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1. Australian Regulatory Guidelines for Medical Devices(ARGMD) (2011)

2. IVD guidance document

2.1   Application audit (technical file review) of IVD medical device applications (2011)

2.2   Conformity assessment overview (2011)

2.3 Business rules for reduced assessment fees for IVDS(2012)

2.4 Classification of IVD medical devices(2011)

2.5 Conformity assessment procedures ofr immunohaematology reagents(2012)

2.6 Fees and charges for IVD medical devices(2010)

2.7 Including IVD medical devices in the ARTG(2010)

2.8 Regulatory requirements for in-house IVDs in Australia(2012)

2.9 Software as in vitro diagnostic medical devices(IVDs)(2013)

2.10 The use of GMDN codes for IVD medical devices in Australia(2010)

2.11 What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs(2011)

2.12 What a sponsor needs to know about conformity assessment and manufacturer’s evidence for IVDs(2011)

3. Medical Device Standards Order

3.1 Medical device standards order( standards for biological safety of medical devices) 2008

3.2 Medical device standards order (standards for clinical evidence) 2008

3.3 Medical device standards order (standards for medical devices required to be sterile) 2008

3.4 Medical device standards order (standards for natural latex rubber condoms) 2008

3.5 Medical device standards order ( standards for risk management) 2008

4. Reduction of assessment fees for medical devices(2015)

5. Declaration of conformity templates(medical device) (2013)

6. Declaration of conformity templates (IVDs)

7. TGA labelling and packaging regulatory framework(2011)

8. Advertising therapeutic goods

9.  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)

10.  Essential principles check list (medical device)

11.  Device-medicine boundary products  (2005)