Regulatory guidelines & standards for medical devices

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Australian medical devices guidelines

There is currently a project underway to redevelop the guidelines to make them easier to understand and to use. For more details, please see: Development of Australian Regulatory Guidelines for Medical Devices (ARGMD)

1. An overview of the new medical devices regulatory system
   <http://www.tga.gov.au/docs/html/devguid1.htm>
2. Application audits
   <http://www.tga.gov.au/docs/html/devguid2.htm>
3. Conformity assessment procedures
   <http://www.tga.gov.au/docs/html/devguid3.htm>
4. Clinical evidence requirements for Inclusion of medical devices in the Australian Register of Therapeutic Goods
   <http://www.tga.gov.au/docs/html/devguid4.htm>
5. The declaration of conformity
   <http://www.tga.gov.au/docs/html/devguid5.htm>
7. The use of medical devices in alternative therapies
   <http://www.tga.gov.au/docs/html/devguid7.htm>
8. Advertising medical devices
   <http://www.tga.gov.au/docs/html/devguid8.htm>
9. Transitional arrangements for the introduction of the new medical devices regulatory system
   <http://www.tga.gov.au/docs/html/devguid9.htm>
11. Postmarket activities
    <http://www.tga.gov.au/docs/html/devguid11.htm>
12. Conditions on conformity assessment certificates issued by the Therapeutic Goods Administration
    <http://www.tga.gov.au/docs/html/devguid12.htm>
13. Variants for Class III and AIMD medical devices
    <http://www.tga.gov.au/docs/html/devguid13.htm>
14. Requirements for the assessment of medical devices containing animal material, with particular regard to the minimisation of risks relating to transmitting Transmissible Spongiform Encephalopathies (TSEs)
    <http://www.tga.gov.au/docs/html/devguid14.htm>
20. Obligations and responsibilities of medical device sponsors and manufacturers
    <http://www.tga.gov.au/docs/html/devguid20.htm>
22. The essential principles for medical devices
    <http://www.tga.gov.au/docs/html/devguid22.htm>
25. Classification of medical devices
    <http://www.tga.gov.au/docs/html/devguid25.htm>
26. 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>
35. Device-medicine boundary products
    <http://www.tga.gov.au/docs/html/devguid35.htm>

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