Links
GOVERNMENT
European Commission – Medical devices:
ec.europa.eu/growth/sectors/medical-devices/index_en.htm
European Commission – Harmonized Standards
https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en
New Approach Notified and Designated Organisations (NANDO):
https://ec.europa.eu/growth/tools-databases/nando/index.cfm
United Kingdom:
www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
United States Center for Devices and Radiological Health:
www.fda.gov/cdrh
Japan Pharmaceuticals and Medical Devices Agency:
www.pmda.go.jp/english/index.html
INTERNATIONAL HARMONIZATION ORGANIZATIONS
International Medical Device Regulators Forum (IMDRF)
www.imdrf.org
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use:
www.ich.org
STANDARDS ORGANIZATIONS
Amercian National Standards Institute (ANSI):
www.ansi.org
American Society for Testing & Materials (ASTM):
www.astm.org
European Committee for Standardization (CEN):
www.cenorm.be
European Committee for Electrotechnical Standardization (CENELEC):
www.cenelec.org
International Electrotechnical Commission (IEC):
www.iec.ch
International Standardization Organization (ISO):
www.iso.org
ASSOCIATIONS
Association of British HealthTech Industries (ABHI):
https://www.abhi.org.uk
AdvaMed:
www.advamed.org
Association for the Advancement of Medical Instrumentation:
www.aami.org
Association for Clinical Research Professionals:
www.acrpnet.org
Association of Medical Diagnostics Manufacturers:
www.amdm.org
COCIR:
https://www.cocir.org
European Association of Authorised Representatives (EAAR):
www.eaarmed.org
Medical Device Manufacturers Association (MDMA):
www.medicaldevices.org
MedTech Europe:
https://www.medtecheurope.org
Regulatory Affairs Professional Society (RAPS):
www.raps.org
Team NB:
https://www.team-nb.org
Team PRRC:
https://www.team-prrc.eu
