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.

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 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` (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

License

MIT