Links
USA
FDA website
FDA Medical device Overview
FDA_Medical devices databases
Direct Access to Code of Federal Regulations
ASTM (American Society for Testing and Materials)
BRAZIL
ANVISA Regulation of companies list of Good Manufacturing Practices
ANVISA Regulation of medical devices
CANADA
Canadian Medical devices What’s new ?
Canadian Medical devices regulation SOR 98/282
AUSTRALIA
Australian TGA website
Medical device regulation basics
Standards, guidelines and publications
EUROPE
European website
European Medical devices sector
European TEAM-NB organization
Competent Authorities for Medical Devices Group
List of bodies notified for regulation 2017/745
List of bodies notified for regulation 2017/746
European MD Harmonised standards
European IVD Harmonised standards
European AIMD Harmonized Standards
Direct access to MDR 2017/745
Direct access to IVDR 2017/746
List of MEDDEV Guidances
FRANCE
ANSM Agence National de Sécurité du Médicament et des dispositifs médicaux
Code de la santé publique
Le Journal Officiel
Legifrance
Haute Autorité de santé
AFNOR
Accès à la base AMELI - LPP
USA
FDA website http://www.fda.gov
FDA Medical device Overview https://www.fda.gov/medical-devices
FDA_Medical devices databases :
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
Direct Access to Code of Federal Regulations : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
ASTM (American Society for Testing and Materials)
CANADA
Canadian Medical devices What’s new ? https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html
Canadian Medical devices regulation SOR 98/282 https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/
AUSTRALIA
Australian TGA website http://www.tga.gov.au
Medical device regulation basics
https://www.tga.gov.au/medical-devices-regulation-basics
Standards, guidelines and publications
https://www.tga.gov.au/standards-guidelines-publications-medical-devices-ivds
JAPAN
Pharmaceutical and Medical Device Agency PMDA https://www.pmda.go.jp/english/
