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无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则(2019年第70号)

FABUSHIJIAN:2022-03-02  LIULAN:CI

国家药监局关于发布无源植入性骨、关节及口腔硬组织个性化增材制造<a href=/medical/ target=_blank class=infotextkey>医疗器械注册</a>技术审查指导原则的通告(2019年第70号)

国家药监局关于发布无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则的通告(2019年第70号)


FABUSHIJIAN:2020-10-15

  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《无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则》,现予发布。
  特此通告。

  附件:

国家药监局
2019年9月23日

无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则
(2019年第70号)

  WEILEGENGHAODITUIDONGHEGUIFANGEXINGHUAZENGCAIZHIZAOYILIAOQIXIEDECHUANGXINFAZHAN,ZHIDAOSHENQINGRENJINXINGGEXINGHUAZENGCAIZHIZAOYILIAOQIXIECHANPINDEZHUCESHENBAO,TONGSHIYEWEIYILIAOQIXIEJIANDUGUANLIBUMENDUIZHUCESHENBAOZILIAODESHENPINGTIGONGJISHUCANKAO,TEZHIDINGBENZHIDAOYUANZE。

  BENZHIDAOYUANZESHIDUIWUYUANZHIRUXINGGU、GUANJIEJIKOUQIANGYINGZUZHIGEXINGHUAZENGCAIZHIZAOYILIAOQIXIECHANPINZHUCESHENBAOZILIAODEYIBANYAOQIU。SHENQINGRENYINGDANGGENJUCHANPINDETEXINGQUEDINGBENZHIDAOYUANZEGEXIANGYAOQIUDESHIYONGXING,BINGYIJUCHANPINDETEXINGDUIZHUCESHENBAOZILIAODENEIRONGJINXINGCHONGSHIHEXIHUA。

  BENZHIDAOYUANZESHIDUISHENQINGRENHESHENCHARENYUANDEZHIDAOXINGWENJIAN,DANBUBAOKUOZHUCESHENPISUOSHEJIDEXINGZHENGSHIXIANG,YIBUZUOWEIFAGUIQIANGZHIZHIXING。RUGUOYOUNENGGOUMANZUXIANGGUANFAGUIYAOQIUDEQITAFANGFA,YEKEYICAIYONG,DANSHIXUYAOTIGONGXIANGXIDEYANJIUZILIAOHEYANZHENGZILIAO。YINGDANGZAIZUNXUNXIANGGUANFAGUIHEBIAOZHUNDEQIANTIXIASHIYONGBENZHIDAOYUANZE。

  BENZHIDAOYUANZESHIZAIDUIXIANXINGFAGUI、BIAOZHUNTIXI,YIJIDANGQIANGEXINGHUAZENGCAIZHIZAOYILIAOQIXIEJISHUHEGUANLIKEXUERENZHISHUIPINGXIAZHIDING。SUIZHEFAGUIHEBIAOZHUNDEBUDUANWANSHAN,YIJIJISHUHEJIANGUANKEXUEDEBUDUANFAZHAN,JIANGUANBUMENJIANGDUIBENZHIDAOYUANZEDENEIRONGJINXINGGENGXINHEXIUDING。

  一、适用范围

  (YI)BENZHIDAOYUANZESHIYONGYUKEYISHIXINGZHUCEGUANLIDEGEXINGHUAZENGCAIZHIZAOYILIAOQIXIE,YINGDANGTONGSHIMANZUYIXIAYAOSU:

  1.SHIYONGYUGU、GUANJIE、KOUQIANGYINGZUZHIWUYUANZHIRUXINGYILIAOQIXIE;

  2.GEXINGHUASHEJISHIYONGYUTESHUBINGSUNQINGKUANGHE/HUOSHIPEITESHUJIEPOUJIEGOU;

  3.QUANBUHUOBUFENTONGGUOZENGCAIZHIZAOJIAGONGGONGYISHIXIAN。

  (ER)SHUYU“DINGZHISHIYILIAOQIXIE”DEQINGXING,YINGDANGANZHAO《DINGZHISHIYILIAOQIXIEJIANDUGUANLIGUIDING(SHIXING)》YAOQIUGUANLI。

  (SAN)SHUYUXIALIERENHEYIXIANGDE,YOUYUWEIHANGAISUOYOUFENGXIAN,JINKEBUFENCANKAOBENZHIDAOYUANZEDEYAOQIU:

  1.SHIYONGYUCHUGU、GUANJIE、KOUQIANGYINGZUZHIWAIDEQITAYILIAOQIXIE;

  2.MANZU“GEXINGHUASHEJI”HE/HUO“ZENGCAIZHIZAOJIAGONGGONGYI”,DANBUMANZU

  “WUYUANZHIRUXING”DEYILIAOQIXIE;

  3.HANYOUYAOWUCHENGFEN、XIBAO、ZUZHIDENGSHENGWUHUOXINGWUZHIDESHENGWU3DDA

  YINDENGTESHUSHEJIDEYILIAOQIXIE。

  二、技术审查要点

  (YI)CHANPINMINGCHENG

  YINGDANGFUHE《YILIAOQIXIETONGYONGMINGCHENGMINGMINGGUIZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI19HAO)XIANGGUANYAOQIU。

  (ER)CHANPINJIEGOUYUZUCHENG

  MIAOSHUCHANPINGEZUCHENGBUFENCAILIAODEHUAXUECHENGFENJIBILI。RUSHIYONG,YINGDANGMINGQUECHANPINHUAXUEMINGCHENG、PAIHAOJIFUHEBIAOZHUN。

  MIAOSHUCHANPINJIEGOUZUCHENG、JIEGOUTEZHENGBINGLUNZHENGJIEGOU、XINGTAISHEJIDEHELIXING。TIGONGTUSHISHUOMINGMIAOSHUCHANPINYURENTIJIECHUBUWEIDEJIEMIANJIEGOUHELIANJIEFANGSHI。

  (SAN)XINGHAOGUIGE

  MIAOSHUCHANPINGEXINGHAODEGUANJIANCHICUNCANSHU(FANWEI)HEYUNCHA。MINGQUEXINGHAOGUIGEDEHUAFENYUANZE。

  (SI)CHANPINGONGZUOYUANLI/ZUOYONGJILI

  RUSHIYONG,MIAOSHUCHANPINGONGZUOYUANLI/ZUOYONGJILI。

  (WU)ZHUCEDANYUANHUAFENYUANZEHESHILI

  SHENBAOCHANPINZHUYAOZUCHENGBUFENDEZENGCAIZHIZAOCAILIAO、GONGYI、GUANJIANXINGNENGZHIBIAO、SHIYONGFANWEIBUTONGDECHANPINYINGDANGHUAFENWEIBUTONGDEZHUCEDANYUAN。QITAQINGXINGKECANKAO《YILIAOQIXIEZHUCEDANYUANHUAFENZHIDAOYUANZE》HEQITAJISHUSHENCHAZHIDAOYUANZEDEXIANGGUANYAOQIU。

  (LIU)CHANPINSHIYONGDEXIANGGUANBIAOZHUN

  BAOKUODANBUJINXIANYUBIAO1SUOLIECHUDEXIANGGUANBIAOZHUN(ZHU:BENZHIDAOYUANZEZHONGBIAOZHUNSHIYONGZUIXINBANBEN,XIATONG)。

表1 相关产品标准

标准编号 标准名称
YY/T 0316-2016 《医疗器械 风险管理对医疗器械的应用》
ISO 17296-2:2015 Additive manufacturing -- General principles -- Part 2: Overview of process categories and feedstock
ISO 17296-3:2014 Additive manufacturing -- General principles -- Part 3: Main characteristics and corresponding test methods
ISO 17296-4:2014 Additive manufacturing -- General principles -- Part 4: Overview of data processing
ASTM F2924-12 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4Vanadium ELI(Extra Low Interstitial)with Powder Bed Fusion
ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
ASTM F3049-14 Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes
ISO/ASTM 52921:2013 Standard terminology for additive manufacturing -- Coordinate systems and test methodologies
ISO/ASTM 52915:2016 Specification for additive manufacturing file format(AMF)Version 1.2
ISO/ASTM 52901:2017 Additive manufacturing -- General principles -- Requirements for purchased AM parts
ISO/ASTM 52900:2015 Additive manufacturing -- General principles – Terminology
 

