Content
# Medical Device and IVD Registration Document Writing Assistant
Let AI help you efficiently write medical device and IVD registration documents.
This project is an open-source Skill that can be installed in your Claude Code. Once installed, simply describe the product in natural language, and AI will automatically query the classification directory, retrieve applicable national standards, and generate an initial draft of the registration document sections in NMPA format.
## What It Can Do For You
- **Automatic Classification**: Enter the product name, and automatically determine the medical device classification code and management category.
- **Automatic Standard Retrieval**: Automatically retrieve applicable national standards (YY, GB/T, etc.), eliminating the need for manual searches.
- **Generate Initial Draft**: Based on authoritative data, generate product overview materials, product technical requirements, and other sections, with standard sources annotated.
- **Reduce Errors**: All technical indicators must reference specific standard numbers and section numbers, avoiding fabrication or omission.
## Suitable For
- Medical device registration applicants
- Regulatory Affairs (RA) specialists
- Enterprise quality managers
- R&D personnel who need to quickly understand product classification and applicable standards
## Prerequisites
1. Install an MCP-supported agent tool on your computer, such as Claude Code, OpenAI Codex, Cursor, or Kimi Code CLI.
2. Obtain an API Key for the Hippo MCP Service. Apply at: www.medmcp.cn
> This Skill is free and does not collect your enterprise private data. However, querying classification directories and national standards requires calling backend data services, so you need to apply for an API Key from the service provider. The free account limits MCP calls to 50 times/day.
## Quick Start
### 1. Download This Skill
```bash
git clone https://github.com/your-org/medreg-mcp-skill.git
cd medreg-mcp-skill
```
### 2. One-Click Installation
Run the `install.sh` script in the repository root directory based on your client:
```bash
./install.sh claude # Install to Claude Code (copy to ~/.claude/skills/)
./install.sh cursor # Write to Cursor MCP configuration
./install.sh codex # Write to Codex CLI MCP configuration
./install.sh kimi # Install to Kimi Code CLI (copy to ~/.kimi-code/skills/) and write MCP configuration
./install.sh all # Automatically detect and configure all installed clients
```
The script will detect if the client exists, automatically install Skill files, or merge and write MCP configurations, and prompt you to input your API Key.
### 3. Start Using
The `prompts/` directory stores independent chapter generation prompts, categorized by **product type** and **registration type**. After installation, you can directly call `/medreg-mcp-skill`, specifying the product type, registration type, product name, and chapter name:
| Product Type | Registration Type | Chapter | Corresponding Prompt File | Example Instruction |
|----------|:-----------:|:-----------:|:---------------:|:---------:|
| Medical Device | Registration | Product Overview | `prompts/Medical Device/Registration/01-CH2.2-Product Overview (R).md` | `/medreg-mcp-skill Help me write a product overview for a disposable infusion set medical device registration.` |
| Medical Device | Registration | Product Technical Requirements | `prompts/Medical Device/Registration/02-CH3.4.2-Product Technical Requirements (R).md` | `/medreg-mcp-skill Help me write product technical requirements for a disposable infusion set medical device registration.` |
| ... | ... | ... | ... | ... |
AI will automatically query classification directories and applicable standards, generating Markdown format chapter content.
## Manual Configuration (Optional)
If you don't want to use `install.sh` or if your client is not covered by the script, you can manually add an MCP Server and import prompts.
### Configuration Example
```json
{
"mcpServers": {
"medmcp": {
"url": "https://www.medmcp.cn/mcp/json",
"headers": {
"X-API-Key": "med_mcp_xxxxxxxxxxxxxxxxxxxxxx"
}
}
}
}
```
> Replace the `X-API-Key` value with your actual API Key obtained from the service provider.
> The configuration example uses HTTPS to communicate with the server; do not use plain HTTP to transmit API Keys to avoid eavesdropping risks.
See [`mcp-config.example.json`](mcp-config.example.json) for the complete configuration example.
### Client Configuration Methods
| Client | Configuration Method | Supports install.sh |
|--------|----------|---------------------|
| **Claude Code** | Execute `claude mcp add`, or manually write to `~/.claude/settings.json` | ✅ `./install.sh claude` |
| **Claude Desktop** | Write to `claude_desktop_config.json` (see below) | ❌ Manual configuration required |
| **OpenAI Codex** | Execute `codex config`, or manually write to `~/.codex/config.toml` | ✅ `./install.sh codex` |
| **Cursor** | Write to `~/.cursor/mcp.json` (or project-level `.cursor/mcp.json`) | ✅ `./install.sh cursor` |
| ... | ... | ... |
### Claude Desktop
Configuration file path:
- macOS: `~/Library/Application Support/Claude/claude_desktop_config.json`
- Windows: `%APPDATA%\Claude\claude_desktop_config.json`
- Linux: `~/.config/Claude/claude_desktop_config.json`
Write the JSON configuration example above, save, and restart Claude Desktop to invoke related tools in conversations.
