Content
# regmd-mcp
MCP server for **[regMD](https://regmd.dev)** — Global Medical Device Regulatory Intelligence.
Classify devices, query regulatory alerts, and find market expansion pathways across 15 jurisdictions — all from your AI assistant.
## Install
```bash
npx regmd-mcp
```
Or install globally:
```bash
npm install -g regmd-mcp
regmd-mcp
```
## Configure
### Claude Desktop
Add to `~/Library/Application Support/Claude/claude_desktop_config.json`:
```json
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": ["-y", "regmd-mcp"],
"env": {
"REGMD_API_KEY": "your_api_key"
}
}
}
}
```
### OpenClaw
Add to your OpenClaw MCP config:
```json
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": ["-y", "regmd-mcp"],
"env": {
"REGMD_API_KEY": "your_api_key"
}
}
}
}
```
### Cursor / Windsurf / Any MCP Client
```json
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": ["-y", "regmd-mcp"],
"env": {
"REGMD_API_KEY": "your_api_key"
}
}
}
}
```
## Tools
### `classify_device`
Classify a medical device across global regulatory jurisdictions.
**Example:** "Classify a wireless blood pressure monitor for FDA and EU MDR"
**Parameters:**
- `deviceName` (required) — Device name
- `deviceDescription` (required) — Description of the device
- `intendedPurpose` (required) — Clinical intended use
- `targetMarkets` (required) — Array of jurisdiction codes: `US`, `EU`, `SG`, `AU`, `JP`, `CN`, `CA`, `KR`, `IN`, `BR`, `TH`, `MY`, `VN`, `PH`, `HK`
- `deviceCategory` — `general`, `samd`, `implant`, `ivd`, `active`, `non_active`, `in_vitro`
- `contactType` — `non-invasive`, `invasive-orifice`, `surgically-invasive`, `implantable`, `no-contact`
- `durationOfUse` — `transient` (<60min), `short-term` (<30 days), `long-term` (>30 days)
- `isActive` — Electrically powered (boolean)
- `hasSoftware` — Contains software (boolean)
### `list_jurisdictions`
List all 15 supported regulatory jurisdictions with agency names and details.
### `get_alerts`
Query recent regulatory alerts from FDA, EU-MDCG, and HSA.
**Example:** "Show me critical FDA alerts from the last 7 days"
**Parameters:**
- `jurisdiction` — `fda`, `eu-mdr`, `hsa`, or `all`
- `urgency` — `critical`, `plan`, `awareness`, or `all`
- `limit` — 1-50 (default: 10)
- `days` — Last N days (1-90, default: 30)
### `find_pathway`
Find regulatory pathway between jurisdictions.
**Example:** "What's the pathway from FDA clearance to EU MDR for a Class II device?"
**Parameters:**
- `fromJurisdiction` (required) — Source jurisdiction code
- `toJurisdiction` (required) — Target jurisdiction code
- `deviceCategory` — Device category
- `riskClass` — Risk class in source jurisdiction
## Coverage
🇺🇸 FDA · 🇪🇺 EU MDR · 🇸🇬 HSA · 🇦🇺 TGA · 🇯🇵 PMDA · 🇨🇳 NMPA · 🇨🇦 Health Canada · 🇰🇷 MFDS · 🇮🇳 CDSCO · 🇧🇷 ANVISA · 🇹🇭 Thai FDA · 🇲🇾 MDA · 🇻🇳 VMOH · 🇵🇭 FDA-PH · 🇭🇰 MDCO
## API
The MCP server connects to the regMD REST API at `https://regmd.dev/api/v1`.
- **Free:** Device classification (basic)
- **$99 Lifetime Deal:** Full access — classification, portfolio, alerts, pathways, timeline, compliance
Get your API key at [regmd.dev](https://regmd.dev).
## Environment Variables
| Variable | Default | Description |
|---|---|---|
| `REGMD_API_URL` | `https://regmd.dev` | API base URL |
| `REGMD_API_KEY` | — | API key for authenticated endpoints |
## License
MIT