  (QI)CHANPINSHIYONGFANWEI/YUQIYONGTU

  MIAOSHUCHANPINJUTIDESHIYONGBUWEI、SHIYONGRENQUN、SHIYONGQINGXING、SHIYINGZHENGHEJINJIZHENG、YUQISHIYONGHUANJING。MINGQUECAOZUOGAICHANPINYINGDANGJUBEIDEJINENG/ZHISHI/PEIXUN。SHUOMINGYUQIYUSHENBAOCHANPINPEIHESHIYONGDEYILIAOQIXIEDEXINGHAOGUIGE。

  (BA)CHANPINFENGXIANFENXIZILIAO

  GENJUYY/T 0316-2016《YILIAOQIXIE FENGXIANGUANLIDUIYILIAOQIXIEDEYINGYONG》,CHONGFENSHIBIECHANPINDEGEXINGHUASHEJI、YUANCAILIAOCAIGOU、SHENGCHANJIAGONGGUOCHENG、CHANPINBAOZHUANG、MIEJUN、YUNSHU、ZHUCUN、SHIYONGDENGCHANPINSHENGMINGZHOUQINEIGEGEHUANJIEDEANQUANTEZHENG,CONGSHENGWUXUEWEIXIAN(YUAN)、HUANJINGWEIXIAN(YUAN)、YOUGUANSHIYONGDEWEIXIAN(YUAN)、GONGNENGSHIXIAO、NENGLIANGWEIXIAN(YUAN)(RUOSHEJI)、LAOHUAJICUNCHUBUDANGYINQIDEWEIXIAN(YUAN)DENGFANGMIAN,DUICHANPINJINXINGQUANMIANDEFENGXIANFENXI,BINGXIANGSHUSUOCAIQUDEFENGXIANKONGZHICUOSHI。

  TIGONGCHANPINSHANGSHIQIANDUIQIFENGXIANGUANLIHUODONGJINXINGQUANMIANPINGSHENSUOXINGCHENGDEFENGXIANGUANLIBAOGAO,CIBAOGAOZHIZAISHUOMINGBINGCHENGNUOFENGXIANGUANLIJIHUAYIBEIQIADANGDISHISHI,BINGJINGGUOYANZHENGHOUPANDINGZONGHESHENGYUFENGXIANSHIKEJIESHOUDE,YIYOUQIADANGDEFANGFAHUODECHANPINSHEJI、ZHIZAO、CHUCHANGHOULIUTONGHELINCHUANGYINGYONGDEXIANGGUANXINXI。

  FENGXIANGUANLIBAOGAOYINGDANGBAOKUOFENGXIANFENXI、FENGXIANPINGJIA、FENGXIANKONGZHIDENGCHANPINFENGXIANGUANLIDEXIANGGUANZILIAO,ZHISHAOYINGDANGBAOKUOCHANPINANQUANTEZHENGQINGDAN、CHANPINKEYUJIANDEWEIHAIJIWEIHAIFENXIQINGDAN(SHUOMINGWEIHAI、KEYUJIANSHIJIANXULIEJIWEIHAICHENGYINFENXI)、WEIHAICHUJINGHEKENENGFASHENGDESUNHAIZHIJIANDEGUANXI、FENGXIANPINGJIA、FENGXIANKONGZHICUOSHIYIJISHENGYUFENGXIANPINGJIAHUIZONGBIAO。

  (JIU)CHANPINDEYANJIUYAOQIU

  ZHISHAOYINGDANGBAOHANRUXIANEIRONG:

  1.CAILIAOBIAOZHENG

  JIEHECAILIAOSHUXINGHEGONGYILIUCHENG,FENBIEBIAOZHENGDAYINQIAN、DAYINHOUHEZHONGCHANPINCAILIAODEHUAXUECHENGFENHEZUCHENG、WEIGUANJIEGOU、LIXUEXINGNENGDENG,MINGQUEGEXIANGXINGNENGZHIBIAODEFUHEBIAOZHUN。

  2.CHANPINJIEGOUHEJIXIEXINGNENG

  BIAOZHENGCHANPINDEJIEGOU。LIRUCAIYONGTISHIXUEFANGFA、Micro-CTDENGBIAOZHENG3DDAYINDUOKONGJIEGOU,MINGQUEGUANJIANTEZHENGCANSHU,RUKONGDANYUANXINGTAI、KONGJINGDAXIAOJIQIFENBU、SIJING、KONGXILV、PINGJUNKONGXIJIEJU、KONGXIJIANBIANTIDU、NEIBULIANTONGXING、DUOKONGJIEGOUDEHOUDUDENG。

  GENJUYILIAOQIXIEDECAILIAOSHUXINGHEYUQIYONGTU,YINGDANGJINXINGCHANPINDONGJINGTAILIXUEXINGNENGCESHI,RUGANGDU、QUFUQIANGDU、JIXIANQIANGDU、RUBIAN/ZHANDANXING、PILAOHEMOSUNDENG。GEXINGHUAZENGCAIZHIZAOCHANPINKEYICAIYONGYUCHUANTONGZHIZAOGONGYICHANPINXIANGTONGDECESHIFANGFA,KEGENJUCHANPINSHIYONGDEXIANGGUANZHIDAOYUANZE、BIAOZHUNYAOQIUQUEDINGXUYAODEGONGNENGSHIYANXIANGMU、SHIYANFANGFA。

  YINGDANGSHIYONGDENGXIAOMOXINGJINXINGJIXIESHIYAN。DENGXIAOMOXINGYINGDANGYUSHENBAOCHANPINJINGGUOSUOYOUXIANGTONGDEDAYIN、DAYINHOUCHULI、QINGXI、MIEJUNDENGGONGYIBUZHOU,QIEMANZULINCHUANGYUQIDEJIEGOUHECHICUNYAOQIU。TIGONGDENGXIAOMOXINGQUEDINGDEHELIXINGLUNZHENG,RUSHIYONG3DJISUANJIMONI(RUYOUXIANYUANFENXI)DENGFANGFA。

  3.SHENGWUXIANGRONGXING

  SHENBAOCHANPINDESHENGWUXIANGRONGXINGPINGJIAYINGDANGANZHAOGB/T 16886.1—2011《YILIAOQIXIESHENGWUXUEPINGJIA DI1BUFEN:FENGXIANGUANLIGUOCHENGZHONGDEPINGJIAYUSHIYAN》ZHONGDEXITONGFANGFAKUANGTUJI《GUOJIASHIPINYAOPINJIANDUGUANLIJUGUANYUYINFAYILIAOQIXIESHENGWUXUEPINGJIAHESHENCHAZHINANDETONGZHI》(GUOSHIYAOJIANXIE〔2007〕345HAO)ZHONGDESHENCHAYAODIANJINXINGFENGXIANPINGJIA,ZAIQUEFAXIANGGUANSHUJUSHI,YINGDANGJINXINGBIYAODESHENGWUXIANGRONGXINGSHIYAN。

