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Regmd MCP Server

@zubi-wiz

代码仓库

基本信息

分类

其他

传输方式

stdio

作者

zubi-wiz

提交者

Zubi

关于 Regmd MCP Server

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Regmd MCP Server 配置

使用下面的配置,将此服务器添加到你的 MCP 客户端。

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

Regmd MCP Server 工具

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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