Australia 2024 Update: Market Authorization for Medical Devices

An update to Australia’s guidance on the use of market authorization evidence from overseas regulators for medical devices, including in-vitro diagnostic devices (IVDs), was released yesterday. This update aims to streamline the process for including devices and IVDs in the Australian Register of Therapeutic Goods (ARTG).

Key Updates to Australia Market Authorization for Medical Devices

The updated guidance incorporates amendments to reflect changes to Regulation 5.3, effective July 1, 2024, and the TGA’s strategy for managing further extensions to the EU IVDR transition timelines. The following key updates are now included in the guidance:

1. Class 4 IVDs: To leverage the IVDD 98/79/EC approval for Class 4 IVDs, sponsors must now provide evidence that the manufacturer meets the EU IVDR extension eligibility conditions.

2. Expanded Regulators/Approvals for Class 4 IVDs: The list of acceptable overseas regulatory approvals for Class 4 IVDs has been expanded to include:

• • FDA: Premarket approval under Section 515 of the US FDC Act
  • Health Canada: MDSAP Certificate
  • Singapore: An extract from the Singapore Register of Health Products as a Class D IVD
  • PMDA (Japan): MDSAP Certificate or QMS certificate from the Pharmaceuticals and Medical Devices Agency (PMDA)

These updates are part of Australia’s ongoing efforts to enhance the efficiency and flexibility of the regulatory pathway for medical devices and IVDs, ensuring alignment with global standards while addressing local regulatory requirements.

For further details, applicants are encouraged to consult the updated guidance and review the eligibility conditions for each of the regulatory approvals listed above.

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