Information / Links

Apart from the member countries of the EC, the routes to market can vary widely from country to country . 
In general terms the time, costs, data collation, compliance evidence and resources necessary to attain regulatory approvals tend to be by-passed in business, product development and marketing plans. 
We have included indicative steps to market in EC, US,  and Canada. Please call for assistance for any other country e.g. Japan and China.

• EC Directives
   

  • Active Implantable Medical Devices (AIMDD)
    - Directive 90/385/EEC 
    
    

  • Medical Devices Directive (MDD) 
    - Directive 93/42/EEC

    - Directive 2007/47/EC
    
    

  • In Vitro Diagnostic Directive (IVDD) 
    - Directive 98/79/EC

  http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

• EC Guidance

  • EC Guidelines relating to Medical Device Directives
  • EC Harmonised Standards for Medical Devices
  • Does the Machinery Directive apply to your device? (EC Interpretation)
  • Does the Personal Protective Equipment Directive apply to your device? (EC Interpretation)
     
• UK Guidance

  • Guidelines prepared by the UK Competent Authority( MHRA) 
     

• US Guidance

  • Guidance from the FDA 
     

    • Industry Assistance
    • Software Validation
    • Design Control Guidance
    • Good Manufacturing Practice/Quality Systems
    • In Vitro Diagnostic Device Evaluation and Safety
    • Device Advice
    • Device Listing
    • Establishment Registration
    • Workshops and Conferences
    • Advisory Meetings
    • Medical Device Reporting
    • Medical Device Databases
    • Forms
    • Recognised Standards
    • Contact the Center for Devices and Radiological Health
• Canadian Guidance
  • Guidance from Health Canada
     
• Australian Guidance
  • Guidance from Therapeutic Goods Administration (TGA) 
     
• China Guidance
  • Guidance from the State Food & Drug Administration (SFDA)