  4.QINGXIHEMIEJUN

  QINGXIGONGYIYANZHENGHEMIEJUNGONGYIYANZHENGYINGDANGGENJUCHANPINTEDIANXUANZEZUICHAQINGKUANG,RUQINGXIGONGYIYANZHENGZHONGKAOLVCAILIAOCANLIU,MIEJUNGONGYIYANZHENGZHONGKAOLVBIAOMIANJI、KONGXILV、KONGJINGDENGYINGXIANGWEISHENGWUFUZAIDEYINSU。LUNZHENGQINGXIYANZHENGFANGFADEYOUXIAOXING,BIYAOSHIYINGDANGCAIYONGPOHUAIXINGSHIYANDUIQIQINGXIFANGFAJINXINGYANZHENG。KAOLVDAOZENGCAIZHIZAOGONGYIDEFUZAXING,QIDUOKONGJIEGOUDEQINGXIGONGYIYANZHENGYINGDANGYOUZHUCESHENQINGRENWANCHENG。

  DUIYUJINGFUZHAOMIEJUNDECHANPIN,XUMINGQUEFUZHAOJILIANGJIXIANGGUANDEYANZHENGBAOGAO,JUTIDEJILIANGQUEDINGYIJUKECANZHAOGB 18280XILIEBIAOZHUN。DUIYUJINGHUANYANGYIWANMIEJUNDECHANPIN,XUTIGONGMIEJUNJIEGUOQUERENHEGUOCHENGKONGZHIBAOGAO,JUTIKECANZHAOGB 18279XILIEBIAOZHUN。DUIYUJINGSHIREMIEJUNDECHANPIN,XUTIGONGMIEJUNGONGYICANSHUJIYANZHENGBAOGAO,JUTIKECANKAOGB 18278XILIEBIAOZHUN。

  DUIYUFEIMIEJUNBAOZHUANGDEZHONGCHANPIN,YINGDANGMINGQUETUIJIANCAIYONGDEMIEJUNFANGFABINGTIGONGQUEDINGYIJU,JIANYICANKAOWS310.2-2016《YIYUANXIAODUGONGYINGZHONGXIN DI2BUFEN:QINGXIXIAODUJIMIEJUNJISHUCAOZUOGUIFAN》。CAIYONGQITAMIEJUNFANGFADEYINGDANGTIGONGFANGFAHELIXINGLUNZHENGHEGONGYIQUERENJIGUOCHENGKONGZHIBAOGAO。

  5.CHANPINYOUXIAOQIHEBAOZHUANG

  SHENBAOCHANPINYINGDANGCANZHAOXIANXINGYOUXIAODE《WUYUANZHIRUXINGYILIAOQIXIEHUOJIAYOUXIAOQIZHUCESHENBAOZILIAOZHIDAOYUANZE(2017NIANXIUDINGBAN)》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI75HAO)TIGONGCHANPINHUOJIAYOUXIAOQIDEYANZHENGZILIAO。HUOJIAYOUXIAOQIYANZHENGZILIAOZHONGXUYAOMINGQUEMIEJUNCHANPINDEBAOZHUANGCAILIAO、BAOZHUANGGONGYIJIFANGFA、JIASULAOHUASHIYANHUO/HESHISHILAOHUASHIYANBAOGAO。JIASULAOHUASHIYANZHONGYINGMINGQUESHIYANWENDU、SHIDU、JIASULAOHUASHIJIANDEQUEDINGYIJU。LAOHUASHIYANHOUXUYAODUIBAOZHUANGWANZHENGXINGHEBAOZHUANGQIANGDUDEPINGJIASHIYAN,RURANSEYECHUANTOUSHIYAN、QIPAOSHIYAN、CAILIAOMIFENGQIANGDUSHIYAN、MONIYUNSHUDENG。RUOSHENQINGRENTIGONGQITAYILIAOQIXIECHANPINDEHUOJIAYOUXIAOQIYANZHENGZILIAO,ZEYINGDANGTIGONGQIYUBENCISHENBAOCHANPINZAIYUANCAILIAO、MIEJUNFANGFA、MIEJUNJILIANG、BAOZHUANGCAILIAO、BAOZHUANGGONGYI、BAOZHUANGFANGSHIJIQITAYINGXIANGZUJUNXINGNENGDEYINSUFANGMIANJUYOUDENGTONGXINGDEZHENGMINGZILIAO。BUTONGBAOZHUANG、BUTONGMIEJUNFANGSHIDECHANPINYINGDANGFENBIETIGONGYANZHENGZILIAO。

  DUIYUFEIMIEJUNCHANPIN,HUOJIAYOUXIAOQIDEQUEDINGYINGDANGJIANLIZAIKEXUESHIYANDEJICHUSHANG,RUWENDINGXINGSHIYAN,QIMUDESHIKAOCHACHANPINZAIWENDU、SHIDU、GUANGXIANDEYINGXIANGXIASUISHIJIANBIANHUADEGUILV,WEICHANPINDESHENGCHAN、BAOZHUANG、ZHUCUN、YUNSHUTIAOJIANTIGONGKEXUEYIJU,TONGSHITONGGUOSHIYANJIANLICHANPINDEYOUXIAOQI。YINCI,SHENQINGRENZAISHENBAOCHANPINZHUCESHIYINGDANGTIGONGCHANPINYOUXIAOQIDEYANZHENGBAOGAOJINEIBAOZHUANGCAILIAOXINXI。

  GEXINGHUAYILIAOQIXIEDEYOUXIAOQIHAIYINGDANGMANZULINCHUANGJIAOFUSHIXIANDEYAOQIU。

  6.DONGWUSHIYAN

  6.1SHIYANSHEJIYUANZE

  RUWUFALUNZHENGSHENBAOCHANPINDEGUANJIANXINGNENGZHIBIAO(RULIHUAXINGNENG、DUOKONGJIEGOUTEZHENGDENG)、SHIYONGFANWEIYUJINGNEIYISHANGSHICHANPINJUYOUYIZHIXING,KEYISHIYONGSHIDANGDEDONGWUMOXINGDUICHANPINXINGNENGJINXINGLINCHUANGQIANPINGJIA。YIGUANCHADUOKONGJIEGOUCHANPINGUZHENGHEXIAOGUOWEILI,LINCHUANGQIANDONGWUSHIYANDESHEJIYINGDANGKAOLVRUXIAJIGEFANGMIAN:

  6.1.1DONGWUMOXINGDEXUANZE:XUANZEDEDONGWUMOXINGYINGDANGNENGDAIBIAOGAICHANPINDESHIYONGFANWEI/SHIYINGZHENG、TUIJIANSHIYONGDEJIEPOUBUWEI、YUNEIGUDINGHE/HUOWAIGUDINGQIXIEPEIHESHIYONG、CHANPINTEYOUDESHIYONGFANGFA。DONGWUMOXINGDESHEJIXUKAOLVDONGWUGUGEZISHENXIUFUNENGLIDUISHIYANJIEGUODEYINGXIANG。DONGWUMOXINGYINGDANGXUANZEGUGECHENGSHUDEDONGWU。DONGWUMOXINGSHIYONGZUNXUNYUQIYONGTUDEJINSIYUANZE。

  6.1.2SHIYANFENZU:SHIYANSHEJIYINGDANGJINXINGHELIFENZU,ZHUYISHEZHIQUANMIANDEDUIZHAOZU,YIQUEBAOJIEGUODEKEXUEXING。KEBAOKUOSHIYANZU、TONGLEICHANPINDUIZHAOZU、JIASHOUSHUZU。

  6.1.3DUIZHAOYANGPINDEXUANZE:KEXUANYONGJINGNEIYISHANGSHITONGLEICHANPINZUOWEITONGLEICHANPINDUIZHAOZUDEYANGPIN,JIANYIDUIZHAOYANGPINDEXINGZHUANG、CHICUN、SHIYONGFANWEIYUSHIYANYANGPINJINSI。

