Australia Medical Device Conformity Assessment Procedures: Schedule 3 and the CAP Reform

1. Key takeaways

The old shorthand of “eight CAPs” is out of date. Under the current Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 contains 10 Parts, of which Part 8 (clinical evaluation procedures) applies mandatorily to the device categories designated by regulation 3.11. The TGA has run a public consultation on amendments to the CAPs, open from 18 December 2025 to 14 April 2026, covering 8 proposals in total. The consultation documents are the best available signal of where the TGA intends to take the CAP framework over the coming cycle. Facts in this article were verified as of 29 October 2026.

• Schedule 3 now has 10 Parts, not eight; the authorised provision is regulation 3.4.
• Part 8 is expressly “must be applied”, with the applicable device categories designated by regulation 3.11.
• Proposals 1–5 mainly target the CAPs underpinning TGA conformity assessment certification (or future Australian Approved Body certification).
• Proposals 6, 7 and 8 also apply to devices certified by trusted overseas regulators — the points most relevant to companies relying on overseas evidence.
• The consultation expressly does not change the way approvals and assessments by overseas regulators are recognised.

2. Legal basis

The conformity assessment procedures (CAPs) are a creature of Schedule 3 to the Regulations, and their structure determines which evidence route a manufacturer can use for any given device. The mandatory status of Part 8 also changes how the whole Schedule should be read, not merely which Part is selected.

• Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the CAPs are set out in Schedule 3; the empowering provision is regulation 3.4; the current version contains 10 Parts.
• The ten Parts and their statutory names (Dictionary): Part 1 full quality assurance procedures; Part 2 type examination procedures; Part 3 verification procedures; Part 4 production quality assurance procedures; Part 5 product quality assurance procedures; Part 6 declaration of conformity procedures (no assessment by the Secretary required); Part 6A in-house IVD procedures for Class 1–3; Part 6B in-house IVD procedures for Class 4; Part 7 procedures for medical devices used for a special purpose; Part 8 clinical evaluation procedures.
• Mandatory application: the note to regulation 8.1 of Schedule 3 Part 8, together with regulation 3.11 — Part 8 is “must be applied”, with the device categories designated by regulation 3.11.
• Amendment in progress: TGA “Public consultation for proposed changes to medical device conformity assessment procedures”, consultation period 18 December 2025 to 14 April 2026 (originally set to close on 27 February 2026 and extended following industry feedback); proposals 1–5 mainly concern the CAPs on which TGA conformity assessment certification (or future Australian Approved Body certification) is based, while proposals 6, 7 and 8 also apply to devices certified by trusted overseas regulators; the consultation expressly does not change the way approvals and assessments by overseas regulators are recognised.

3. Expert insights

Insight 1: Part 8 writes clinical evaluation into the legal source of conformity assessment. This differs from the European approach, where clinical evaluation sits within the technical documentation and the notified body review. Australia lists “clinical evaluation procedures” as one of the CAPs and makes them mandatorily applicable, which means clinical evidence is not “supporting material” but a statutory component of conformity assessment. Treating it as an annex, as some teams do when transplanting EU dossiers, invites adverse findings. Dossiers imported unchanged from EU technical files routinely need a dedicated clinical evaluation section structured against the CAP, not merely cross-references to the file.

Insight 2: proposals 6, 7 and 8 are the real concern for most Chinese companies. Proposals 1–5 mainly affect products that go through the TGA certificate route; products that rely on evidence from overseas regulators are equally affected by proposals 6, 7 and 8. Reading only the first five proposals understates the scope of change, because the majority of imported devices enter Australia on overseas evidence rather than on TGA-issued certificates. For sponsors preparing overseas-evidence submissions, the three proposals deserve their own line on the regulatory watchlist, with an owner and a review date attached.

Insight 3: Part 6 is the channel with no Secretary assessment. The declaration of conformity procedures do not require assessment by the Secretary, which makes them the shortest path for Class I devices that are non-sterile and non-measuring. But this is not the same as “no obligations” — responsibility for compliance with the essential principles remains in place (see article 06 in this series for the related discussion of EU certificates). The trade-off is that the declaration route places the burden of demonstrating essential principles compliance squarely on the manufacturer and sponsor, with no assessment step to catch gaps.

4. Practical recommendations

• Build a CAP selection matrix across three dimensions — classification, whether the device is sterile or measuring, and whether overseas evidence exists — confirm the applicable Part, and state the supporting provision in the technical documentation.
• For products where Part 8 applies mandatorily, archive the clinical evaluation evidence chain separately, so it does not get mixed with quality management system evidence.
• Track the follow-up legislative instruments from the CAP amendment consultation and complete an internal comparison within 30 days of the official text being published, and brief the project teams on any change that touches an active submission.
• For projects on the TGA certificate route, pay extra attention to the direction of strengthening on quality management and design control in proposals 1–5, and close gaps in design control evidence for software and emerging technologies early.

5. Verification checklist

• □ The applicable pathway has been reviewed against the current 10 Parts of Schedule 3, not the old eight
• □ The Part number and provision relied on for the applicable CAP are stated in the technical documentation
• □ Whether the product falls within the Part 8 mandatory scope designated by regulation 3.11 has been confirmed
• □ The impact of proposals 6, 7 and 8 on this product has been assessed
• □ A tracking mechanism for CAP amendment legislative instruments, with a 30 day comparison step, is in place

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 manages TGA ARTG inclusion across all classes, prepares conformity assessment dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanlang.com