Links: Particular topics

CE marking - IVDD

CE marking

• Department of Health: -UK- Guidance for Business on Regulation
• MDA - Device Bulletins - medical device bulletins from the UK Medical Device Agency (MDA)
• SOS - Swedish health authority - Medical devices - CE-marking
• New Approach - EC Commission New Approch
  

In Vitro Diagnostic Directive (IVDD)

• Association of Medical Diagnostic Manufactures -- AMDM
• cdrh-ivd (fda - usa)
• edma-ivd.be (European Diagnostic Manufacturers Association)
• VDGH Verband der Diagnostica-Industrie e.V.
• BIVDA - British In Vitro Diagnostic Association.
  

Mutual Recognition Agreements (MRAs)

USA-EU

• MRA between the United States of America and the European Union
  • http://www.fda.gov/cdrh/modact/uerma.pdf
  • http://www.fda.gov/cdrh/fedregin.html
• SUMMARY of the FDA-Related Elements of the "Agreement on Mutual Recognition Between the United States of America and the European Community"
  • http://www.fda.gov/oia/mrasum.htm
• U.S. Food and Drug Administration Import Information
  • http://www.fda.gov/ora/import/ora_import_program.html
• U.S. Customs Service
  • http://www.customs.ustreas.gov/imp-exp1/index.htm

Canada-EU

• Guidance documents on medical devices
  • http://hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/guidmd.htm

Australia-EU

• MRA between Australia and the European Union
  • http://www.health.gov.au:80/tga/devices/devices.htm#mutual
    
    
    

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Last updated: 2010-04-22

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