About Regmd Mcp
Regmd Mcp connects AI assistants to regMD medical-device regulatory intelligence. It provides device classification, regulatory alerts, jurisdiction details, and pathways across 15 jurisdictions.
Key features
- 01Classify devices across jurisdictions
- 02List supported jurisdictions and agencies
- 03Query recent regulatory alerts
- 04Find pathways between jurisdictions
Use cases
- 01Check device classification for target markets
- 02Review recent FDA, EU-MDCG, or HSA alerts
- 03Explore a regulatory route between markets
MCP support
The MCP server exposes regMD API capabilities as tools for MCP clients, including classification, alert queries, jurisdiction listings, and pathway searches. It connects to the regMD REST API.
Configuration
Local server config is the same for every client. Copy it into your client’s MCP config file.
Tools
4Saved tool list · updated 3w ago
| Parameter | Type | Required | Description |
|---|---|---|---|
| deviceName | string | Yes | Name of the medical device (e.g., "Wireless Blood Pressure Monitor") |
| deviceDescription | string | Yes | Description of the device, its technology, and key features |
| intendedPurpose | string | Yes | Clinical intended use/purpose of the device |
| targetMarkets | array | Yes | Target jurisdictions as ISO codes (US, EU, SG, AU, JP, CN, CA, KR, IN, BR, TH, MY, VN, PH, HK) or agency names (FDA, TGA, HSA, PMDA, NMPA, MFDS, CDSCO, ANVISA) |
| deviceCategory | enum | No | Device category. Default: "general". Use "samd" for software-as-medical-device, "ivd" for in-vitro diagnostics, "implant" for implantable devices.general | samd | implant | ivd | active | non_active | in_vitro |
| contactType | enum | No | Patient contact type. Default: "non-invasive"non-invasive | invasive-orifice | surgically-invasive | implantable | no-contact |
| durationOfUse | enum | No | Duration of use. transient=<60min, short-term=<30days, long-term=>30days. Default: "transient"transient | short-term | long-term |
| isActive | boolean | No | Whether the device is electrically powered. Default: false |
| hasSoftware | boolean | No | Whether the device contains/is software. Default: false |
Details
From the project READMEregmd-mcp
MCP server for regMD — Global Medical Device Regulatory Intelligence.
Classify devices, query regulatory alerts, and find market expansion pathways across 15 jurisdictions — all from your AI assistant.
Install
npx regmd-mcp
Or install globally:
npm install -g regmd-mcp
regmd-mcp
Configure
Claude Desktop
Add to ~/Library/Application Support/Claude/claude_desktop_config.json:
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": ["-y", "regmd-mcp"],
"env": {
"REGMD_API_KEY": "your_api_key"
}
}
}
}
OpenClaw
Add to your OpenClaw MCP config:
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": ["-y", "regmd-mcp"],
"env": {
"REGMD_API_KEY": "your_api_key"
}
}
}
}
Cursor / Windsurf / Any MCP Client
{
"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 namedeviceDescription(required) — Description of the deviceintendedPurpose(required) — Clinical intended usetargetMarkets(required) — Array of jurisdiction codes:US,EU,SG,AU,JP,CN,CA,KR,IN,BR,TH,MY,VN,PH,HKdeviceCategory—general,samd,implant,ivd,active,non_active,in_vitrocontactType—non-invasive,invasive-orifice,surgically-invasive,implantable,no-contactdurationOfUse—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, orallurgency—critical,plan,awareness, oralllimit— 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 codetoJurisdiction(required) — Target jurisdiction codedeviceCategory— Device categoryriskClass— 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.
Environment Variables
| Variable | Default | Description |
|---|---|---|
REGMD_API_URL | https://regmd.dev | API base URL |
REGMD_API_KEY | — | API key for authenticated endpoints |
License
MIT
Comments
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