Medical devices: Manufacturers
Manufacturers take full responsibility for the design and production of a medical device whether they make the device themselves or subcontract some of these activities. The name and address of the manufacturer always appears on the device 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
- Where to start
<http://www.tga.gov.au/devices/manufstart.htm> - Certification needed
<http://www.tga.gov.au/devices/certification.htm> - How to ensure your application is processed swiftly
<http://www.tga.gov.au/devices/howtoapp.htm> - 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> - Contact details for enquiries
<http://www.tga.gov.au/devices/contacts.htm>
Post market obligations
- Post market obligations
<http://www.tga.gov.au/devices/postmarket.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>
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> - Glossary of 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> - Fit and proper persons requirements
<http://www.tga.gov.au/manuf/fpp.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>