RegMD FAQs

Question 1

What is RegMD?

Accepted Answer

RegMD is a medical device regulatory intelligence tool designed to help users classify devices, monitor regulatory alerts, and discover market expansion pathways across 15 global jurisdictions, accessible via popular AI assistants.

Question 2

Which regulatory bodies and jurisdictions does RegMD cover?

Accepted Answer

RegMD covers 15 key global jurisdictions including US (FDA), EU (MDR), Singapore (HSA), Australia (TGA), Japan (PMDA), China (NMPA), Canada (Health Canada), South Korea (MFDS), India (CDSCO), Brazil (ANVISA), Thailand (Thai FDA), Malaysia (MDA), Vietnam (VMOH), Philippines (FDA-PH), and Hong Kong (MDCO).

Question 3

How does RegMD help with medical device classification?

Accepted Answer

RegMD allows you to classify a medical device by providing its name, description, intended purpose, and target markets. It supports additional parameters like device category, contact type, and duration of use for precise classification across global regulatory requirements.

Question 4

Can RegMD provide real-time regulatory alerts?

Accepted Answer

Yes, RegMD enables you to query recent regulatory alerts from key agencies like FDA, EU-MDCG, and HSA. You can filter alerts by urgency (critical, plan, awareness) and time (last N days) to stay updated on critical developments.

Question 5

How does RegMD integrate with AI assistants and what are the benefits?

Accepted Answer

RegMD integrates as an MCP server with popular AI clients like Claude Desktop, OpenClaw, Cursor, and Windsurf. This integration allows you to leverage RegMD's regulatory intelligence directly from your AI assistant, streamlining compliance checks, market research, and pathway discovery through conversational queries.

RegMD

RegMD

Key Features

Use Cases

Key Features

Use Cases