AI Medical Device Global Compliance（AI医疗器械全球合规）
A practical guide to getting AI/ML medical devices cleared in the US, EU and China, from pathway selection and classification through clinical evidence and change control. It covers FDA 510(k)/De Novo/PMA and PCCP, EU MDR Rule 11 and AI Act timelines, and NMPA classification and change registration.
as observed 2026-11-06T15:44:01.797Z- Identifier
ai-medical-device-compliance- Source
- ClawHub
- Version observed
- 1.0.3
- Source repository
- not published
- Repository observation
- No source repository listed
- First observed here
- 2026-08-28T22:06:28.212Z
- Observations recorded
- 2
- Installs (reported upstream)
- 1
- Weekly downloads (upstream)
- 466
- Declared license
- MIT-0
Observation history
2026-11-06T15:44:01.797Z
Fields that differed: license changelog description latestVersion summary
| Field | Before | After |
|---|---|---|
license |
null | "MIT-0" |
changelog |
"v1.0.0: AI/ML medical device global regulatory compliance playbook - US FDA (510(k)/De Novo/PMA, PCCP, QMSR, SBOM), EU (MDR Rule 11, AI Act high-risk Aug 2028, CER/PMCF), China NM | "上架标准 v1.0 收尾：简介双语英文在前、补 tags、包内附 llms.txt 并给出直达链接。技能逻辑未改动。" |
description |
"AI/ML 医疗器械全球注册合规实操手册——覆盖美国FDA（510(k)/De Novo/PMA、PCCP预设变更控制、QMSR、网络安全SBOM）、欧盟（MDR Rule 11分类、AI Act高风险2028-08-02、CER/PMCF临床评价）、中国NMPA（分类界定、2026更新指南、变更注册、1000例数据本地化、创新通道）三地完整注册路径，含临 | null |
latestVersion |
"1.0.0" | "1.0.3" |
summary |
"AI/ML 医疗器械全球注册合规实操手册——覆盖美国FDA（510(k)/De Novo/PMA、PCCP预设变更控制、QMSR、网络安全SBOM）、欧盟（MDR Rule 11分类、AI Act高风险2028-08-02、CER/PMCF临床评价）、中国NMPA（分类界定、2026更新指南、变更注册、1000例数据本地化、创新通道）三地完整注册路径，含临 | "A practical guide to getting AI/ML medical devices cleared in the US, EU and China, from pathway selection and classification through clinical evidence and change control. It cove |
Correction
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