  6.1.4GUANCHAQIDEXUANZE:YINGDANGGENJUCHANPINYUQIYONGTU(RUGUZHENGHEQINGKUANG)SHEZHIGUANCHASHIJIANDIAN,TONGCHANGXUSHEZHIDUOGEGUANCHASHIJIANDIAN。

  6.1.5GUANCHAZHIBIAODEXUANZE:GENJUSHIYANMUDEHECHANPINSHEJITEZHENG,ZAIGEGUANCHASHIJIANDIANXUANZEHELIDEYINGXIANGXUE、ZUZHIXUE、ZUZHIXINGTAIXUEZHIBIAOYIJIXINSHENGGUSHENGWULIXUEXINGNENGZHIBIAODENGDUIYANGPINZHIRUHOUBUWEIDEGUZHENGHEQINGKUANGJINXINGPINGJIA。

  6.2SHIYANBAOGAOYINGDANGBAOHANDEXIANGMUHENEIRONG

  6.2.1SHIYANMUDE

  SHENQINGRENGENJUCHANPINDESHEJITEZHENGHEYUQISHIYONGFANWEI,QUEDINGSHIYANMUDE。DUIYUDUOKONGJIEGOUCHANPIN,ZHENGMINGZENGCAIZHIZAODUOKONGJIEGOUKEYUZHOUWEIGUXINGCHENGGUZHENGHE。

  6.2.2ZHIRUYANGPIN

  TIGONGSHIYANYANGPINHEDUIZHAOYANGPINZAILIHUABIAOZHENG、JIAGONGGUOCHENG、MIEJUNFANGFADENGFANGMIANDEBIJIAOXINXI,LUNSHUDUIZHAOYANGPINDEXUANZELIYOU。

  6.2.3SHIYANDONGWU

  提供动物的种属、品系、来源、年龄、性别、体重、饲养环境和条件、动物饮食、动物健康状况(包括意外死亡)等信息。综合考虑观察时间点、各时间点观察指标、各观察指标所需样本量,计算所需的实验动物数量。

  6.2.4DONGWUMOXING

  TIGONGJIANMOFANGFAHEGUOCHENG,DONGWUMOXINGXUHANGAIJIBINGMOXING、JIEPOUBUWEI、ZHIRUCHICUN、CHANPINSHIYONGFANGFADENGXINXI。LUNSHUDONGWUMOXINGDEXUANZELIYOU。

  6.2.5GUANCHASHIJIANDIAN

  YILIEBIAODEXINGSHIMIAOSHUGEGUANCHASHIJIANDIANDEGUANCHAZHIBIAO。

  6.2.6QUYANGYUYANGPINZHIBEI

  MIAOSHUQUYANGFANGFA,JILUMEIYIGUANCHASHIJIANDIANDEQUYANGDONGWUSHULIANG、QUCHUZHIRUWUSHULIANG。SHUOMINGCAIYONGDEZUZHIXUEQIEPIANZHIBEIJISHU,TUXIANGFENXIRUANJIANDEMINGCHENGHEBANBENHAO。

  6.2.7SHIYANJIEGUO

  BAOKUOROUYANHEXIANWEIJINGGUANCHA。BAOKUOYINGXIANGXUE、ZUZHIXUE、ZUZHIXINGTAIXUEZHIBIAOYIJIXINSHENGGUSHENGWULIXUEXINGNENGZHIBIAODENGDUIYANGPINZHIRUHOUBUWEIDEGUZHENGHEQINGKUANG。

  6.2.8JIEGUOPINGJIA

  BAOGAOYINGDANGBAOKUODUISHIYANYANGPINHEDUIZHAOYANGPINZHIRUHOUXINGUXINGCHENG、JUBUZUZHIFANYINGDEZONGHEPINGJIAJIBIJIAO。

  (SHI)CHANPINJISHUYAOQIU

  CHANPINJISHUYAOQIUYINGDANGANZHAO《YILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2014NIANDI9HAO)JINXINGBIANXIE。TONGSHIJIEHECHANPINJUTISHIYONGDEZHIDAOYUANZEHUOZHEXIANGGUANGUOJIABIAOZHUN、XINGYEBIAOZHUNYIJICHANPINTEDIAN,MINGQUEBAOZHENGCHANPINANQUAN、YOUXIAO、ZHILIANGKEKONGDEGEXIANGXINGNENGZHIBIAOHEJIANYANFANGFA。RUDUIYUKUANGUANJIEJIATI,YINGDANGTONGSHICANKAO《KUANGUANJIEJIATIXITONGZHUCEJISHUSHENCHAZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI23HAO)HEYY 0118DEXIANGGUANYAOQIUBIANXIECHANPINJISHUYAOQIU。

  CHANPINJISHUYAOQIUZHONGZHIBIAOYINGDANGZHENDUIZHONGCHANPINZHIDING,QIEXINGNENGZHIBIAOBUYINGDANGDIYUCHANPINSHIYONGDEQIANGZHIXINGGUOJIABIAOZHUNHE/HUOQIANGZHIXINGXINGYEBIAOZHUN,JIANYANFANGFAYINGDANGYOUXIANKAOLVCAIYONGGONGRENDEHUOYIBANBUDEBIAOZHUNJIANYANFANGFA,BAOKUOTUIJIANXINGBIAOZHUN,YINGDANGZHUMINGXIANGYINGBIAOZHUNDEBIANHAOHENIANDAIHAO。

  (SHIYI)TONGYIZHUCEDANYUANNEIZHUCEJIANYANDIANXINGXINGCHANPINQUEDINGYUANZE

  TONGYIZHUCEDANYUANNEISUOJIANCEDECHANPINYINGDANGSHINENGGOUDAIBIAOBENZHUCEDANYUANNEIQITACHANPINANQUANXINGHEYOUXIAOXINGDEDIANXINGCHANPIN。YUANZESHANGYINGDANGXUANZEDENGXIAOMOXINGCHANPINJINXINGZHUCEJIANYAN。

  (SHIER)CHANPINSHENGCHANZHIZAOXIANGGUANYAOQIU

  1.GEXINGHUAZENGCAIZHIZAOYILIAOQIXIEYIGONGJIAOHUTIAOJIAN

  GEXINGHUAZENGCAIZHIZAOYILIAOQIXIEDESHENGCHANHEYANZHENGGUOCHENG,TEBIEYINGDANGDUISHEJIRUANJIAN、DAYINSHEBEI、DAYINGONGYI、HOUCHULIGONGYI,YIJIYUANCAILIAOHECHANPINDECESHI,YIJIQINGXI、BAOZHUANGHEMIEJUNDENGFANGMIANJINXINGKONGZHI。

  1.1GEXINGHUAZENGCAIZHIZAORUANJIAN、SHEBEIHECAILIAO

  1.1.1RUANJIAN

  LUNZHENGHUANZHEYINGXIANGSHUJUCAIJI、CHULI、CHUANSHU、SANWEIJIANMO、XINGNENGYUCE(RULIXUEFENXI)XIANGGUANRUANJIANDEJIANRONGXING、RONGCUOJIKEZHONGFUXING、SHUJUZHENGQUEXINGHEWANZHENGXING,QUEBAOSHIXIANYUQIXINGNENG。YINGDANGMINGQUESUOSHIYONGRUANJIANMINGCHENGHEBANBENHAO。XUJINGGUOYIGONGJIAOHUPINGTAIHUOJIEZHIJINXINGSHUJUCHUANDISHI,YINGDANGDUIPINGTAI、JIEZHIJINGGUOBIYAODEYANZHENG。

  YUGEXINGHUAZENGCAIZHIZAOYILIAOQIXIECHANPINDESHEJI、SHENGCHANXIANGGUANDEGUANJIANRUANJIAN,SHENQINGRENYINGDANGDINGQIDUIQIYOUXIAOXINGJINXINGQUEREN。DANGRUANJIANXUYAOGENGXINJISHENGJISHI,YEBIXUJINXINGZAICIQUEREN。

