DocMCP Knowledge Base

Open regulatory knowledge base for medical device compliance — EU MDR, FDA, NMPA regulations, standards, and guidance documents.

简介 / Introduction

中文 | English

本仓库是一个开放的医疗器械合规知识库，收录全球主要法规体系（EU MDR、FDA、NMPA）下的法规文本、适用标准、指南文件及解读内容。

所有内容以结构化 Markdown + JSON 格式存储，可被 DocMCP AI 合规助手直接消费，也可通过 docs.team-ra.org 在线浏览。

内容范围

在线文档

访问 docs.team-ra.org 浏览完整内容（支持中英文切换、全文搜索）。

文档站点与部署

• 主站 https://docs.team-ra.org 由 Cloudflare Pages 连接本仓库 main 自动构建；修改 docs/ 后应以 Cloudflare 上生产部署成功为准（与仅同步到自托管镜像的管道不同）。
• 国内可访问的 https://docs.reguverse.com 等为另行部署的镜像，同一仓库构建产物，但不等同于 reguverse.com 上的支付/服务条款等静态页（后者在 docmcp 仓库的 payment-page/，供营销/收银台/合规链接使用，不是本 VitePress 站点导出的同一套页面）。

English

This repository is an open regulatory knowledge base for medical device compliance, covering major regulatory frameworks (EU MDR, FDA, NMPA) including regulatory texts, applicable standards, guidance documents, and interpretations.

All content is stored in structured Markdown + JSON format, directly consumable by the DocMCP AI compliance assistant, and browsable online at docs.team-ra.org.

Content Scope

Online Documentation

Visit docs.team-ra.org to browse all content (supports Chinese/English toggle and full-text search).

Doc site and deployment

• The canonical site https://docs.team-ra.org is built and hosted on Cloudflare Pages from the main branch; treat the Cloudflare production deploy as the source of truth for public doc changes.
• https://docs.reguverse.com (and similar) are separately hosted mirrors; they are not the same deployment as the legal/checkout static pages on reguverse.com (those live in the docmcp repo under payment-page/, e.g. agreement/TOS for marketing and payment flows).

Repository Structure

docmcp-knowledge/
├── eu_mdr/
│   ├── regulations/        # EU MDR / IVDR regulation texts
│   ├── standards/          # Harmonised standards (OJ published)
│   ├── mdcg/               # MDCG guidance documents (full text)
│   ├── team_nb/            # TEAM-NB position papers
│   └── meta.json           # Regulation metadata
├── fda/
│   ├── regulations/        # FDA regulations (21 CFR etc.)
│   ├── standards/          # FDA-recognized consensus standards (AAMI, ASTM, etc.)
│   ├── guidance/           # FDA guidance documents
│   └── meta.json
├── nmpa/
│   ├── regulations/        # NMPA regulations and announcements
│   ├── standards/          # Chinese standards (GB/YY)
│   ├── guidance/           # Guidance principles (指导原则) by device category
│   ├── classification/     # Device classification catalog
│   └── meta.json
├── _shared/
│   ├── standards/          # International standards (ISO/IEC) not regulation-specific
│   ├── glossary/           # Cross-regulatory terminology
│   └── templates/          # Shared document templates
├── docs/                   # VitePress documentation site source
│   ├── .vitepress/
│   │   └── config.ts
│   ├── zh/                 # Chinese content
│   └── en/                 # English content
├── scripts/
│   ├── migrate_wordpress.py    # WordPress → Markdown migration
│   ├── validate_schema.py      # JSON schema validation
│   ├── fetch_updates.py        # Automated update fetching
│   └── verify_urls.py          # Source URL verification
├── schemas/
│   ├── regulation.schema.json
│   ├── standard.schema.json
│   └── guidance.schema.json
├── CONTRIBUTING.md
├── LICENSE
└── README.md

Data Format

Each document entry consists of: - A Markdown file (.md) with the full content in both Chinese and English - A JSON metadata file (_index.json) with structured metadata for machine consumption

JSON Metadata Example

{
  "id": "nmpa-guidance-21-sw-cmde-2022-9",
  "title": {
    "zh": "医疗器械软件注册审查指导原则（2022年修订版）",
    "en": "Medical Device Software Registration Review Guidance (2022 Revision)"
  },
  "regulation": "nmpa",
  "category": "guidance/21-sw",
  "document_number": "CMDE-2022-9",
  "effective_date": "2022-03-09",
  "status": "active",
  "source_url": "https://www.cmde.org.cn/...",
  "source_url_verified": "2026-02-22",
  "source_format": "word",
  "content_zh": "guidance/21-sw/cmde-2022-9.zh.md",
  "content_en": "guidance/21-sw/cmde-2022-9.en.md",
  "translation": "ai-assisted",
  "last_verified": "2026-02-22",
  "contributor": "RASAAS"
}

Contributing

See CONTRIBUTING.md for detailed contribution guidelines.

License

Content in this repository is licensed under Creative Commons Attribution 4.0 International (CC BY 4.0).

Scripts and tooling are licensed under MIT License.

Related Projects

• DocMCP — AI-powered medical device compliance assistant (MCP server + LLM backend)
• DocMCP Office Plugin — Microsoft Word add-in for regulatory document generation
• ReguVerse — Regulatory compliance resources and services