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TGA Certification

Overview​

A TGA Conformity Assessment Certificate is a certificate issued by the TGA confirming that a manufacturer's quality management system and/or device design meets the requirements of the applicable conformity assessment procedures in Schedule 3 of the MD Regulations. TGA certification was historically required for certain high-risk device types where overseas regulator evidence was not accepted, but the scope of mandatory TGA certification has been significantly reduced since 2021. Manufacturers may still choose TGA certification voluntarily, particularly Australian manufacturers supplying the domestic market.

When is TGA Certification Required or Appropriate?​

Mandatory TGA certification is no longer required for most device types, following amendments in 2021 and 2024 that expanded acceptance of comparable overseas regulator evidence. However, TGA certification remains appropriate in the following situations:

  • Australian manufacturers who do not hold overseas regulatory approvals and are supplying primarily in Australia
  • Manufacturers seeking abridgement of TGA assessment, where overseas audit reports are submitted to reduce the TGA's assessment scope
  • Manufacturers of certain high-risk IVDs where specific TGA requirements apply (check current guidance as this is an evolving area)
  • Manufacturers who prefer TGA certification as their primary evidence pathway

The TGA Certification Process​

Step 1 — Application submission The manufacturer (not the sponsor) applies to the TGA for conformity assessment certification. The application must include:

  • Completed application form
  • Scope of certification requested (which parts of Schedule 3 and which device types)
  • QMS documentation and/or product design documentation depending on the parts sought
  • Overseas audit reports if requesting abridgement
  • Application fee payment

Step 2 — Preliminary assessment The TGA reviews the application to confirm it is complete and meets minimum requirements for assessment to proceed.

Step 3 — Assessment The TGA assesses the manufacturer's QMS (which may involve an on-site audit or desk-based assessment depending on the circumstances) and, for product certificates, reviews the device design documentation. Where the manufacturer has provided overseas audit reports, the TGA may conduct an abridged assessment.

Step 4 — Certification If the assessment is satisfactory, the TGA issues a Conformity Assessment Certificate. Certificates are time-limited and must be renewed.

Australian Conformity Assessment Bodies (CABs)​

Since 2021, Australian-based Conformity Assessment Bodies (CABs) can apply to the TGA to be approved to issue conformity assessment certificates for medical devices. An Australian CAB-issued certificate is accepted by the TGA in the same way as a TGA-issued certificate. This creates a new domestic certification pathway separate from both TGA direct assessment and overseas regulator reliance.

👉 Australian CABs — TGA

Timeframes​

TGA conformity assessment certification is a separate process from ARTG inclusion and takes additional time. The TGA publishes processing timeframe statistics in its performance reports. These vary depending on:

  • Whether an on-site audit is required
  • The volume of documentation submitted
  • Whether abridgement is claimed
  • Responsiveness to any TGA requests for additional information

👉 Processing timeframes — TGA

Fees​

TGA conformity assessment fees apply and vary based on the conformity assessment procedure and scope. Current fees are published in Schedule 5 of the MD Regulations and in the TGA's annual fees and charges summary.

👉 Fees and charges summary — TGA

Official Sources​