Medical Device & IVD Regulatory Consulting Across Global Markets
Navigate country-specific regulatory requirements with specialist-led market-entry strategies, submission documentation, quality and clinical evidence support, and lifecycle regulatory services.
Country and market pages
Each page covers the authority, classification, pathways, documentation, QMS, local representation, process, post-market duties and our services. Markets marked "on request" are supported through consultation.
North America
Middle East & Africa
- Saudi Arabia On request
- United Arab Emirates On request
- Egypt On request
- South Africa On request
From market selection to registrations you control
Market access work for established and emerging markets, delivered by one team so evidence, registrations and post-market duties stay consistent across countries.
Regulatory and QMS strategy
Market prioritisation and entry sequencing that reuses evidence and quality certifications across countries.
Device registration
Dossiers prepared, submitted and managed, with renewals and change notifications tracked for every market.
Local representation coordination
Help appointing and working with in-country representatives, structured so you keep control of your registrations.
Global vigilance and compliance
Incident reporting, field actions and post-market obligations managed across jurisdictions.
Software and AI devices
Market access for SaMD and AI-enabled devices, including cybersecurity and change-control expectations by market.
Regulatory intelligence
Monitoring of rule changes in your markets, with impact assessments for your portfolio.
Priority markets side by side
| Market | Authority | Device classes | Main routes | Quality system | Local role |
|---|
Many markets require a local legal role: an EU Authorised Representative, UK Responsible Person, Swiss CH-REP, US Agent, Japanese MAH or DMAH, Indian authorised agent, Australian sponsor, Singapore registrant, Korea License Holder or Brazilian Registration Holder. Where MedoQi does not hold that role, we work with your appointed representative or a qualified partner. Our advisory coverage is distinct from in-country representation.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.