MDCG2020-7 上市后临床随访(PMICF)计划模板制造商和公告机构指南

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3.0 一如既往 2026-03-17 0 1.38MB 12 页 120质量币
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MDCG 2020-7
Medical Device Coordination Group Document
Medical Device
MDCG 2020-7
󳔋󴔃󳬏󳔵󴖋󷶐󷋀󾘉PMCF󾘊󷊢󳤓󵄢󴺀 󳤷󷜡󳱇󳮍󳡭
󳭋󴸻󴺅󴨈󳩘
2020 󴕵 4 󴸉
󴸭󴲈󳗷󴓳󶪸󵰲󾘉󵈨󵷠󾘊2017/745 󳫸󵏖󷃅󶈭 103 󴹢󷊿󶇌󵶅󳨼󵲘󳵩󴾱󳩐󷌄󴌐󶗅󾘉MDCG󾘊󷊥󳫰󱜃MDCG 󵰲󴥁󴸊󴤑󳭙󳷾󵶅󳗤󶽩󶗅󴤑󾘍󵰲
󵈨󵷠󴃕󳭙󳘛󵶅󳔁󳬎󳗤󶽩󴧆󳗼󳔼󴔮󱜃󴸭󴲈󳗷󴕷󷹟󵈨󵷠󴃕󳭙󳘛󴲈󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵷠󴃕󳭙󳘛󵶅󴊙󴲺󶇌󳸻󱜃󴸭󴲈󳗷󳔮󶽩󷚿󵶅󳗼󳙖󷃃
󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫󴸊󵈨󵷠󵏖󷵣󶟾󴀠󴋺󵈨󵷠󵏖󴚌󳙝󳣻󳡸󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃
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MDCG 2020-7
Medical Device Coordination Group Document
Medical Device
󳔋󴔃󳬏󳔵󴖋󷶐󷋀󾘉PMCF󾘊󷊢󳤓󵄢󴺀 󳤷󷜡󳱇󳮍󳡭
󳭋󴸻󴺅󴨈󳩘
2
MDCG 2020-7
Medical Device Coordination Group Document
Medical Device
󵷯󴙖
󴘖󷄁 ....................................................................................................................................................................................................................................................................... 4
󳔋󴔃󳬏󳔵󴖋󷶐󷋀󷊢󳤓󵄢󴺀.....................................................................................................................................................................................................................................5
A 󷟩󳤇. 󳤷󷜡󳱇󶝕󶏼󷋧󴟆 ..................................................................................................................................................................................................................................5
B 󷟩󳤇 󳨼󵲘󳵩󴾱󴫐󷛱󳫋󷃅󴼽 .......................................................................................................................................................................................................................... 6
C 󷟩󳤇. 󳔏 PMCF 󵷹󳡴󵶅󵐼󳦩󾘛󷜛󵰩󳫋󵥺󴊛󵶅󴲺󵏖󳮍󶄌󴖐 ..........................................................................................................................................................................7
D 󷟩󳤇. 󴋺󴦁󴸰󴲈󴽤󵷹󳡴󷟩󳤇󵶅󴘖󵰩 ............................................................................................................................................................................................................. 9
E 󷟩󳤇. 󴋺󶉊󴱉󴤗󶍼󳘽󳵩󴾱󵷹󳡴󳔵󴖋󴱱󴩯󵶅󷋅󳘱 .........................................................................................................................................................................................10
F 󶦃. 󳗼󳙖󷜃󵰩󵶅󷜛󵰩󷃅󶨄󱜂󳩐󷌄󴼈󳣇󴤗󷜃󵰩󵶅󴨈󴋽󴲈󳗷󵶅󴘖󵰩 .............................................................................................................................................................11
G 󷟩󳤇. - 󷾅󷊢 PMCF 󷋅󳘱󴦦󳭋󵶅󴳦󴸠 ......................................................................................................................................................................................................... 12
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标签: #指南 #模板 #MDCG

摘要:

MDCG20207MedicalDeviceCoordinationGroupDocumentMedicalDeviceMDCG20207NTN4PMCFRjgR6UFTQlTJggcSW2020t4ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0MDCGu1bgbTXVvNhbu1kvYTXOvNTNhbNN0geNvkvYTXOeNNNSfkvYTXOvezW0geNNhvNOUpWGNQwglgRSgkvlbYkvlOQQwggRv01MDCG20207MedicalDeviceCoordinationGroupDocumentMedicalDeviceNTN4...

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MDCG2020-7 上市后临床随访(PMICF)计划模板制造商和公告机构指南.pdf

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作者:一如既往 分类:法规规范 价格:120质量币 属性:12 页 大小:1.38MB 格式:PDF 时间:2026-03-17
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