MedXpert Regulatory Hub

Read-only MCP server for medical device regulatory lookups: NMPA UDI records, FDA 510(k), PMA and product classification, plus a keyword search over a…

What you can do

• Look up NMPA UDI records by main DI, product name or registration number
• Query FDA 510(k) clearances by K-number, company or product
• Query FDA PMA approvals by PMA number, company or product
• Look up FDA product classification by product code or name
• Keyword-search a 20-hub regulatory knowledge base covering CN, US, EU and JP

When to use it

Useful when you need to check device registration, clearance or classification status while drafting regulatory documents, comparing markets, or answering questions about a specific device or company. All tools are read-only, so it suits research and reference work rather than data entry.

Requirements

Runs locally over stdio; install the medxpert-reg-hub package from PyPI and start the medxpert-mcp command. The wheel ships without the full dataset, so you must supply your own SQLite database via MEDXPERT_DB and a references directory via MEDXPERT_REFS, for example by cloning the project's GitHub repository. Desktop only; no authentication declared.