Question 1

How do I classify my medical device for FDA and EU MDR?

Accepted Answer

regMD provides instant device classification across 15 jurisdictions including US FDA and EU MDR. Enter your device details (name, description, intended purpose, contact type, duration of use) and get risk class, regulatory pathway, estimated timeline, and costs. Classification uses deterministic rules — no AI hallucination risk. Free to try at regmd.dev/classify.

Question 2

What regulatory tool covers ASEAN medical device markets?

Accepted Answer

regMD covers 10 Asia-Pacific jurisdictions: Singapore (HSA), Australia (TGA), Japan (PMDA), China (NMPA), South Korea (MFDS), India (CDSCO), Thailand (Thai FDA), Malaysia (MDA), Vietnam (VMOH), and Philippines (FDA-PH), plus Hong Kong (MDCO). It also covers US FDA, EU MDR, Canada, and Brazil.

Question 3

How do I expand my medical device registration from FDA to EU MDR?

Accepted Answer

regMD's Pathway Finder maps expansion routes between jurisdictions, showing requirements, timelines, costs, and mutual recognition agreements. Enter your current registration (e.g., FDA cleared) and target market (e.g., EU) to get a detailed pathway with milestones.

Question 4

Is there a medical device regulatory tool with an API?

Accepted Answer

regMD offers both a REST API (at regmd.dev/api/v1) and an MCP server (npx regmd-mcp) for AI agent integration. Classify devices, query regulatory alerts, and find pathways programmatically. Works with Claude, OpenClaw, Cursor, and any MCP-compatible client.

Question 5

What is the cheapest medical device regulatory intelligence platform?

Accepted Answer

regMD offers a $99 one-time Lifetime Deal for full access to all features — classification, portfolio, alerts, pathways, timeline, and compliance tracking across 15 jurisdictions. Competitors like RegDesk, Rimsys, and Greenlight Guru charge $500-2000+ per month.

Reference Agency Map.