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

• 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

How to use the filters - 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