Guidance for medical device manufacturers
- Obligations and responsibilities of medical device sponsors and manufacturers
<http://www.tga.gov.au/docs/html/devguid20.htm> - How to apply for a conformity assessment certificate and/or an EC certificate of conformity under the EU-Australia MRA
<http://www.tga.gov.au/docs/html/devguid26.htm> - The declaration of conformity
<http://www.tga.gov.au/docs/html/devguid5.htm> - Conditions on conformity assessment certificates issued by the Therapeutic Goods Administration
<http://www.tga.gov.au/docs/html/devguid12.htm> - Clinical evidence requirements for medical devices (summary)
<http://www.tga.gov.au/devices/clinicalev.htm> - Clinical evidence requirements for inclusion of medical devices in the Australian Register of Therapeutic Goods (guidelines)
<http://www.tga.gov.au/docs/html/devguid4.htm> - The use of GMDN codes according to the Australian regulatory system
<http://www.tga.gov.au/devices/fs_gmdn.htm> - Manufacturers of Class 1 medical devices
<http://www.tga.gov.au/devices/fs_class1man.htm> - Re-manufacturing single use devices (information for manufacturers)
<http://www.tga.gov.au/devices/fs_sudman.htm> - Pre-submission meetings for medical device conformity assessment
<http://www.tga.gov.au/devices/presubmission.htm> - Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007
<http://www.tga.gov.au/legis/mp0701.htm>
Related information
- Information for manufacturers of therapeutic goods
<http://www.tga.gov.au/manuf/index.htm>