Regulatory Dossier Writing（医械注册申报资料编写）
Compile submission-ready medical device registration dossiers by market — China NMPA, US FDA (510(k)/eSTAR), EU MDR, Japan PMDA and global convergence. Compile submission-ready medical device registration dossiers by market — China NMPA, US FDA (510(k)/eSTAR), EU MDR, Japan PMDA and global convergen
as observed 2026-11-06T15:44:01.797Z- Identifier
medical-device-reg-dossier- Source
- ClawHub
- Version observed
- 0.1.4
- Source repository
- not published
- Repository observation
- No source repository listed
- First observed here
- 2026-09-23T00:21:02.725Z
- Observations recorded
- 2
- Installs (reported upstream)
- 1
- Weekly downloads (upstream)
- 336
- Declared license
- MIT-0
Observation history
2026-11-06T15:44:01.797Z
Fields that differed: changelog displayName latestVersion summary
| Field | Before | After |
|---|---|---|
changelog |
"首次发布：按市场结构汇编可提交的注册申报资料（NMPA/FDA/MDR/PMDA）" | "上架标准 v1.0：简介英文在前中文在后、补 6 条双语触发词、补分类 tags、包内附 llms.txt 并在生态块给出直达链接。技能逻辑未改动。" |
displayName |
"医械注册申报资料编写" | "Regulatory Dossier Writing（医械注册申报资料编写）" |
latestVersion |
"0.1.0" | "0.1.4" |
summary |
"医疗器械注册申报资料编写助手——按市场结构汇编可提交的注册申报资料：中国 NMPA 注册、美国 FDA注册（510(k)/eSTAR）、欧盟 MDR、日本 PMDA 及全球协调路径。以 IMDRF STED 六章为骨架，映射各市场 Annex 章节，输出综述、研究资料、临床评价、标签等模块，并给出注册分类判定与资料清单梳理。生成后用 medical-dev | "Compile submission-ready medical device registration dossiers by market — China NMPA, US FDA (510(k)/eSTAR), EU MDR, Japan PMDA and global convergence. Compile submission-ready me |
Correction
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