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Links

GOVERNMENT

European Commission – Medical devices:
ec.europa.eu/growth/sectors/medical-devices/index_en.htm

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

 

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