MCP SERVERClassify a medical device across regulatory jurisdictions, find the pathway from one jurisdiction to another, and read recent alerts from FDA, EU-MDCG and HSA.
LABSCO SUMMARY
Regulatory classification decides the evidence burden, and the same device can be Class II in one market and Class III in another. A tool that answered per jurisdiction would leave the caller assembling the comparison that actually matters. The pathway finder addresses the follow-on question directly — given approval here, what is the route to there — which is otherwise consultancy work. Treat the output as orientation rather than as a filing position: classifications turn on device-specific detail and intended use, and an API answer is a starting point for a regulatory professional, not a substitute for one.
A medical-device regulatory client with four tools: device classification across jurisdictions, the supported jurisdiction list, a cross-jurisdiction pathway finder, and a regulatory alerts feed.
REGMD_API_KEY.
One command plus a key — npx regmd-mcp, then supply credentials
USE CASES
Classify across the jurisdictions at once, so the differences that drive the evidence burden are visible together.
Find the regulatory pathway from the jurisdiction you are approved in to the one you are targeting, for that specific device.
Pull recent alerts from the FDA, EU-MDCG and HSA together with the analysis, rather than watching three feeds.
Counted once with only startup setup. Other versions, modes or optional credentials may expose a different list.
classify_deviceClassify 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.
find_pathwayFind 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?"
get_alertsQuery 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.
list_jurisdictionsList all supported regulatory jurisdictions with details. Returns jurisdiction codes, full names, regulatory agencies, and supported features.
BEFORE YOU INSTALL
4 tools when we connected.
All 3 documented clients run the server on your machine.
CONTEXT COST
Rated by the size of the 4 tool definitions that ride along on every turn, not by how many there are
INSTALLATION
npx regmd-mcp{
"mcpServers": {
"regmd": {
"command": "npx",
"args": [
"-y",
"regmd-mcp"
],
"env": {
"REGMD_API_KEY": "<YOUR_REGMD_API_KEY>"
}
}
}
}MCP servers
GJB65
vdineshk
CSOAI-ORGCSOAI-ORG