Medical Device
Regulatory Intelligence.

Classification, pathways, and guidance across 15 jurisdictions.

Classification Engine

Instant Multi-Jurisdiction Classification

Input your device characteristics. Get risk class and regulatory pathway across all 15 markets instantly.

FDA: Class II
EU: Class IIa
TGA: Class IIa

Jurisdictions

🇺🇸

FDA USA

World's largest device market

🇪🇺

EU MDR

27-country single approval

🇦🇺

TGA Australia

APAC gateway via MDSAP

🇨🇦

Health Canada

MDSAP founding member

🇯🇵

PMDA Japan

🇨🇳

NMPA China

🇸🇬

HSA Singapore

🇰🇷

MFDS South Korea

🇮🇳

CDSCO India

🇧🇷

ANVISA Brazil

🇹🇭

Thai FDA

🇲🇾

MDA Malaysia

🇻🇳

Vietnam MOH

🇵🇭

Philippines FDA

🇭🇰

Hong Kong

10+

markets unlocked by a single FDA clearance

Reference Agency Recognition

See which approvals unlock faster pathways in other markets. Map your existing clearances to optimal market entry sequences.

Pathways & Guidance

Find Your Regulatory Pathway

Step-by-step guidance from classification to market approval

Core Tool

Pathway Finder

Answer a few questions about your device → get the exact submission route, timeline, and costs for every target market.

Start wizard

Guidance Library

Regulatory documents and reference material

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