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Regmd MCP Server

@zubi-wiz

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トランスポート

stdio

作者

zubi-wiz

投稿者

Zubi

Regmd MCP Server について

概要はまだありません

Regmd MCP Server の設定

以下の設定を使って、このサーバーを MCP 対応クライアントに追加してください。

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

Regmd MCP Server のツール

4

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

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 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?"

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