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 (CDSC...

Server Regmd zubi-wiz/regmd-mcp
Category Read
Risk class Low
Parameters 00 required

What classify_device does on Regmd

AI agents call classify_device to retrieve information from Regmd without modifying anything — typically the context-gathering step in research, monitoring, and reporting workflows, before the agent takes action elsewhere.

Why classify_device needs a policy

This tool performs a data retrieval and classification operation against regulatory databases. It has no side effects on systems or data—it does not create, modify, delete, or execute external operations. The output is informational guidance for medical device regulatory compliance planning.

From the tool's definition The tool 'classify_device' returns information ('risk classification, regulatory pathway, estimated timeline, and costs') without modifying, creating, deleting, or executing operations.

Questions about classify_device

What does the classify_device tool do? +

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. It is categorised as a Read tool in the Regmd MCP Server, which means it retrieves data without modifying state.

How do I enforce a policy on classify_device? +

Register the Regmd MCP server in PolicyLayer and add a rule for classify_device: allow, deny, rate-limit, or require approval. Point your MCP client at the PolicyLayer proxy URL and the rule is enforced on every call, before it reaches Regmd. Nothing to install.

What risk level is classify_device? +

classify_device is a Read tool with low risk. Read-only tools are generally safe to allow by default.

Can I rate-limit classify_device? +

Yes. Add a rate_limit block to the classify_device rule in your PolicyLayer policy. For example, setting max: 10 and window: 60 limits the tool to 10 calls per minute. Rate limits are tracked per agent session and reset automatically.

How do I block classify_device completely? +

Set action: deny in the PolicyLayer policy for classify_device. The AI agent will receive a policy violation error and cannot call the tool. You can also include a reason field to explain why the tool is blocked.

What MCP server provides classify_device? +

classify_device is provided by the Regmd MCP server (zubi-wiz/regmd-mcp). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.

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