regmd-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.

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 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.

Environment Variables

Install

npx regmd-mcp

Or install globally:

npm install -g regmd-mcp
regmd-mcp

License

MIT