### OpenAI Codex
Codex CLI uses a TOML configuration file located at `~/.codex/config.toml`. Execute `codex config` or edit the file directly to add:
```toml
[mcp_servers.medmcp]
url = "https://www.medmcp.cn/mcp/json"
[mcp_servers.medmcp.headers]
X-API-Key = "med_mcp_xxxxxxxxxxxxxxxxxxxxxx"
```
### Cursor
Configuration file path:
- macOS / Linux: `~/.cursor/mcp.json`
- Windows: `%USERPROFILE%\.cursor\mcp.json`
Also supports project-level configuration `.cursor/mcp.json`. Write the same JSON configuration as Claude Desktop.
### Windsurf
Write to `~/.codeium/windsurf/mcp_config.json`, with content using the JSON configuration above; or click **Configure MCP** in Cascade to add manually.
### Cline
CLI version writes to `~/.cline/mcp.json`; VS Code extension version writes to `~/.cline/data/settings/cline_mcp_settings.json`. Configuration example:
```json
{
"mcpServers": {
"medmcp": {
"type": "streamableHttp",
"url": "https://www.medmcp.cn/mcp/json",
"headers": {
"X-API-Key": "med_mcp_xxxxxxxxxxxxxxxxxxxxxx"
}
}
}
}
```
> If the Cline version defaults to SSE, adjust the `type` field according to the official documentation.
### Kimi Code CLI
Execute:
```bash
kimi mcp add
```
Or write to `~/.kimi/mcp.json` / `~/.kimi-code/mcp.json`:
```json
{
"mcpServers": {
"medmcp": {
"url": "https://www.medmcp.cn/mcp/json",
"headers": {
"X-API-Key": "med_mcp_xxxxxxxxxxxxxxxxxxxxxx"
}
}
}
}
```
### Kimi Intelligent Assistant
Find **MCP Configuration** in Kimi Intelligent Assistant settings, fill in the service address `https://www.medmcp.cn/mcp/json`, and API Key.
## Current Chapter Generation
### Medical Device
| Registration Type | Product Overview | Product Technical Requirements |
|----------|:-----------:|:-----------:|
| Registration (Initial) | ✅ | ✅ |
| Change Registration | ✅ | ✅ |
| Change Filing | ✅ | — |
| Continued Registration | — | ✅ |
### IVD
| Registration Type | Product Overview | Product Technical Requirements |
|----------|:-----------:|:-----------:|
| Registration (Initial) | ✅ | ✅ |
| Change Registration | ✅ | ✅ |
| Change Filing | ✅ | — |
| Continued Registration | — | ✅ |
Other chapters and research materials will be added gradually.
## Data and Privacy Statement
- Your enterprise private data (e.g., process flow, research data, clinical trial data) will not be uploaded to this Skill.
- The Skill only teaches you how to call data services; the specific query process is completed in your local Agent environment.
- Generated content is for reference only; please review and confirm according to enterprise actual conditions and regulatory requirements before formal submission.
## Project Directory Description
The repository root directory serves as both a Claude Code Skill package and user documentation entry:
```
medreg-mcp-skill/
├── README.md # This file (user documentation, not part of Skill runtime context)
├── LICENSE # Open-source license
├── mcp-config.example.json # MCP configuration example
├── SKILL.md # Claude Code Skill entry (including two-dimensional routing)
├── prompts/ # Chapter generation prompts
│ ├── System Prompt-Basic.md
│ ├── Medical Device/
│ │ ├── Registration/
│ │ ├── Change Registration/
│ │ ├── Change Filing/
│ │ └── Continued Registration/
│ └── IVD/
│ ├── Registration/
│ ├── Change Registration/
│ ├── Change Filing/
│ └── Continued Registration/
├── templates/ # Chapter output templates
│ ├── Medical Device/
│ └── IVD/
├── validation/ # Self-inspection list
│ ├── Medical Device/
│ └── IVD/
├── workflows/ # Standard workflow
└── scripts/
└── verify_references.py # Reference consistency check script
```
> `README.md` is for human users; Claude Code does not load it during Skill runtime. The Skill entry is `SKILL.md`, with relative paths (e.g., `prompts/`, `templates/`) resolved based on the repository root directory.
## Local Verification
After modifying prompts, templates, or self-inspection lists, run the reference consistency check script to ensure no broken internal path references in Markdown files:
```bash
python3 scripts/verify_references.py
```
The script scans Markdown files in `prompts/`, `templates/`, `validation/`, and `workflows/`, checks referenced relative paths for existence, and verifies the minimum file set for each product type and registration type combination.
## Contributing
Feel free to submit Issues and Pull Requests. Keep documentation and comments in Simplified Chinese.
## License
[MIT](LICENSE)
