Manufacturer Evidence for Australian Medical Device Registration

1. Key takeaways

“Manufacturer evidence” is not a single document but a portfolio of documents issued by recognised bodies. This means the practical task is not to collect any single document, but to assemble a recognised portfolio that matches the class. The Determination does not define the term “manufacturer evidence”; in practice it is controlled through the definitions in section 4 and through the schedules, which list the acceptable forms item by item. Taking Class III as an example, the acceptable forms span multiple pathways, including TGA certificates, European notified body certificates, Health Canada licences, FDA approvals, Japanese approvals, Singapore entries and United Kingdom certificates, and each pathway shapes the combination of documents differently.

• The term is controlled through the section 4 definitions and the schedule requirements rather than through any standalone definition.
• For Class III devices, Schedule 1 Part 4 items 1 to 17 set out the acceptable forms of evidence.
• An MDSAP certificate is defined as one issued after a quality management system audit completed by an auditing organisation recognised or authorised by the governing committee of the MDSAP Regulatory Authorities, whose members include the TGA, the United States FDA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and the PMDA.
• The list of comparable overseas regulators is at agency level, so the issuing body of every certificate must be verified individually.
• On the TGA certificate pathway for Class III, only one certificate is needed, but the design examination excluded under clause 1.6 must be handled separately as its own step.

2. Legal basis

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (F2018L01410, compilation version 13, effective 1 December 2025): the definitions appear in section 4, where conformity assessment certificate, document and procedures draw on section 3 of the Therapeutic Goods Act 1989. An MDSAP certificate is defined as a certificate issued after a quality management system audit has been completed by an auditing organisation, defined as an organisation recognised by the governing committee of the MDSAP Regulatory Authorities, whose members include the TGA, the United States FDA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and the PMDA.

Acceptable forms for Class III (Schedule 1 Part 4 items 1–17, selected): a conformity assessment certificate issued by the TGA under the Therapeutic Goods Act 1989 covering the full quality system of Schedule 3 Part 1, excluding clause 1.6, clause 1.6 being design examination; a certificate issued by a European notified body under section 3 of Annex II of 93/42/EEC together with section 4 of Annex II (design examination); a certificate issued under section 3 of Annex 2 of 90/385/EEC together with section 4; a European MDR Annex IX Chapter I quality management system certificate together with a Chapter II technical documentation assessment certificate; a Health Canada MDSAP certificate together with a Class IV device licence; a United States FDA MDSAP certificate together with a 510(k) substantial equivalence determination or a PMA approval order; a Japanese MHLW or PMDA quality management system certificate together with premarket approval; a Singapore HSA Class D entry; and the corresponding United Kingdom approved body certificate (from 2025).

The list of comparable overseas regulators recognised by the TGA (TGA guidance Using assessments from comparable overseas regulators for medical devices, dated 11 May 2026) comprises notified bodies designated by European Union member states, the United States FDA, Health Canada, MDSAP auditing organisations, Japan’s MHLW and PMDA, Singapore’s HSA, and approved bodies designated by the United Kingdom MHRA.

3. Expert insights

Insight 1: the “system plus product” combination takes a different shape on each pathway. The TGA certificate pathway requires only one certificate, with the exclusion of clause 1.6 design examination handled separately; the European MDR pathway requires two documents, namely Annex IX Chapter I plus Chapter II; and the Health Canada and FDA pathways both require an MDSAP certificate paired with a product-side document. Assuming that a single MDSAP certificate suffices for everything is the most common mismatch.

Insight 2: Class III devices and Class 4 IVDs are singled out for design examination. The design examination in Schedule 3 Part 1 clause 1.6 applies only to Class III devices, Class 4 IVDs and Class 4 in-house IVDs. This means that for a Class III device on the TGA certificate pathway, design examination is a separate step that cannot be covered by the quality system certificate.

Insight 3: the list is at agency level, so the issuing body must be checked certificate by certificate. Certificates issued by the same corporate group in different countries are usable only where the issuing body falls within the recognised bodies. The issuing body name and certificate number are verified individually at the evidence-gathering stage, rather than judged broadly on the basis that “we hold CE certificates”, because a certificate that looks valid on its face may still fail this check.

4. Practical recommendations

• Perform the gap analysis in three steps: the inventory of certificates already held, the corresponding Schedule 1 Part 4 item numbers, and which column is missing.
• Where product-side evidence is missing, first assess whether a European MDR Annex IX Chapter II technical documentation assessment certificate can close the gap.
• For Class III projects, plan the timeline and cost of the design examination (Schedule 3 Part 1 clause 1.6) separately.
• Record in a certificate register the issuing body, certificate number, validity period and the covered Australian requirement wording of every certificate.

5. Verification checklist

• □ Acceptable forms have been checked item by item against Schedule 1 Part 4
• □ Both the system column and the product column have been confirmed as covered
• □ The issuing body of every certificate has been checked against the recognised body list
• □ Design examination under clause 1.6 has been planned for Class III projects
• □ The certificate register records numbers, validity periods and covered wording

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