  1.1.2SHEBEI

  JIANLIWANSHANDESHEBEIANQUANQUEREN、CAOZUOQUEREN、XINGNENGQUERENDENGZHIDU,QUEBAOFUHEYAOQIUDESHEBEIZAIHEGEDEHUANJINGZHONGBEIZHENGQUEDESHIYONG。DINGQIDUISHEBEIDEKONGZHICHENGXUJINXINGYANZHENG,CHANSHUKONGZHICHENGXUDEYANZHENGFANGFA,BIMIANKONGZHICHENGXUDECUOWUERYINQIDEBULIANGHOUGUO。RUOSHEBEIDEKONGZHICHENGXUGENGXINHUOSHENGJI,YINGDANGJISHIQUEREN。

  1.1.3CAILIAO

  MINGQUEYUANCAILIAOHEJIAGONGZHUJI、TIANJIAJI、JIAOLIANJIDECHUSHIZHUANGTAI,BAOKUOCAILIAOHUOHUAXUEXINXI(TONGYONGMINGCHENG、HUAXUEMINGCHENG、SHANGPINMINGCHENG、CAILIAOGONGYINGSHANGDENG),YIJICAILIAOCANSHUHEBAOHANCESHIFANGFADECAILIAOFENXIZHENGSHU,JIANLIDUIQIYUANCAILIAOHUAXUECHENGFENDEJIANYANFANGFA。YUANCAILIAODEHUAXUECHENGFENYUCHENGPINXINGNENGZHIJIEXIANGGUAN,RUYINGXIANGJIAGONGGONGYIDEFENMOXINGMAO,FENMOKELIDELIJINGJIQIFENBUYIJILIUDONGXING、SONGZHUANGMIDU、YANGHANLIANGDENGZHIBIAO,YINGDANGFUHESHIYONGDEGUOJI、GUOJIAHEXINGYEBIAOZHUN。

  ZENGCAIZHIZAOGUOCHENGZHONG,CHUSHICAILIAOKENENGFASHENGZHONGDADEWULIHE/HUOHUAXUEGAIBIAN。YINCI,YINGDANGJIANCEDAYINQIANHOUCAILIAOWULIHEHUAXUECANSHUDEBIANHUA,PINGGUDUIYUZHONGCHANPINDEYINGXIANG。DUIYUBUFENKEHUISHOU、ZAILIYONGDEDAYINYUANCAILIAO,YINGDANGMINGQUEDAYINHUANJING(RE、YANGQI、SHIDU、ZIWAIXIANDENG)DUICAILIAODEHUAXUECHENGFENHEWULIXINGNENG(FENMOLIUDONGXING、LIJINGDENG)DEYINGXIANG,LUNZHENGGONGYIWENDINGXINGHELINCHUANGKEJIESHOUXING,QUEDINGZHONGFUSHIYONGDECISHUYIJIXINFENHEJIUFEN(FEIHUISHOULIAO)DEHUNHEBILI。JIANLICAILIAOHUISHOU、ZAILIYONGBIAOZHUNCAOZUOLIUCHENG。

  1.2DAYINGONGYIYANZHENG

  GENJUCHANPINDEXINGNENGYAOQIUHEYUQIYONGTU,MINGQUE3DDAYINCANGSHIHUANJINGYIJICAILIAOCHENGXINGGUANJIANCANSHU,BINGLUNZHENGHELIXING。TONGSHI,YINGDANGYANZHENGSHEBEIDEWENDINGXING。YINGDANGZHENDUIXUANYONGDEZENGCAIZHIZAOGONGYIJIGONGYICANSHUJINXINGYANZHENG,ZHENGMINGMANZUYUQIXINGNENG。RUGONGYICANSHUFASHENGBIANHUA,YINGDANGLUNZHENGQIXINGNENGBUDIYUYUANYOUYAOQIU。

  YANJIUXIALIECANSHUDUICHANPINHUOZUJIANDEYINGXIANG,BAOKUOQIXIEHUOZUJIANZAIDAYINKONGJIANZHONGDEFANGZHIWEIZHI、DAYINFANGXIANG、DAYINCENGHOU、QIXIEJIANJU、DAYINZHICHENGWUDEWEIZHI、LEIXINGHESHULIANGDENG。

  1.3HOUCHULIFANGFAYIJIYANZHENG

  HOUCHULIKENENGBAOKUOJIJIAGONG、REDENGJINGYA、RECHULI、ZHICHENGWUHUOCANLIUFENMOQUCHU、BIAOMIANCHULIDENG。YINGDANGPINGGUHOUCHULIGONGYIDUICAILIAOHEZHONGCHANPINDEANQUAN、YOUXIAOXINGDEYINGXIANG。

  1.4CHANPINDECESHI

  GEXINGHUAZENGCAIZHIZAOYILIAOQIXIEBANCHENGPINHECHENGPINYINGDANGKAOLVXIALIECESHI:

  1.4.1CHANPINCAILIAODEHUAXUECHENGFENHELIXUEXINGNENGYINGDANGFUHESHENBAOCAILIAODEXIANGGUANBIAOZHUN,LIRUNEIBUZHILIANG、XIANWEIZUZHI、LIXUEQIANGDU、GUIDINGFEIBILIYANSHENLVDENG。

  1.4.2CHANPINBIAOMIANZHILIANG、CHICUNJIJINGDU。PINGJIACHANPINYUTIGONGDE3DDAYINDEGUGEMOXINGDEPIPEIXINGJISHIYONGXING。

  1.4.3CHANPINNEIBUJIEGOU,LIRUFANGSHENGDUOKONGJIEGOUDEKONGJING、SIJING、KONGXILVDENG。

  1.4.4CHANPINDEGONGNENGXINGPINGJIA,LIRUCHANPINDEJINGTAIZHOUXIANGYASUOGANGDU、JINGTAIZHOUXIANGYASUOZUIDAZAIHE、JINGTAIZHOUXIANGJIANQIEZUIDAZAIHE、DONGTAIZHOUXIANGYASUOQIANGDU、DONGTAIZHOUXIANGJIANQIEQIANGDU、JINGTAINIUZHUANZUIDANIUJU、DONGTAINIUZHUANXINGNENGPINGJIA、JINGTAIZHOUXIANGYASUOCHENXIANGANGDU、DONGTAIPILAODENG,ZHEIXIEFENXIYINGDANGYUCHANPINYUQISHIYONGBUWEIHEYUQIYONGTUXIANGSHIYI。

  ZUICHAQINGKUANGDEXUANZEYINGDANGJIEHECHANPINCAILIAOSHUXINGCESHIHEYOUXIANYUANMONIDENGSHENGWULIXUEFENXI。RUBIYAOSHI,KETONGGUODUIKANGYANENGLI、KANGLANENGLI、KANGNIUZHUANNENGLI、KANGCEWANNENGLIDECESHI,HUODEYOUXIANYUANFENXISUOXUDECAILIAOSHUXINGCANSHU。

  1.4.5CHANPINDESHENGWUXIANGRONGXINGCESHI。

  1.4.6CHANPINDEQINGXIJIWUJUNJIANCE。

  2.ZENGCAIZHIZAOYILIAOQIXIEYIGONGJIAOHUNENGLIQUEREN

  2.1GEXINGHUASHEJI

  本部分内容是在《医疗器械生产质量管理规范》(国家食品药品监督管理总局公告2014年第64号)设计与开发章节的基础上,结合个性化增材制造医疗器械的特殊性制定,预期满足用于注册申报的个性化增材制造医疗器械设计开发的基本要求。

