Regmd Mcp

by zubi-wiz

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About

Medical device regulatory intelligence. Classify devices, query alerts, find pathways across 15 jurisdictions (FDA, EU MDR, HSA, TGA, PMDA, NMPA +9 more). REST API + MCP.

Details

Author
zubi-wiz
Downloads
104
Categories
Search, Other, Security, API

Setting up with Highlight

This MCP is not yet compatible with Highlight’s one-click setup. However, you can still use it with Highlight by following these steps:

  1. Download and install Highlight from highlightai.com/download
  2. Navigate to the plugins tab and select "Add Custom Plugin"
  3. Configure the plugin with the settings below
    Plugin Name Regmd Mcp
    Command (node, npx, python, etc.)

    Please refer to the README for specific instructions on how to obtain API keys or other required environment variables.

  4. Enable "Start Automatically" if you want the plugin to start when Highlight launches

From the repository

{
  "mcpServers": {
    "regmd": {
      "command": "npx",
      "args": [
        "-y",
        "regmd-mcp"
      ],
      "env": {
        "REGMD_API_KEY": "your_api_key"
      }
    }
  }
}

classify_device

Classify a medical device across global regulatory jurisdictions. Returns risk classification, regulatory pathway, estimated timeline, and costs for each target market. Supports 15 jurisdictions: US (FDA), EU (MDR), SG (HSA), AU (TGA), JP (PMDA), CN (NMPA), CA (Health Canada), KR (MFDS), IN (CDSCO), BR (ANVISA), TH (Thai FDA), MY (MDA), VN (VMOH), PH (FDA Philippines), HK (MDCO). Use ISO country codes or agency abbreviations for targetMarkets.

list_jurisdictions

List all supported regulatory jurisdictions with details. Returns jurisdiction codes, full names, regulatory agencies, and supported features.

get_alerts

Query recent regulatory alerts from FDA, EU-MDCG, and HSA. Returns AI-analyzed alerts with urgency levels, affected device types, risk classes, action items, and source URLs. Alerts are scraped daily from official regulatory agency websites.

find_pathway

Find the regulatory pathway between two jurisdictions for a specific device type. Returns requirements, estimated timeline, costs, recognition agreements, and expansion recommendations. Useful for planning market expansion: "I have FDA clearance, what do I need for EU MDR?"

Claude Desktop / Cursor

Paste into your MCP client config file to install this server.

{
    "mcpServers": {
        "regmd mcp": {
            "regmd": {
                "command": "npx",
                "args": [
                    "-y",
                    "regmd-mcp"
                ],
                "env": {
                    "REGMD_API_KEY": "your_api_key"
                }
            }
        }
    }
}

McpServers

{
    "regmd": {
        "command": "npx",
        "args": [
            "-y",
            "regmd-mcp"
        ],
        "env": {
            "REGMD_API_KEY": "your_api_key"
        }
    }
}

MCP server forregMD— Global Medical Device Regulatory Intelligence.

Classify devices, query regulatory alerts, and find market expansion pathways across 15 jurisdictions — all from your AI assistant.

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" } } } }
{ "mcpServers": { "regmd": { "command": "npx", "args": ["-y", "regmd-mcp"], "env": { "REGMD_API_KEY": "your_api_key" } } } }
{ "mcpServers": { "regmd": { "command": "npx", "args": ["-y", "regmd-mcp"], "env": { "REGMD_API_KEY": "your_api_key" } } } }

Classify a medical device across global regulatory jurisdictions.

Example:"Classify a wireless blood pressure monitor for FDA and EU MDR"

- 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
- deviceCategorygeneral,samd,implant,ivd,active,non_active,in_vitro
- contactTypenon-invasive,invasive-orifice,surgically-invasive,implantable,no-contact
- durationOfUsetransient(<60min),short-term(<30 days),long-term(>30 days)
- isActive— Electrically powered (boolean)
- hasSoftware— Contains software (boolean)

List all 15 supported regulatory jurisdictions with agency names and details.

Query recent regulatory alerts from FDA, EU-MDCG, and HSA.

Example:"Show me critical FDA alerts from the last 7 days"

- jurisdictionfda,eu-mdr,hsa, orall
- urgencycritical,plan,awareness, orall
- limit— 1-50 (default: 10)
- days— Last N days (1-90, default: 30)

Find regulatory pathway between jurisdictions.

Example:"What's the pathway from FDA clearance to EU MDR for a Class II device?"

- fromJurisdiction(required) — Source jurisdiction code
- toJurisdiction(required) — Target jurisdiction code
- deviceCategory— Device category
- riskClass— Risk class in source jurisdiction

🇺🇸 FDA · 🇪🇺 EU MDR · 🇸🇬 HSA · 🇦🇺 TGA · 🇯🇵 PMDA · 🇨🇳 NMPA · 🇨🇦 Health Canada · 🇰🇷 MFDS · 🇮🇳 CDSCO · 🇧🇷 ANVISA · 🇹🇭 Thai FDA · 🇲🇾 MDA · 🇻🇳 VMOH · 🇵🇭 FDA-PH · 🇭🇰 MDCO

The MCP server connects to the regMD REST API athttps://regmd.dev/api/v1.

- Free:Device classification (basic)
- $99 Lifetime Deal:Full access — classification, portfolio, alerts, pathways, timeline, compliance

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