In Vitro Device (IVD) registration in Australia

In Vitro Device (IVD) registration in Australia

The Australian TGA regulates In Vitro Devices (IVDs) as a subset of medical devices, using a risk-based approach. Their regulatory framework aligns with the recommendations of the old Global Harmonisation Task Force (GHTF), or the new IMDRF. This means that if you successfully achieve an In Vitro Device (IVD) registration in Australia from the TGA then you are likely to achieve registration in other countries that align their regulations with the IMDRF.

Current IMDRF members as of June 2023 –

  1. Australia
  2. Brazil
  3. Canada
  4. China
  5. European Union
  6. Japan
  7. Russia
  8. Singapore
  9. South Korea
  10. United Kingdom
  11. United States of America.

In Vitro Diagnostic (IVD) Classification

IVDs are classified by the TGA as follows:

ClassificationLevel of risk
Class 1 IVDno public health risk or low personal risk
Class 2 IVDlow public health risk or moderate personal risk
Class 3 IVDmoderate public health risk or high personal risk
Class 4 IVDhigh public health risk

The same classification rules apply to both commercial IVDs and in-house IVDs.

Product Registration Services

PharmOut offers product registration services for companies wishing to register IVDs with the Australian TGA, and distribute within Australia. We can provide advice on product development, preclinical and clinical research, regulatory affairs and quality assurance.

Our regulatory affairs consultants can advise on:

  • CE marking of IVDs
  • IVD product classification – which classification does it fall into?
  • Preparation of technical files
  • Risk assessments
  • Quality audits

R&D Programs for Novel Products

PharmOut can assist with planning R&D programs for novel products; designing suitable studies to meet regulatory requirements and achieving timely approvals in target countries.

Our auditors can undertake cGMP, QSR, ISO 9000, ISO 13485 audits of companies, their suppliers and subcontractors, ensuring that appropriate standards of quality are met.

CE Marking of IVDs

IVD registration in the European Union is now harmonised and products bearing the CE mark can be freely marketed in all member states.

CE marking is an important step in getting your IVD product ready to market. First you must determine which category your product falls into – you can then determine which legislation applies, and what the best route to market will be.

Our team can advise on regulatory, scientific and quality matters, including ISO 13485, FDA QSR 820 and related standards.

More Information:

If you would like a quote or would need to ask questions, please contact us. This white paper on How to register an In-Vitro Diagnostic Device in Australia may be of interest.

Further Reading: