Regulations
Website Links
U.S. Food and Drug Administration (FDA)
www.fda.gov
Center for Devices and Radiological Health
www.fda.gov/medicaldevices
Device Advice: Comprehensive Regulatory Assistance
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
CDRHNew – News and Updates
www.fda.gov/MedicalDevices/NewsEvents/News/default.htm
Website Links
European Commission – Medical Devices
https://health.ec.europa.eu/medical-devices-sector/overview_en
Regulatory Framework – Medical Devices
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
MEDDEVs Guidance
https://health.ec.europa.eu/system/files/2022-01/md_guidance_meddevs_0.pdf
European Harmonized Standards – Medical Devices
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
MDCG Guidance Documents
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
Website Links
Central Drug Standard Control Organization
www.cdsco.gov.in
Bureau of Indian Standards
www.bis.gov.in
Medical Device SUGAM Portal
www.cdscomdonline.gov.in/NewMedDev/Homepage
Quality Council of India
www.qcin.org
Indian Council of Medical Research
www.icmr.gov.in
Clinical Trial Registry
www.ctri.nic.in
Association of Indian Medical Device Manufacturers
www.aimedindia.com
Website Links
Health Canada Medical Devices page
https://www.canada.ca/en/health-canada/services/drugs-health-products
Health Canada – MDSAP program
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international
Health Canada – Medical Devices Active Licence Listing (MDALL)
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences
Health Canada – List of Recognized Standards for Medical Devices
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards
Regulatory Documents
Website Links
Therapeutic Goods Administration (Australia)
www.tga.gov.au
National Health and Medical Research Council (Australia)
www.nhmrc.gov.au
Department of Health and Ageing – Prostheses List (Australia)
www.health.gov.au/internet/main/publishing.nsf/content/health-privatehealth-prostheseslist.htm
Medsafe (New Zealand)
www.medsafe.govt.nz
International Committee on Harmonization
www.ich.org/home.html
Medicare Benefits Schedule (Australia)
www.health.gov.au/internet/mbsonline/publishing.nsf/Content/Medicare-Benefits-Schedule-MBS-1