Mandatory Application Audit for Medical Devices and IVDs in Australia

1. Key takeaways

Holding European CE certificates does not exempt an application from the mandatory application audit. The exemption list in clause 5.3 is exhaustive: only notified body certificates issued under the EU MDR or IVDR fall within the exemption (clause 5.3(2AA)). Certificates under the old MDD, AIMDD or IVDD directives, a standalone MDSAP certificate, and FDA 510(k) substantial equivalence determinations all remain subject to the mandatory audit and the audit fee. Reading the clause literally, layer by layer, is therefore not optional — it is the only reliable way to predict whether the audit and its fee will apply to a given application.

• The mandatory audit scope under clause 5.3(1) covers Class III devices, and Class 3 IVDs, Class 4 IVDs, Class 4 in-house IVDs, self-testing IVDs and point-of-care testing (POCT) IVDs.
• That scope was inserted by the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 (F2024L00686, registered 14 June 2024, Schedule 2 items 3–10) and applies from 1 July 2024.
• Exemptions operate at three layers: clause (2) for in-force TGA or Australian assessing body certificates, clause (2AA) for European MDR or IVDR certificates, and clause (2AB) for Health Canada licences, FDA PMA approval orders, Japanese approvals or certifications, Singapore HSA entries and certificates under mutual recognition agreements.
• Section 41FK causes the application to lapse if no response is given within 10 working days after the notice period expires, including where the audit fee has not been paid.
• Applications not subject to the mandatory audit may still be selected (section 41FH(1)(b)), and the TGA expressly states that no assessment fee is charged for non-mandatory audits.

2. Legal basis

Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the mandatory audit scope appears in clause 5.3(1) — Class III devices; Class 3 IVDs, Class 4 IVDs, Class 4 in-house IVDs, self-testing IVDs and point-of-care testing (POCT) IVDs. That scope was written in by the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 (F2024L00686, registered 14 June 2024, Schedule 2 items 3–10) and applies from 1 July 2024.

The upstream authorising provisions are section 41FH(1)(a) of the Therapeutic Goods Act 1989 (an application prescribed by the regulations must be selected for audit) and section 41FH(1A) (applicable to applications that have passed the preliminary evaluation under section 41FDB(3)).

Exemption provisions (clause 5.3): clause (2) covers an in-force TGA conformity assessment certificate or Australian assessing body certificate that has not been suspended or cancelled; clause (2AA) covers certificates issued by European notified bodies under the MDR (2017/745) or IVDR (2017/746); clause (2AB) covers Health Canada device licences, FDA PMA approval orders, Japanese MHLW or PMDA premarket approvals or certifications, Singapore HSA register entries, and certificates issued under the Australia–United Kingdom, EC or EFTA mutual recognition agreements.

Consequence provisions: sections 41FI(2) and (3) of the Therapeutic Goods Act 1989 (where the Secretary considers during the audit that the requirements are not satisfied, the Secretary must decide not to include the device); section 41FJ (written notice of the decision within 20 working days, with reasons where the decision is not to include); and section 41FK (the application lapses if no response is given within 10 working days after the notice period expires, including cases where the audit fee has not been paid).

Applications not subject to the mandatory audit may still be selected (section 41FH(1)(b)); the TGA expressly states that no assessment fee is charged for non-mandatory audits. The practical consequence is that even a product outside the mandatory scope should be documented as though an audit could be requested, because selection remains possible at any time.

3. Expert insights

Insight 1: the amendment of 1 July 2024 narrowed and focused the scope. After the amendment, the mandatory audit scope is simplified to Class III devices and a defined group of IVDs, removing categories such as device disinfectants and contraceptive devices that were previously subject to mandatory audit. This reduces the burden for low and medium-risk products, while raising the audit probability for high-risk products.

Insight 2: the three layers of the exemption list must be checked layer by layer. Layer (2) looks at TGA or Australian assessing body certificates, layer (2AA) at European MDR or IVDR certificates, and layer (2AB) at Health Canada licences, FDA PMA approval orders, Japanese approvals, Singapore entries and MRA certificates. An FDA 510(k) and a standalone MDSAP certificate fall within none of the layers — which directly determines whether the audit fee arises.

Insight 3: the lapse provision is more common than refusal. In practice, lapse of the application under section 41FK (no response within 10 working days) occurs more often than substantive refusal under section 41FI, because it depends only on the response deadline. Calendar management after receiving a TGA request for further information is the key control point of the audit stage.

4. Practical recommendations

• At project initiation, run a mandatory audit determination: classification, whether the product falls within clause 5.3(1), and whether it falls within the three exemption layers — three steps to a conclusion.
• For projects within the mandatory audit, build the audit fee and the audit timeline into the budget and schedule; the payment deadline appears in regulation 9.2 (28 days after notice).
• After receiving a TGA request for further information, immediately start a 10-working-day response countdown and assign a single accountable owner.
• Companies holding old-directive CE certificates should assess the cost of transitioning to MDR or IVDR certificates, and compare it with the cost of each mandatory audit before deciding.

5. Verification checklist

• □ Whether the product falls within the clause 5.3(1) mandatory audit scope has been determined
• □ Exemptions under clauses 5.3(2), (2AA) and (2AB) have been checked layer by layer
• □ It is confirmed whether the certificate held is an MDR or IVDR certificate or an old-directive certificate
• □ The audit fee and timeline are built into the budget and schedule
• □ A 10-working-day response countdown is in place for TGA requests for further information

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team prepares TGA-compliant CTOs and evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com