Guidance for medical device sponsors
- How to get a product on the ARTG/How to make an application through DEAL
<http://www.tga.gov.au/devices/dealfaq.htm> - Obligations and responsibilities of medical device sponsors and manufacturers
<http://www.tga.gov.au/docs/html/devguid20.htm> - Class 1 medical devices
<http://www.tga.gov.au/devices/fs_class1.htm> - Clinical evidence requirements for medical devices
<http://www.tga.gov.au/devices/clinicalev.htm> - Reasons for rejection of applications for medical devices
<http://www.tga.gov.au/devices/rejection.htm> - Transition of listed and registered devices
<http://www.tga.gov.au/devices/fs_transitn.htm> - Manufacturers' evidence - EC certificates for medical devices
<http://www.tga.gov.au/devices/fs_eccert.htm> - Application audits
<http://www.tga.gov.au/docs/html/devguid2.htm> - Abridged assessments for medical devices previously registered or listed in the Australian Register of Therapeutic Goods (ARTG)
<http://www.tga.gov.au/devices/abridged-assess.htm> - Application audit assessment documentation checklists
<http://www.tga.gov.au/devices/audit-cklst.htm> - Information deficiencies in applications requiring audit
<http://www.tga.gov.au/devices/info-deficiencies.htm> - Pre-submission meetings for medical device conformity assessment
<http://www.tga.gov.au/devices/presubmission.htm> - Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 - Information about Sponsor
<http://www.tga.gov.au/devices/mdregamend.htm
Related information
- Information for manufacturers of therapeutic goods
<http://www.tga.gov.au/manuf/index.htm>