Read-only medical device regulatory data: NMPA UDI, FDA 510(k)/PMA/classification lookups.
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io.github.stevenzhao07/medxpert-reg-hub is an MCP server that read-only medical device regulatory data: NMPA UDI, FDA 510(k)/PMA/classification lookups. Its tool list has not been published yet over stdio, sse and http, requires no API key, and scores 60/100 on MCPpedia's security, maintenance and efficiency rubric.
Config is the same across clients - only the file and path differ.
{
"mcpServers": {
"io-github-stevenzhao07-medxpert-reg-hub": {
"args": [
"medxpert-reg-hub"
],
"command": "uvx"
}
}
}Are you the author?
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Read-only medical device regulatory data: NMPA UDI, FDA 510(k)/PMA/classification lookups.
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Medical Device Global Regulatory Compliance Skill Hub — 医疗器械全球注册合规的结构化资料枢纽(Agent Skills 标准格式),把 NMPA / FDA / EU MDR / PMDA 及各市场官网的法规、标准、申报系统、模板,按「市场 × 注册阶段 × 产品类别」整理成可点击直达的官方源。
⭐ 如果 medxpert-reg-hub 对你有帮助,点一个 Star 就是最大的支持! ⭐ ⭐ If medxpert-reg-hub helps you, a star means a lot! ⭐
本技能按 LGD(Lifecycle Governance Doctrine / 全程治理论 · 凡自治之物:有籍·有证·有门禁) 方法论底座构建,是 LGD 在医疗器械注册域的落地示例(reference implementation)。
- 理论仓(Theory repo):zhaoxinghua09-cell/lgd-theory(概念 DOI 10.5281/zenodo.22456647,AI 索引见其
llms.txt)- 本技能落地:28 枢纽 / 119 条官方链接浏览器级核验 / 48 实例双轨评测(见下),全程按"有籍·有证·有门禁"治理。
EN — A structured regulatory-intelligence hub for medical-device regulatory affairs (RA) engineers. 28 references organize official sources from NMPA / FDA / EU MDR / PMDA / ASEAN / LATAM by market × registration phase × product category, covering the full lifecycle: product planning → classification & pathway → technical files → QMS → submission → review & clearance → post-market. Every conclusion links to official sources; boundaries are honestly flagged as "to be verified / apply for classification determination" rather than guessed. Includes a zero-dependency CLI and a read-only DSH plugin / MCP server. CN — 医疗器械注册工程师的结构化资料枢纽。把分散在 NMPA / FDA / EU MDR / PMDA 及各市场官网的法规、标准、申报系统、模板,按「市场 × 注册阶段 × 产品类别」整理成可点击直达的官方源。覆盖从产品立项 → 分类与路径 → 技术文件 → 质量体系 → 注册申报 → 审评获批 → 上市后的全流程。每个结论附官方直达链接,边界情形明确标注"待核验 / 走分类界定",不误导。
| 对比对象 | 差异(有实测证据,2026-10-27 双轨 48 实例) |
|---|---|
| vs 官网手工翻 | 28 枢纽按市场×阶段×类别预整理,119 条官方链接已逐条浏览器级核验,免去逐站摸索 |
| vs 普通 AI 直搜 | 正确性 5.00 vs 3.83 | 可溯源 5.00 vs 2.19 | 覆盖度 5.00 vs 1.94 | 边界时效 5.00 vs 1.25 | 坑点识别 5.00 vs 1.94(全维领先) |
| vs 同类技能 | 中英双语信息齐全、全生命周期 7 阶段覆盖、免 API Key 零数据收集、CLI/MCP/DSH 三形态即装即用 |
需求立项 → 分类路径 → 技术文件 → 质量体系 → 注册申报 → 审评获批 → 上市后
│ │ │ │ │ │ │
立项/需求 NMPA/ STED/CTD GMP/ISO eRPS/ 审评时限 PMS/UDI/
调研 FDA/MDR 撰写 13485 申报实操 核查获证 上市后监管
└─────────────── 覆盖中/美/欧/日/东南亚/拉美 ─────────────────┘
| # | Hub (EN) / 枢纽(中文) | 用途 Purpose |
|---|---|---|
| 1 | 注册工程师资料枢纽 · RA Engineer Hub(主索引) | 中/美/欧/日及全球主要市场,按 7 阶段排列的官方资料直达 |
| 2 | 枢纽总览·全生命周期 7 阶段纲领 · Lifecycle Overview | 7 阶段总纲:需求立项→分类路径→技术文件→质量体系→注册申报→审评获批→上市后 |
| 3 | UDI 全球标识枢纽 · Global UDI | 中美欧 UDI 规则、发码机构、数据库 |
| 4 | 技术文件 STED 撰写枢纽 · STED/CTD Technical Files | STED 结构、CTD 思路、各模块撰写要点 |
| 5 | 注册周期·费用·有效期对比枢纽 · Cycle/Cost/Validity | 各市场周期/费用/证书有效期的横向比对 |
| 6 | 原材料供应商合规枢纽 · Supplier Compliance | 供应商资质、材质证明、13485/ROHS/REACH |
| 7 | GMP 质量体系与验证枢纽 · GMP/QMS & Validation | GMP/ISO 13485、工艺验证、再处理验证 |
| 8 | 生物相容性测试规划枢纽 · Biocompatibility | ISO 10993 系列、终点选择、试验规划 |
| 9 | 上市后监管枢纽 · Post-Market Surveill |