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Regmd Mcp

Regmd Mcp

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github.com/zubi-wizLegal & Government1Updated 31w ago

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

  1. 01Classify devices across jurisdictions
  2. 02List supported jurisdictions and agencies
  3. 03Query recent regulatory alerts
  4. 04Find pathways between jurisdictions

Use cases

  1. 01Check device classification for target markets
  2. 02Review recent FDA, EU-MDCG, or HSA alerts
  3. 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.

mcp.json · Universal config
{
"mcpServers": {
"regmd": {
"command": "npx",
"args": [
"-y",
"regmd-mcp"
],
"env": {
"REGMD_API_KEY": "<REGMD_API_KEY>"
}
}
}
}
Run commandnpx -y regmd-mcp
Environment variables to set
REGMD_API_KEYSecret

Local servers need a runtime on your machine (e.g. Node.js 18+). Config file locations differ by client; see your client’s docs.

Packages
npmregmd-mcp

Tools

4

Saved tool list · updated 3w ago

ParameterTypeRequiredDescription
deviceNamestringYesName of the medical device (e.g., "Wireless Blood Pressure Monitor")
deviceDescriptionstringYesDescription of the device, its technology, and key features
intendedPurposestringYesClinical intended use/purpose of the device
targetMarketsarrayYesTarget 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)
deviceCategoryenumNoDevice 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
contactTypeenumNoPatient contact type. Default: "non-invasive"non-invasive | invasive-orifice | surgically-invasive | implantable | no-contact
durationOfUseenumNoDuration of use. transient=<60min, short-term=<30days, long-term=>30days. Default: "transient"transient | short-term | long-term
isActivebooleanNoWhether the device is electrically powered. Default: false
hasSoftwarebooleanNoWhether the device contains/is software. Default: false

Details

From the project README

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 (<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

VariableDefaultDescription
REGMD_API_URLhttps://regmd.devAPI base URL
REGMD_API_KEY—API key for authenticated endpoints

License

MIT

Comments

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