Medical devices: Sponsors
Sponsors take responsibility for the supply of a medical device in or from Australia. The sponsor's name and address may appear on the label.
If you have an enquiry about medical devices that is not answered by this website, please see the contact details for medical devices enquiries.
Getting things done
- What do I need to do to supply a medical device in Australia?
<http://www.tga.gov.au/devices/supplymd.htm> - How to...
- Get your medical device onto the ARTG
<http://www.tga.gov.au/devices/artg.htm> - Ensure your application is processed swiftly
<http://www.tga.gov.au/devices/howtoapp.htm>
- Get your medical device onto the ARTG
- Forms
<http://www.tga.gov.au/devices/forms.htm> - eBusiness: online applications
<http://www.tga.gov.au/online/deal.htm> - Regulatory affairs consultants
<http://www.tga.gov.au/docs/html/regafair.htm> - Certification needed
<http://www.tga.gov.au/devices/certification.htm> - Contact details for enquiries
<http://www.tga.gov.au/devices/contacts.htm>
Sponsor activities
- Post market obligations
<http://www.tga.gov.au/devices/postmarket.htm> - Import devices
<http://www.tga.gov.au/impexp/commercial.htm> - Export devices
<http://www.tga.gov.au/devices/export.htm> - Adverse event reporting
<http://www.tga.gov.au/docs/html/forms/iris_mdir.htm> - Recalled medical devices
<http://www.tga.gov.au/recalls/index.htm>
Regulatory framework
- What is a medical device?
<http://www.tga.gov.au/devices/whatis.htm> - A sponsor's roadmap to market
<http://www.tga.gov.au/devices/devroadmap/index.htm> - Guidelines & standards
<http://www.tga.gov.au/devices/guidelines.htm> - Medical device classification
<http://www.tga.gov.au/docs/html/devguid25.htm> - Terms & definitions
<http://www.tga.gov.au/web/glossary.htm> - TGA's role in regulation
<http://www.tga.gov.au/devices/tgarole.htm> - International agreements
<http://www.tga.gov.au/international/index.htm> - Legislation
<http://www.tga.gov.au/legis/index.htm>
Other information
- Labelling & packaging
<http://www.tga.gov.au/label/index.htm> - Medical devices committees
<http://www.tga.gov.au/committee/index.htm> - Obtaining information about regulatory changes
<http://www.tga.gov.au/devices/changes.htm> - Medical device industry associations
<http://www.tga.gov.au/devices/assoc.htm>