Your complete market access overview: now with MDSAP and CE filters
Moving beyond myths to facts: Our interactive Regulatory World Map now helps you explore exact market requirements for 20+ countries – filtered by what matters to your strategy.
What’s new:
- MDSAP status filtering: Distinguish between Member, Official Observer, and Affiliate countries
- CE acknowledgement filter: Identify markets that recognise CE marking
- Country-specific intelligence: Click any country for detailed access requirements
What you’ll find for each market:
When you select a country, get instant access to:
- Applicable regulations: the specific laws governing your device
- Risk classification system: how your device will be classified
- Assessment routes: pathways to market approval
- Registration timelines: realistic duration estimates
- Competent authority: responsible healthcare regulator with direct links
- MDSAP participation level: Member, Observer, or Affiliate status
- Mutual recognition agreements: collaboration frameworks
- Labelling requirements: language and content specifications
- Foreign manufacturer rules: local representation and responsibilities
- Validity duration: how long your approval lasts
- QMS requirements: quality system expectations
How to use the filters:
For EU manufacturers expanding globally:
- Filter by CE acknowledgement to find markets that recognise your existing certification
- Review MDSAP status to plan your audit strategy
- Check individual country requirements for the complete picture
For manufacturers planning MDSAP:
- Filter by MDSAP Member to see full programme participants
- Compare with Official Observer markets for future opportunities
- Assess where single audit delivers maximum market access
For strategic market selection:
- Compare registration timelines across target markets
- Review QMS requirements for resource planning
- Check validity durations for renewal planning
Your market access roadmap starts here:
Visit EUMEDIQ Regulatory World Map to explore detailed requirements for:
- United States & Canada (MDSAP Members)
- European Union countries (CE markets)
- Australia, Brazil, Japan (MDSAP Members)
- ASEAN countries & emerging markets
- Middle East & Latin America
Stop working from assumptions. Start planning with precise, country-specific intelligence. Our World Map transforms complexity into clarity – helping you make informed decisions about where and how to expand globally.