  YINGDANGYOULINCHUANGYISHENG、YINGXIANGKEYISHENG、GONGCHENGSHIDENGDUOXUEKEBEIJINGRENYUANGONGTONGZUJIANYIGONGJIAOHUTUANDUI。CANYUYIGONGJIAOHUSHEJIDERENYUAN,YINGDANGJINGGUOYUQIGANGWEIYAOQIUXIANGSHIYINGDEPEIXUN,JUYOUXIANGYINGLILUNZHISHIHESHIJICAOZUONENGLI,BINGZHIDINGRENYUANSHANGGANGQIANYIGONGJIAOHUNENGLIQUERENDEBIAOZHUNCAOZUOLIUCHENG,MINGQUEXIANGGUANRENYUANZAISHEJIKAIFAZHONGDEZHIZEYUQUANXIAN。SHEJIYUKAIFAHUANJIEDEXIANGGUANGUOCHENGYINGDANGWENJIANHUA。

  2.1.1SHEJIKAIFADESHURU

  YIGONGJIAOHUSHEJIRENYUANGONGTONGWANCHENGCHANPINSHEJI,QIANZIQUERENGEXINGHUAZENGCAIZHIZAOCHANPINSHEJISUOXUDESHEJIYAOQIUQINGDAN,BAOKUOHUANZHEYINGXIANGSHUJU、SHOUSHUFANGAN、GEXINGHUAZENGCAIZHIZAOCHANPINYAOQIU(CAILIAO、JIEGOU、CHICUN、BAOZHUANGJIJIAOFUFANGSHIDENG)、PEITAOSHIYONGDEQIXIEYAOQIUDENGMANZUCHANPINYUQIYONGTUDEXIANGGUANCANSHUHEYAOQIU。

  HUANZHEYINGXIANGSHUJUYINGDANGBAOKUOMANZULINCHUANGXUQIUDEGUANJIANCANSHU,JILUSUOSHIYONGRUANJIANMINGCHENGHEBANBENHAO,CAIQUMINGQUECUOSHIJIANSHAOCTHEMRIJIANCHAZHONGHANJINSHUJIATIDEWEIYING,BINGMINGQUEKEZHUISUXING。CAIJIHUANZHEYINGXIANGSHUJUSHI,YAOQUEBAOXINXIANQUAN、WANZHENG,BINGCAIQUKEKAOCUOSHIBAOHUHUANZHEYINSI。SHANGSHUNEIRONGYOUYINGXIANGKEYISHENGQIANZIQUEREN。

  2.1.2SHEJIKAIFAYANZHENGHEQUEREN

  ZHENDUIGEXINGHUAZENGCAIZHIZAOYILIAOQIXIEDESHUZIHUAMOXINGHEZHIZAOJIAGONGPINJINXINGSHEJIKAIFADEYANZHENGHEQUEREN。KEYICAIYONGYIZHONGHUODUOZHONGFANGFAYANZHENGCHANPINDUIJIEPOUPIPEIXING、SHENGWULIXUEXINGNENGDENGSHEJIKAIFASHURUHEYUQIYONGTUDEMANZUXING。FANGFAKEYIBAOKUOJISUANJIMONIFENXI、SHIYANSHIJIANCE、LINCHUANGPINGGUDENG。

  DANGHUANZHEDESHUJUZAIYUANYANZHENGMOXINGCANSHUFANWEIZHINEI,KEYICAIQUYOUXIANYUANFENXIDENGPINGJIAFANGFAPINGGUQIFENGXIAN。RUGUOHUANZHEDEJIEPOUHEBINGBIANFANWEICHAOGUOYUANSHEJIYAOQIU,YINGDANGZHONGXINJINXINGPINGGUHEYANZHENG。DUIYUCHAOCHUYIPIZHUNZHUCEFANWEIDETEZHENGJIEGOUJICANSHUYINGDANGLINGXINGZHUCESHENBAO。

  SHEJIYANZHENGHEQUERENNEIRONGYINGDANGXINGCHENG《GEXINGHUAZENGCAIZHIZAOCHANPINSHEJIFANGAN》,ZHISHAOBAOHANSHEJILIUCHENGTU、CAILIAOYAOQIU、JIEGOUTEZHENG、BAOZHUANGFANGSHI、JIAOFUFANGSHIHESHIJIAN、CHANPINJISHUYAOQIUDENGNEIRONGJIJILU。YIGONGJIAOHUTUANDUIGONGTONGQUERENBINGQIANZI。

  2.1.3SHEJIKAIFADEGENGGAI

  ZAIGEXINGHUAZENGCAIZHIZAOCHANPINDESHEJIHUOSHENGCHANGUOCHENGZHONG,YINGDANGCHONGFENKAOLVHUANZHEBINGQINGBIANHUADENGYINSUDAOZHISHEJIBUMANZUSHURUDEQINGKUANG。RUGUOJINXINGSHEJIGENGGAI,YINGDANGTIGONGCHONGFENDELIYOU,ZAICIYOUYIGONGJIAOHUTUANDUIQIANZIQUEREN。

  2.2CHANPINDEJIAOFU

  DANGGEXINGHUAYILIAOQIXIECHANPINZHIZAOWANCHENGHOU,ZAIJIAOFUJILINCHUANGYISHENGSHIYINGDANGQIANZIQUERENBINGCUNDANG。CUNDANGNEIRONGBAOKUOGEXINGHUAYILIAOQIXIEDESHUZIHUAMOXING、CHANPINBIANHAO、HUANZHEBIAOSHIDENG。

  2.3CHANPINDESHIYONG

  CONGSHIGEXINGHUAZENGCAIZHIZAOYILIAOQIXIECHANPINDESHENQINGRENYUYILIAOJIGOUYINGDANGZHIDINGXIANGYINGDEZHIDU,BINGGONGTONGZUNSHOU:

  2.3.1SHIYONGGEXINGHUAYILIAOQIXIEKAIZHANSHOUSHUDEYILIAOJIGOUYINGDANGJUYOUXIANGYINGZIZHI,BIXUZAIWEISHENGZHUGUANBUMENRENDINGDEJUYOUZHUANYEJISHUZIGEDEYILIAOJIGOUSHIYONG。LINCHUANGYISHENGZHISHAOYINGDANGJUYOUCONGYEJINGYAN,BINGJINGGUOBIYAODEPEIXUN。

  2.3.2个性化医疗器械仅用于需要使用个性化医疗器械的患者,患者或者其监护人应当签署知情同意书。申请人及医疗机构有权获得患者相应的数据信息,同时须保证相关信息安全。

  2.3.3GEXINGHUAYILIAOQIXIESHIJIYUHUANZHEDEYINGXIANGSHUJUJINXINGYANZHI,LINCHUANGYISHENGYINGDANGBAOZHENGHUANZHEQUANBUYUANSHISHUJUDEZHENSHIXING、ZHUNQUEXINGHEKEYONGXING。

  2.3.4LINCHUANGYISHENGYINGDANGCANYUZHENGTIFANGANDESHEJI,BINGDUIZUIZHONGCHANPIN、PEITAOSHOUSHUGONGJUJIXIANGGUANSHOUSHUFANGANJINXINGQUEREN。

  2.3.5WEISHIYONGDEGEXINGHUAYILIAOQIXIEYOUSHENQINGRENFUZESHOUHUI,BUDEZAIYONGYULINCHUANG。

  2.3.6SHENQINGRENHEYILIAOJIGOUYINGDANGANZHAO《YILIAOQIXIEBULIANGSHIJIANJIANCEHEZAIPINGJIAGUANLIBANFA》YOUGUANGUIDINGKAIZHANGEXINGHUAYILIAOQIXIEBULIANGSHIJIANJIANCEGONGZUO。

  ZAICHANPINQUANSHENGMINGZHOUQIZHONG,SHENQINGRENHAIYINGDANGWANCHENGYIXIANEIRONG:

