Quality Management Systems and ISO 13485 in Australia

1. Key takeaways

The statutory vehicle for Australian medical device quality management systems is the CASO 2019 (registered as F2019L00426), an “optional” conformity assessment standard: conformity with the standards listed in its Schedule 1 is deemed to satisfy the application of the corresponding conformity assessment procedures. The core standard is ISO 13485:2016. The optional character of the instrument is what gives manufacturers flexibility, but it also means the deemed effect must be understood precisely, since it attaches only to the standards and variants actually listed in the schedules.

• Sections 5(2) and (3): conformity with the standards listed in Schedule 1 is deemed to constitute application of the corresponding conformity assessment procedures.
• Schedule 1 is ISO 13485:2016 with three variants, mapping respectively to Schedule 3 Part 1 clause 1.4, Part 4 clause 4.4 and Part 5 of the Regulations.
• Regional or national adoptions deemed equivalent: EN ISO 13485:2016, ANSI/AAMI/ISO 13485:2016 and AS ISO 13485:2017 (TGA guidance on the CASO 2019, Version 1.0, June 2019).
• The Australian regime of a manufacturing licence plus overseas GMP certification does not apply to medical devices.
• The actual audit frequency and practice of the TGA toward the quality management systems of overseas manufacturers is not stated in quantitative terms on official pages (practical estimate); the current pathway relies on conformity assessment certificates, MDSAP certificates or ISO 13485 documentation rather than routine TGA on-site audits.

2. Legal basis

Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 (Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019), registered as F2019L00426; authorised by section 41DC of the Therapeutic Goods Act 1989; signed on 26 March 2019, registered and effective on 27 March 2019, with the full text applying from 31 March 2019.

It is positioned as an “optional conformity assessment standard”: sections 5(2) and (3) — conformity with the standards listed in Schedule 1 is deemed to constitute application of the corresponding conformity assessment procedures. The manufacturer may alternatively satisfy the procedures by other recognised means, but the deemed route is the one most certificates in circulation are built on.

Schedule 1 is ISO 13485:2016, with three variants corresponding respectively to Schedule 3 Part 1 clause 1.4, Part 4 clause 4.4 and Part 5 of the Therapeutic Goods (Medical Devices) Regulations 2002. The variant structure means the same parent standard supports several conformity assessment procedures, and the certificate itself must be read against the procedure it is being used to support.

Equivalent adoptions: the TGA states that regional or national adoptions of the parent standard ISO 13485:2016 are deemed to satisfy it equally, including EN ISO 13485:2016, ANSI/AAMI/ISO 13485:2016 and AS ISO 13485:2017 (TGA guidance on the CASO 2019, Version 1.0, June 2019). This recognition means the certificate held does not need to carry the ISO designation itself, provided the adoption is one of those expressly listed.

Regime that does not apply: Australia’s regime of a manufacturing licence plus overseas GMP certification does not apply to medical devices — the TGA guidance Australian manufacturing licences and overseas GMP certification states expressly that it is not directed at medical device manufacturers or sponsors. The guidance exists for pharmaceutical products, and its scope statement is the reason device sponsors cannot borrow from it.

Practical estimate: the actual audit frequency and practice of the TGA toward the quality management systems of overseas device manufacturers is not stated in quantitative terms on official pages (pending verification); the current pathway relies on conformity assessment certificates, MDSAP certificates or ISO 13485 documentation (see the tables of Schedules 1–3 of the Information Determination) rather than routine TGA on-site audits.

3. Expert insights

Insight 1: “deemed conformity” is a legal presumption, not an audit conclusion. The deemed mechanism in section 5(3) means that companies holding ISO 13485:2016 certificates need not separately prove conformity with the system clauses. It covers only the scope listed in Schedule 1, and anything beyond that scope still requires separate evidence, so the certificate should be read as covering a defined perimeter rather than every quality question the regulator might ask.

Insight 2: regional equivalent adoptions are expressly recognised. The EN, ANSI/AAMI and AS versions are deemed equivalent. This is an important relief point for companies holding certificates to the Chinese GB/T standard or to the three listed versions, but the certificate version year (2016 or 2017) must be checked, because the recognition attaches to those specific adoptions of the 2016 parent standard and not to any later revision.

Insight 3: device manufacturers are outside the GMP licensing regime. The pharmaceutical-side pathway of a manufacturing licence plus overseas GMP certification does not apply to devices. Teams often transplant pharmaceutical GMP experience and end up searching for a device GMP certificate that does not exist when preparing materials, wasting effort that should go into the evidence the Determination actually requires.

4. Practical recommendations

• Base system evidence on ISO 13485:2016 certificates or their recognised equivalent adoptions, and record the version year in the certificate register.
• Annotate in the Essential Principles checklist which portions are covered by the deemed conformity mechanism and which require separate evidence.
• For projects proceeding under Schedule 3 Part 1, Part 4 or Part 5, confirm which variant the certificate corresponds to (mapping respectively to 1.4, 4.4 and Part 5).
• Do not prepare materials according to the pharmaceutical GMP pathway; prepare them against the system column of the Information Determination tables instead.

5. Verification checklist

• □ An ISO 13485:2016 certificate or a recognised equivalent adoption has been confirmed
• □ The Schedule 3 variant corresponding to the certificate has been checked
• □ The deemed conformity coverage has been annotated in the checklist
• □ Misuse of the pharmaceutical GMP licensing pathway has been ruled out
• □ The CASO 2019 full-text application start date of 31 March 2019 has been recorded

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