MDCG 2024-3 医疗器械临床试验临床试验计划内容指南

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3.0 一如既往 2026-03-17 14 2.02MB 21 页 120质量币
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MDCG 2024-3
Medical Device Coordination Group Document
Medical Device
MDCG 2024-3
󳨼󵲘󳵩󴾱󳔵󴖋󷋖󸆍󳔵󴖋󷋖󸆍󷊢
󳤓󳢆󴊺󴨈󳩘
2024 󴕵 3 󴸉
󴸭󴲈󳗷󴓳󶪸󵰲󾘉󵈨󵷠󾘊2017/745 󳫸󵏖󷃅󶈭 103 󴹢󷊿󶇌󵶅󳨼󵲘󳵩󴾱󳩐󷌄󴌐󶗅
󾘉MDCG󾘊󷊥󳫰󱜃MDCG 󵰲󴥁󴸊󴤑󳭙󳷾󵶅󳗤󶽩󶗅󴤑󾘍󵰲󵈨󵷠󴃕󳭙󳘛󵶅󳔁󳬎󳗤
󶽩󴧆󳗼󳔼󴔮󱜃󴸭󴲈󳗷󴕷󷹟󵈨󵷠󴃕󳭙󳘛󴲈󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵷠󴃕󳭙󳘛󵶅󴊙
󴲺󶇌󳸻󱜃󴸭󴲈󳗷󳔮󶽩󷚿󵶅󳗼󳙖󷃃󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫󴸊󵈨󵷠󵏖󷵣󶟾󴀠
󴋺󵈨󵷠󵏖󴚌󳙝󳣻󳡸󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃
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MDCG 2024-3
Medical Device Coordination Group Document
Medical Device
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MDCG 2024-3
Medical Device Coordination Group Document
Medical Device
󵷯󴙖
󶘪󵱦󷋮 ............................................................................................................................................................................................. 4
1. 󴘖󷄁 .........................................................................................................................................................................................5
2. CIP 󵶅󵷯󵶅 ..............................................................................................................................................................................6
3. CIP 󵶅󳢆󴊺 ..............................................................................................................................................................................6
3.1. 󴜼󳤚 ............................................................................................................................................................................. 6
3.2. 󵼕󶅷󴜨󳵩󴾱󵶅󷋇󳤬󳔏󴫐󷛱 ......................................................................................................................................... 7
3.3. 󵼕󶅷󴜨󳵩󴾱󵶅󵷋󴀅󳔏󷿏󷵪󱜂󳔵󴖋󶄌󴖐󳫋󳔵󴖋󷋖󸆍󰜧󰜧8
3.3.1. 󶂐󳤪 ..............................................................................................................................................................................8
3.3.2. 󷿏󷵪 ..............................................................................................................................................................................9
3.3.3. 󴱉󵷋󷿏󷵪󵋕 ............................................................................................................................................................... 10
3.4. 󳔵󴖋󵼕󶅷󵶅󵷹󳡴󴜨 ....................................................................................................................................................10
3.5. 󵷯󴼈󳔏󳝈󷊿 ............................................................................................................................................................... 11
3.6. 󳔵󴖋󵼕󶅷󵶅󷊿󷊢 ....................................................................................................................................................... 11
3.6.1. 󷋹󴂃󷌄󴻦󶍼󳺌󳫋󳡷󷜊󴧪󵬇󵰲󶉊󳔁󶤭󳛢󴝰󾘍󳗦󳫋󳡴󳖏󳡷󵶅
󶗉󵞺󳗦󳫋󳡷󳫙󷣐󾘍󴂃󳔵󴖋󷋅󳘱󷊢󳤓󳔮󴥁󷛱 ................................................................................................................................11
3.6.2. 󴸊󳡴󳔵󴖋󷋖󸆍󳔮󴧠󵰩󵶅󷋖󸆍󳵩󴾱󳫋󳗼󳙖󴋺󵡨󳵩󴾱󵶅󳛢󴝰
󷌄󴻦 ............................................................................................................................................................................................... 12
3.6.3. 󳡴󳖏󵼕󶅷󴋺󷍢󱜂󷜊󴧪󴼈󳣇󱜂󷌄󴻦󳖻󶚥󷃅󵄢󱜂󳗤󶽩󴜨󴲺󷹣󵶅󳛢󴝰
󳡴󳖏󷌄󴻦󴋺󷍢󳔏󵷯󴼈󴋺󷍢󳕌󷳵󵶅󳡴󶏼󾘍󳗦󳫋󾘉󴂃󷜃󵰩󾘊󴸊󳡴󴘲󳧀󶚥󳙔󵶅󳛢󴝰