  2.3.7SHENQINGRENYINGDANGJIANLISHUJUKU,YONGYUBAOCUNBINGHUANDESHUJUXINXI,BINGYOUZHUANRENFUZEWEIHUBAOGUAN。CHUFEIDEDAOHUANZHEJIYILIAOJIGOUDEXUKE,SHENQINGRENBUDEJIANGSHUJUTIGONGJIQITAJIGOUHUOGEREN。

  2.3.8SHENQINGRENYINGDANGJIANLIKONGZHICHENGXU,DINGQISHOUJI、PINGGUGEXINGHUAYILIAOQIXIELINCHUANGSHIYONGXIAOGUO,YONGYUGAIJINCHANPINXINGNENGHEJIANGDICHANPINFENGXIAN。YINGDANGJIANLIGEXINGHUAYILIAOQIXIEDESHIYONGBAOGAOZHIDU、XINXIZHUISUZHIDU、ZAIPINGJIAZHIDUHEZHONGZHICHANPINYINGYONGZHIDU。

  2.3.9PINGJIAYANZHONGBULIANGSHIJIANKEYICAIYONGANZHAOGEXINGHUAYILIAOQIXIESHENGCHANGONGYIWENJIAN,ZAITONGDENGSHENGCHANJIAGONGTIAOJIANXIASHENGCHANDEGEXINGHUAYILIAOQIXIEYANGPIN。SHENQINGRENYINGDANGBAOCUNMEIGEGEXINGHUAYILIAOQIXIEDESHEJISHENGCHANZILIAO,QUEBAOMEIGEGEXINGHUAZENGCAIZHIZAOCHANPINDEZHONGXIANXING。

  (SHISAN)CHANPINDELINCHUANGPINGJIAYAOQIU

  个性化增材制造医疗器械临床评价的目标是为了获得安全性和有效性数据,评价个性化增材制造医疗器械在治疗特殊病例和特殊解剖部位疾患的作用。如通过临床试验评价产品安全性和有效性,临床试验应当符合《医疗器械临床试验质量管理规范》(国家食品药品监督管理总局 中华人民共和国国家卫生和计划生育委员会令第25号)的相应要求,临床试验机构应当按要求在国家药品监督管理局备案。

  WUKETIDAICHANPINQINGXING

  BINGYUANYOUXIANHUOBIAOZHUNHUACHANPINBUSHIYIZUOWEIDUIZHAODE,KEYIKAIZHANBUSHAOYU10LIDEGUANCHAYANJIU,MEIGELINCHUANGJIGOUYINGDANGKAIZHANBUSHAOYU5LIYANJIU。KEYIHESHENQINGRENYIWANGDELISHISHUJUJINXINGZONGHEFENXI,FUHEBENZHIDAOYUANZEYAOQIUDEKEYINARUTONGJI。SHUYULINCHUANGJIXUHUOHANJIANBINGQINGKUANGDEKEYIYIJUXIANGGUANGUIDINGJINXINGSHIYAN。

  YINGDANGZHUYIDUIGEXINGHUAZENGCAIZHIZAOCHANPINTEDINGANQUANXINGHEYOUXIAOXINGZHIBIAOJINXINGGUANCHA。LIRUGEXINGHUAYILIAOQIXIESHIYONGGUOCHENGZHONGFASHENGDEBULIANGSHIJIAN、SHIYONGGUOCHENGZHONGLINCHUANGYISHENGCAOZUOXINGNENG、ZHIRUJIATIDECHUSHIWENDINGXING、HUANZHEDEGONGNENGHUIFUJISHENGCUNZHILIANGDEZAOQIGAISHANDENG。

  GENJUJIBINGLEIXINGHELINCHUANGHUOYIQUEDINGYANJIUZHONGDIAN,YANJIUZHONGDIANWEIZHISHAO3GEYUE,DANGAILINCHUANGBINGLIYINGDANGJIYUCHIXUGENZONG,ZHIZHILINCHUANGZHUANGUIDEWENDINGZHUANGTAI。

  XUYAOJINXINGTONGLEIDUIZHAOCHANPINQINGXING

  RUKESHELIYANGXINGDUIZHAO,ZEYINGDANGCANZHAOSUIJI、PINGXING、DUIZHAODEQIANZHANXINGLINCHUANGSHIYANYUANZE,JINXINGFEILIEXIAOXINGLINCHUANGSHIYAN。

  2.1RUXUAN、PAICHUBIAOZHUN

  DUIYUXUYAOJINXINGLINCHUANGSHIYANDEGEXINGHUAZENGCAIZHIZAOYILIAOQIXIE,QISHOUSHIZHEYINGDANGYANGEZUNCONGHUANZHEHUOYIDEQIANTI,CONGXUYAOJINXINGGEXINGHUAYILIAOQIXIEZHILIAODEHUANZHERENQUNZHONGXUANCHU。SHENQINGRENJILINCHUANGSHIYANJIGOUYINGDANGGENJUSHENBAOCHANPINDESHEJITEZHENGJIQISHIYONGFANWEIZHIDINGQILINCHUANGSHIYANDERUXUAN/PAICHU/TUICHUBIAOZHUN,BUFUHESUOYOURUXUANBIAOZHUNHUOZHEFUHERENHEYIXIANGPAICHUBIAOZHUNDEYANJIUDUIXIANGYINGBEIPAICHU。

  2.2SHOUSHIZHETUICHUBIAOZHUNJITUICHUSHOUSHIZHEDECHULI

  2.2.1TUICHUBIAOZHUN

  ①SHOUSHIZHECHEHUIZHIQINGTONGYISHU;

  ②YANZHONGWEIFANYANZHENGFANGAN;

  ③YANJIUZHERENWEIBUZAISHIHEJIXUJINXINGLINCHUANGYANZHENGZHE;

  ④ZAILINCHUANGYANZHENGQIJIANRENSHENDEFUNV;

  ⑤SHOUSHIZHESIWANG;

  ⑥SHOUSHIZHESHIFANG;

  ⑦SHENBANZHEYAOQIUZHONGZHIYANZHENG。

  2.2.2TUICHUSHOUSHIZHEDECHULI

  ①ZUIHOUYICISHENGMINGTIZHENGJILU、SHUHOUQINGKUANGHEJUBUTIZHENGJIANCHAZILIAO、YINGXIANGXUEJIANCHAZILIAO,JILUHEBINGYONGYAOHEBULIANGSHIJIANDENG;

  ②JIANGZHONGZHIYANZHENGDESHIJIANHEYUANYINXIANGXIJILUZAIBINGLIBAOGAOBIAOSHANG;

  ③DUIYINBULIANGSHIJIANERZHONGZHIYANZHENGDEBINGRENBIXUSUIFANGZHIBULIANGSHIJIANDEDAOJIEJUEHUOWENDING。

  ④《YILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLIGUIFAN》GUIDINGDEQITAXIANGGUANYAOQIU。

  2.3GEXINGHUAYILIAOQIXIEZHIRUSHOUSHUCAOZUOZHIXINGYAOQIU

  WEIJIANGDISHOUSHUZHIRUHUANJIEDEFENGXIAN,YINGDANGZHENDUIBUTONGBUWEIDEGEXINGHUAYILIAOQIXIEYINGYONG,JIANLISHOUSHUCAOZUODEWENBENJITUSHIGUIFANZHIDAOSHISHI。GENJUXUYAOXUANZEJISUANJIDAOHANGHEFUZHUDAOBANJINXINGJINGQUESHOUSHU,YIQUEBAOGEXINGHUAYILIAOQIXIEDEJINGZHUNANZHUANG。

