcac1301e20ee, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384424, encodeId=3668138442405, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429260, encodeId=e50c1429260dd, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=)]
    2021-04-29 jwf_2013

    #球囊扩张导管#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1688442, encodeId=26ba168844282, content=<a href='/topic/show?id=360f686434a' target=_blank style='color:#2F92EE;'>#球囊扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68643, encryptionId=360f686434a, topicName=球囊扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=401d28589001, createdName=1249898am24暂无昵称, createdTime=Thu Apr 01 02:37:33 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752738, encodeId=5b6a1e527385a, content=<a href='/topic/show?id=13016864602' target=_blank style='color:#2F92EE;'>#球囊扩张导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68646, encryptionId=13016864602, topicName=球囊扩张导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d62936562906, createdName=jwf_2013, createdTime=Thu Apr 29 22:37:33 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684848, encodeId=557e168484890, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Sat May 08 17:37:33 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301720, encodeId=bcac1301e20ee, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384424, encodeId=3668138442405, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429260, encodeId=e50c1429260dd, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=)]
    2021-05-08 lsj637

    #扩张#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1688442, encodeId=26ba168844282, content=<a href='/topic/show?id=360f686434a' target=_blank style='color:#2F92EE;'>#球囊扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68643, encryptionId=360f686434a, topicName=球囊扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=401d28589001, createdName=1249898am24暂无昵称, createdTime=Thu Apr 01 02:37:33 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752738, encodeId=5b6a1e527385a, content=<a href='/topic/show?id=13016864602' target=_blank style='color:#2F92EE;'>#球囊扩张导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68646, encryptionId=13016864602, topicName=球囊扩张导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d62936562906, createdName=jwf_2013, createdTime=Thu Apr 29 22:37:33 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684848, encodeId=557e168484890, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Sat May 08 17:37:33 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301720, encodeId=bcac1301e20ee, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384424, encodeId=3668138442405, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429260, encodeId=e50c1429260dd, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=)]
    2020-10-04 xuyu

    #药监局#

    0

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    2020-10-04 花花1366

    #球囊#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1688442, encodeId=26ba168844282, content=<a href='/topic/show?id=360f686434a' target=_blank style='color:#2F92EE;'>#球囊扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68643, encryptionId=360f686434a, topicName=球囊扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=401d28589001, createdName=1249898am24暂无昵称, createdTime=Thu Apr 01 02:37:33 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752738, encodeId=5b6a1e527385a, content=<a href='/topic/show?id=13016864602' target=_blank style='color:#2F92EE;'>#球囊扩张导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68646, encryptionId=13016864602, topicName=球囊扩张导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d62936562906, createdName=jwf_2013, createdTime=Thu Apr 29 22:37:33 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684848, encodeId=557e168484890, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Sat May 08 17:37:33 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301720, encodeId=bcac1301e20ee, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384424, encodeId=3668138442405, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429260, encodeId=e50c1429260dd, content=<a href='/topic/show?id=321a409e058' target=_blank style='color:#2F92EE;'>#国家药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40970, encryptionId=321a409e058, topicName=国家药监局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b1e4178198, createdName=pyaili, createdTime=Sun Oct 04 06:37:33 CST 2020, time=2020-10-04, status=1, ipAttribution=)]
    2020-10-04 pyaili

    #国家药监局#

    0

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