Information for Medical Device Suppliers
Overseas Medical Device Regulators
Links to key medical device regulators from around the world.
Australian Therapeutic Goods Administration (TGA)
UK Medicines and Healthcare products Regulatory Agency (MHRA)
USA Food and Drug Administration (FDA)
Health Canada
Pharmaceuticals and Medical Device Agency (PMDA)
Global Harmonisation Task Force (GHTF)
Asian Harmonisation Working Party (AHWP)
Global Medical Device Nomenclature (GMDN) Agency
Australian Therapeutic Goods Administration
The TGA is the Australian federal regulator for therapeutic products.
External Link to TGA website at tga.gov.au
UK Medicines and Healthcare products Regulatory Agency
The MHRA is the UK's regulator for medicines and medical devices.
External Link to MHRA website at mhra.gov.uk
USA Food and Drug Administration
The US-FDA is the USA federal regulator for food, medicines, medical devices, and cosmetics.
External Link to US-FDA website at fda.gov
External Link to the US-FDA Centre for Devices
and Radiological Health (CDRH) at fda.gov
Health Canada
Health Canada is the Canadian federal regulator for therapeutic products.
External Link to Health Canada website at hc-sc.gc.ca
Pharmaceuticals and Medical Device Agency
The PMDA is the Japanese medical device regulator and is part of the Ministry of Health, Labour and Welfare.
External Link to PMDA website at pmda.go.jp
Global Harmonization Task Force (GHTF)
The GHTF is an association of key regulators working to develop ways to develop a common approach to the regulation of medical devices. The GHTF provides guidance to other regulators about best practice in all areas of medical device regulation.
External Link to GHTF website at ghtf.org
Asian Harmonisation Working Party
The AHWP is an association of Asian countries that are working to harmonise medical device regulation in coordination with the Global Harmonisation Task Force, the Asia Pacific Economic Community and other international organisations. AHWP is a liaison partner of the GHTF.
External Link to AHWP website at ahwp.info
Global Medical Device Nomenclature (GMDN) Agency
The GMDN Agency maintains the database of GMDN codes used to provide identifiers for types of medical devices.
External Link to GMDN Agency website at gmdnagency.org
Page last updated 10 May 2011