By Device Class
Overview
The ARTG inclusion process varies significantly depending on the device class. Lower-risk devices have streamlined processes with minimal pre-market TGA review, while higher-risk devices involve more extensive assessment. The key differences are the type of manufacturer evidence required, whether the application is subject to mandatory audit, and the TGA's pre-market scrutiny of the device.
Class I (including Is and Im)
Process: Validation-based inclusion (low TGA review) Manufacturer evidence submitted with application: Declaration of Conformity (Class I); QMS certificate (Is/Im) Audit likelihood: Low (non-mandatory; may be selected for risk-based audit) Pre-market TGA assessment: Validation of application completeness; no detailed technical review unless audited
Class I applications are processed with the lowest regulatory burden. The TGA validates that the application is complete and the sponsor's declaration is consistent with the information provided, but does not conduct a detailed pre-market technical review unless the application is selected for audit.
Class IIa
Process: Inclusion based on accepted manufacturer evidence Manufacturer evidence accepted before application: ISO 13485 QMS certificate + Declaration of Conformity (+ comparable overseas regulator certificate where required) Audit likelihood: Moderate (risk-based selection criteria apply) Pre-market TGA assessment: Manufacturer evidence assessed; application reviewed at audit if selected
Manufacturer evidence must be submitted and accepted before the ARTG application is lodged. The TGA assesses whether the submitted evidence is from an accepted source and covers the relevant device scope.
Class IIb
Process: Inclusion based on accepted manufacturer evidence including product certificate Manufacturer evidence required: Full QMS certificate + Product-specific design certificate (EU MDR CE, TGA CAC, or accepted equivalent) Audit likelihood: Higher (more applications selected under risk-based criteria) Pre-market TGA assessment: More detailed at audit; product-specific evidence reviewed
For Class IIb, a product-specific certificate is required in addition to a QMS certificate. The product certificate must cover the specific device type being included.
Class III
Process: Full assessment for many applications; audit mandatory in certain cases Manufacturer evidence required: Full QMS certificate + comprehensive product design assessment Audit likelihood: High; mandatory audit for applications supported by EU MDD certificates or US 510(k) Pre-market TGA assessment: Most extensive; product design documentation reviewed at audit
Class III is subject to the highest pre-market regulatory scrutiny. Applications supported by EU MDR certificates from a notified body with an up-to-date designation and audit may avoid mandatory audit — check current TGA guidance. Annual reporting obligations apply for 3 years minimum after inclusion.
IVD Class 1
Process: Validation-based inclusion Manufacturer evidence: Declaration of Conformity submitted with application Audit likelihood: Low Notes: Similar to general Class I
IVD Class 2
Process: Inclusion based on accepted manufacturer evidence Manufacturer evidence: ISO 13485 certificate + Declaration of Conformity Audit likelihood: Moderate
IVD Class 3
Process: Full evidence assessment; mandatory audit in many cases Manufacturer evidence: QMS certificate + product-specific certificate (EU IVDR preferred) Audit likelihood: High; mandatory audit applies for many Class 3 applications Notes: Companion diagnostics and HIV self-tests have specific additional requirements
IVD Class 4
Process: Full pre-market assessment Manufacturer evidence: Full QMS + product design assessment Audit likelihood: Mandatory audit applies Notes: Highest pre-market scrutiny for IVDs; blood supply safety implications drive closer review