󵒊󳫋󵶅󳫘󷋖󶜆󳨆󴧭󳡀󶇦󱜂󴉖󴂈󱜂󳡎󵲬󳦠󶟾󳙏󳔌󶜆󴤗󶜂󴕵󳖻󶉊󱜃 ............................................................................................12
3.6.4. 󳔻󴌾󷣐󳣐󴌒󳝐󷃂󶜍󷣈󳫗󵶅󴪫󴲾󵶅󶗇󶦃󾘍󳚌󴂃󷶐󴸻󳨗󳮍󶊢󵬇󴪫󴲾
󵙝󳸩󵓸󴹃󳷡󶐡󵶅󳤇󴺑 ................................................................................................................................................................... 13
3.6.5. 󳔏󳔵󴖋󵷹󳡴󵶅󳔵󴖋󴯎󳙝󶄌󴖐󳫋󷋋󴲮󴲺󵏖󵶅󴫐󷛱
󷌄󴻦󾘍󴌥󳡷󴴰󷂂󶆂󳣻󳗼󳙖󳝐󶂼󵉤󴔹󳔵󴖋󴊟󷓶󵶅󴟆󳢶󱜃 ........................................................................................................... 13
3.6.6. 󵷒󵑌󷊢󳤓 ................................................................................................................................................................... 14
3.7. 󶗠󷊢󷊿󷊢󳔏󳤇󴺑.........................................................................................................................................................15
3.8. 󴱱󴩯󶊢󵬇 ................................................................................................................................................................... 16
3.9. CIP 󵶅󳛯󴰺 .................................................................................................................................................................16
3.10. 󳝐󶂼 CIP 󵶅󴟆󳢶 ........................................................................................................................................................17
3.11. 󷊿󴀈󷐤󳗼 ................................................................................................................................................................... 17
3.12. 󳬉󷃅󳿱󴴏 ................................................................................................................................................................... 17
3.13. 󵻦󴟆󳬍󴠐󶄌󴖐 ........................................................................................................................................................... 18
3.14. 󳔎󶥰󳖌󳗷󱜂󳔎󶥰󳵩󴾱󴙲󳯎󳮍󳵩󴾱󶘻󷵸 ................................................................................................................... 18
3.15. 󳔵󴖋󷋖󸆍󵶅󶗔󴹠󱜂󴶃󳝝󴤗󴫑󳥎󶗉󵉣 ....................................................................................................................... 19
3.16. 󳫃󳔏󳬏󵶅󶃒󵷯󴊊󴪓 ................................................................................................................................................... 20
3.17. 󳣻󵥉󴱀󶉗 ................................................................................................................................................................... 20
3.18. 󷊿󴀈󵶅󴦁󴸰󳮍󳦠󶟾󵥺󴜨 ........................................................................................................................................... 20
3.19. 󳫃󶜄󴲈󵨯 .....................................................................................................................................................................20
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标签： #医疗器械 #指南 #临床试验

摘要：

MDCG20243MedicalDeviceCoordinationGroupDocumentMedicalDeviceMDCG20243SuVhhN4N4RQcSW2024t3ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0MDCGu1bgbTXVvNhbu1kvYTXOvNTNhbNN0geNvkvYTXOeNNNSfkvYTXOvezW0geNNhvNOUpWGNQwglgRSgkvlbYkvlOQQwggRv01MDCG20243MedicalDeviceCoordinationGroupDocumentMedicalDevice2MDCG20243Medic...

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MDCG 2024-3 医疗器械临床试验临床试验计划内容指南.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：21 页 大小：2.02MB 格式：PDF 时间：2026-03-17

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