  2.4LINCHUANGSHIYANCHIXUSHIJIANYUCHUANGKOUQI

  LINCHUANGSHIYANDECHIXUSHIJIANQUJUEYUANQUANXINGHEYOUXIAOXINGSHUJUDEHUOQU,ZHENDUIGEXINGHUA3DDAYINQIXIEDEKONGXIJIEGOULIYUGUZHANGRUXINGCHENGYUANQIWENDINGDETEDIAN,LINCHUANGSHIYANKEZHONGDIANKAOLIANGQIXIEDECHUSHIWENDINGXING,LINCHUANGSHIYANCHIXUSHIJIANZHISHAO3GEYUE。SUIFANGNEIRONGBAOKUOHUANZHEZHUSU、TIGEJIANCHA、YINGXIANGPINGJIA、GONGNENGPINGGUDENG。

  2.5LINCHUANGSHIYANPINGJIAZHIBIAOJIPANDINGBIAOZHUN

  DUIYUXUJINXINGLINCHUANGSHIYANDEGEXINGHUAYILIAOQIXIE,GENJUZHIRUBUWEIBUTONG,CANKAOXIANYOUCHANGGUICHANPINHUOGENJUBINGBIANBUWEITEDIANSHELIZHUYAOPINGJIAZHIBIAOHECIYAOPINGJIAZHIBIAO,BINGMINGQUEPINGGUFANGFA。ZHUYAOPINGJIAZHIBIAOSHIYUSHIYANMUDEYOUBENZHILIANXIDE、NENGQUEQIEFANYINGQIXIELIAOXIAOHUOANQUANXINGDEZHIBIAO。CIYAOPINGJIAZHIBIAOSHIYUSHIYANMUDEXIANGGUANDEFUZHUXINGZHIBIAO。

  2.6DUIZHAOCHANPINDEXUANZE

  DUIKAIZHANLINCHUANGSHIYANDEGEXINGHUAYILIAOQIXIE,DUIZHAOCHANPINYINGDANGJINKENENGXUANZEMUQIANLINCHUANGZHENGGUANGFANSHIYONGDE、DUIXIANGYINGSHIYINGZHENGDELIAOXIAOYIBEIZHENGSHIBINGDEDAOGONGRENDEDENGXIAOCHANPIN。DUIZHAOCHANPINDECAILIAO、SHEJI、SHIYINGZHENGYUSHIYANCHANPINJUYOUKEBIXING,YINGDANGTIGONGDUIZHAOCHANPINDEXUANZEYIJU。

  2.7TONGJIFENXIFANGFA

  YINGDANGMINGSHIJUTIDETONGJIFENXIFANGFAYIJITONGJIFENXIRUANJIANJIBANBEN。SHUJUFENXISHIYINGDANGKAOLVSHUJUDEWANZHENGXING,SUOYOUQIANSHUZHIQINGTONGYIBINGSHIYONGLESHOUSHICHANPINDESHOUSHIZHEBIXUNARUFENXI。SHUJUDETICHUHUOPIANYISHUJUDECHULIBIXUYOUKEXUEYIJUHEXIANGXISHUOMING。

  LINCHUANGSHIYANDESHUJUFENXIYINGDANGJIYUBUTONGDEFENXIJI,TONGCHANGBAOKUOQUANFENXIJI(Full Analysis Set,FAS)、FUHEFANGANJI(Per Protocol Set,PPS)HEANQUANJI(Safety Set,SS),YANJIUFANGANZHONGYINGDANGMINGQUEGEFENXIJIDEDINGYI。QUANFENXIJIZHONGTUOLUOBINGLI,QIZHUYAOYANJIUZHONGDIANDEQUESHIZHIDETIANBUFANGFADENGYINGDANGZAIFANGANZHONGSHIXIANYUYISHUOMING,BINGJINXINGBUTONGFENXICELVEDELINGMINDUFENXI,YIPINGJIAQUESHISHUJUDUIYANJIUJIEGUOWENDINGXINGDEYINGXIANG。

  ZHUYAOYANJIUZHONGDIANZHIBIAODEFENXIYINGDANGTONGSHIZAIQUANFENXIJIHEFUHEFANGANJISHANGJINXING,ANQUANXINGZHIBIAODEFENXIYINGDANGJIYUANQUANJI。

  LINCHUANGSHIYANSHUJUDEFENXIYINGDANGCAIYONGGUONEIWAIGONGRENDEJINGDIANTONGJIFENXIFANGFA。LINCHUANGSHIYANFANGANYINGDANGMINGQUETONGJIJIANYANDELEIXING、JIANYANJIASHE、PANDINGLIAOXIAOYOULINCHUANGYIYIDEJIEZHI(FEILIEXIAOJIEZHI)DENG,JIEZHIDEQUEDINGYINGDANGYOUYIJU。

  DUIYUZHUYAOYANJIUZHONGDIAN,TONGJIJIEGUOXUCAIYONGDIANGUJIJIXIANGYINGDE95%KEXINQUJIANJINXINGPINGJIA。BUNENGJINJIANGpZHIZUOWEIDUIZHUYAOYANJIUZHONGDIANJINXINGPINGJIADEYIJU。

  DUIYANZHENGQIJIANFASHENGDESUOYOUYOUHAISHIJIANDEZHONGLEI、YANZHONGCHENGDU、FASHENGPINLVJIYUYANZHENGCHANPINDEGUANXIJIANGLIEBIAOMIAOSHU。

  SHENQINGRENYINGDANGTIGONGJIYUSUOYOULINCHUANGSHIYANSHUJUDETONGJIFENXIBAOGAO,YIBIANLINCHUANGSHIYANZUZHANGDANWEIGENJUCIBAOGAOZHUANXIELINCHUANGSHIYANZONGJIEBAOGAO。

  3.GEXINGHUAYILIAOQIXIEGENJUQINEIZAIGUILV,KEYICAIYONGLINCHUANGPINGJIA、DONGWUSHIYANHEGONGNENGSHIYANDENGFANGFA,JINXINGZONGHEFENGXIANPINGGU。LINCHUANGPINGJIAKEYIYIJUFENGXIANYAOSUJINXINGSHEDING,PINGGUDUIFENGXIANYAOSUDEKONGZHICHENGDU。

  (SHISI)CHANPINDEBULIANGSHIJIANLISHIJILU

  YINGDANGANYAOQIUSHOUJI、JILU、TIJIAOCHANPINXIANGGUANDEBULIANGSHIJIANLISHIJILU。

  (SHIWU)CHANPINSHUOMINGSHUHEBIAOQIANYAOQIU

  产品说明书、标签和包装标识应当符合《医疗器械说明书和标签管理规定》要求,还应当符合相关国家标准、行业标准的要求,例如YY/T 0466.1—2016《医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求》。

  CHUYIPIZHUNXINXIWAI,SHUOMINGSHUHEBIAOQIANZHONGYINGDANGMINGQUECHANPINWEIGEXINGHUAYILIAOQIXIE,BUCHONGHUANZHETEZHENGBIAOSHI、LINCHUANGYISHENGSHUMIANQUERENCHANPINSHEJIFANGANDEXINXIHUOWENJIANBIANHAOJIQITAXUYAOBUCHONGDEXINXI。

  三、审查关注点

  YINGYONGBENZHIDAOYUANZEJINXINGJISHUSHENPINGSHI,CHUSHENCHAYONGYUGU、GUANJIEHEKOUQIANGYINGZUZHIDEWUYUANZHIRUXINGYILIAOQIXIECHANPINDEANQUANXINGHEYOUXIAOXINGWAI,HAIZHONGDIANGUANZHUSHIXIANGEXINGHUACHANPINSHEJI、WANCHENGZENGCAIZHIZAOJIAGONGDENENGLIHEZHILIANG。

  四、编写单位

  BENZHIDAOYUANZEYOUGUOJIAYAOPINJIANDUGUANLIJUYILIAOQIXIEJISHUSHENPINGZHONGXINBIANXIEBINGFUZEJIESHI。


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