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MedXpert Regulatory Hub

MedXpert Regulatory Hub

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medxpert.cnLegal & Government0Updated 2d ago
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About MedXpert Regulatory Hub

MedXpert Regulatory Hub is a read-only MCP server for medical-device regulatory lookups. It serves regulatory researchers and teams with NMPA UDI, FDA records and cross-region knowledge-base search.

Key features

  1. 01Search NMPA UDI records
  2. 02Look up FDA 510(k) and PMA
  3. 03Query FDA product classifications
  4. 04Search a 20-hub regulatory knowledge base

Use cases

  1. 01Check a device’s NMPA UDI details
  2. 02Find FDA 510(k) or PMA records
  3. 03Search classification data by product code
  4. 04Research regulatory topics across regions

MCP support

Exposes read-only lookup and search tools to MCP clients, including NMPA UDI, FDA 510(k), PMA, classification and regulatory knowledge-base queries.

Configuration

Local server config is the same for every client. Copy it into your client’s MCP config file.

mcp.json · Universal config
{
  "mcpServers": {
    "stevenzhao07-medxpert-reg-hub": {
      "command": "uvx",
      "args": [
        "medxpert-reg-hub"
      ],
      "env": {
        "MEDXPERT_DB": "<MEDXPERT_DB>",
        "MEDXPERT_REFS": "<MEDXPERT_REFS>"
      }
    }
  }
}
Run commanduvx medxpert-reg-hub
Environment variables to set
MEDXPERT_DBSQLite database path (NMPA UDI / FDA 510(k) / PMA / classification data)
MEDXPERT_REFSPath to the references knowledge-base directory (20 hubs)

Local servers need a runtime on your machine (e.g. Node.js 18+). Config file locations differ by client; see your client’s docs.

Packages
pypimedxpert-reg-hub2.0.2

Tools

5

Saved tool list · updated 1d ago

ParameterTypeRequiredDescription
distringNo
reg_nostringNo
product_namestringNo

Details

From the project README

medxpert-reg-hub · MCP Server

mcp-name: io.github.stevenzhao07/medxpert-reg-hub

Read-only medical device regulatory MCP server. Tools (all read-only):

  • udi_lookup — NMPA UDI queries (main DI / product name / registration no.)
  • fda_510k_lookup — FDA 510(k) queries (K-number / company / product)
  • pma_lookup — FDA PMA queries (PMA number / company / product)
  • class_lookup — FDA product classification queries (product code / name)
  • hub_search — keyword search across the 20-hub regulatory knowledge base (CN/US/EU/JP)

Install & run

pip install medxpert-reg-hub
medxpert-mcp        # stdio MCP server

Data (MEDXPERT_DB / MEDXPERT_REFS)

The PyPI wheel is metadata-light by design (the full dataset is ~600M+ rows across SQLite). Point the server at your data:

export MEDXPERT_DB=/path/to/medxpert_device.sqlite
export MEDXPERT_REFS=/path/to/skills/references
medxpert-mcp

The reference data bundle is published in the GitHub repo stevenzhao07/medxpert-reg-hub (docs/ and skills/references/), so you can clone it and set the env vars, or use your own RA knowledge base.

License: MIT © 2026 MedXpert

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