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Checklist & Compliance

Overview​

Demonstrating compliance with the Essential Principles requires systematic documentation. The manufacturer must identify which EPs apply to their device, gather and assess evidence of compliance for each applicable EP, and compile this into a structured format — typically as part of their technical file. The TGA publishes a standard Essential Principles Checklist template that is expected in most ARTG applications and is a practical starting point for documenting compliance.

The TGA Essential Principles Checklist​

The TGA publishes a checklist template that maps each Essential Principle to the evidence a manufacturer should hold. The template is updated periodically — always use the most current version, available on the TGA website.

👉 Download the Essential Principles Checklist template — TGA

For each EP, the checklist typically requires the manufacturer to state:

  • Whether the principle applies to the device
  • If not applicable, the justification
  • If applicable, the evidence held (standards applied, test reports, clinical evidence)
  • The section of the technical file where this evidence can be found

Compliance Methods​

Using Harmonised Standards​

Compliance with a relevant Australian or international standard provides the strongest presumption of compliance with the corresponding Essential Principle. Manufacturers should:

  1. Identify all applicable standards for the device type
  2. Apply the current edition of each standard
  3. Document any deviations from standard requirements and justify why compliance with the EP is still achieved

Standards commonly cited in Australian EP checklists include:

StandardRelevant EPs
ISO 14971EP 1, 2
IEC 60601-1EP 9, 12
IEC 62304EP 12.1
ISO 10993 seriesEP 7
ISO 11607EP 8
ISO 13485QMS (supports all EPs)

Alternative Methods​

If a harmonised standard does not exist or does not fully address a specific EP, manufacturers may demonstrate compliance through:

  • Custom testing and validation protocols
  • Expert opinions
  • Literature review
  • Post-market surveillance data

Any alternative approach must still demonstrate that the EP's underlying intent is met.

What the TGA Looks For During an Audit​

During an ARTG application audit, TGA auditors review the EP checklist and supporting evidence. Common issues that cause audit delays or failures include:

  • Using outdated standards — the edition of the standard must be current at the time of application or the deviation must be justified
  • Missing EP applicability justifications — simply marking an EP as "N/A" without explanation is insufficient
  • Gaps between the checklist and the technical file — the checklist references documents that are not actually in the technical file
  • Incomplete biocompatibility assessment — for patient-contacting devices, a biological safety evaluation report (BSER) following ISO 10993-1 is expected
  • Inadequate clinical evidence — the level of clinical evidence must be proportionate to the device class and novelty

Maintaining Compliance Over Time​

EP compliance is a dynamic obligation. When any of the following occur, the EP assessment must be reviewed and updated:

  • Design changes to the device
  • Material changes (suppliers, specifications)
  • Manufacturing process changes
  • New post-market safety data
  • Updates to applicable standards

Changes that affect EP compliance must be reflected in updated technical documentation and may require notification to the TGA or a new ARTG application depending on whether the change is "significant."

Official Sources​