Australia Medical Device ARTG Inclusion Process: Timelines and Steps

1. Key takeaways

Australian ARTG entry involves two statutory timelines that are easy to confuse: the TGA’s initial assessment of an inclusion application takes 20 working days from payment of the application fee, while the decision on an application for a conformity assessment certificate takes 255 working days, and the latter applies only where the Secretary must review the design of the device. The 20 working days are not the time to an ARTG number; they are the time to one of three possible outcomes. All facts in this article were verified against official sources as of 29 October 2026. Both figures come straight from the primary instruments, and mixing them up in a project plan is the most common scheduling error we see in Australian programs.

• Initial assessment of an inclusion application: 20 working days from the date the application fee is paid.
• Decision on a conformity assessment certificate under regulation 4.3(1)–(3): 255 working days, applying only where the Secretary must review the device design.
• The initial assessment ends in one of three outcomes: refusal, inclusion, or selection for audit.
• Regulation 5.2 gives the sponsor 20 working days to obtain information from the manufacturer — a duty on the sponsor, not a TGA assessment deadline.
• Once an application is selected for audit, the audit fee must be paid within 28 days of the notice (regulation 9.2).

2. Legal basis

The two timelines and the process steps below trace directly to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, supplemented by the TGA’s published description of the inclusion process. Because each provision sets its own clock, the analysis below quotes the exact section and regulation numbers so the schedule can be defended provision by provision.

• Therapeutic Goods Act 1989 (Act No. 21, 1990, compilation C2004A03952): matters to be declared in the application are set out in section 41FD; accompanying information in section 41FDB; and information required for audit purposes in section 41FH.
• Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the decision period for conformity assessment certificates is set out in regulation 4.3(1)–(3) — 255 working days, applying only in cases where the Secretary must review the design of the device; the clock stops for information requests, reconsideration, and periods agreed between the parties. The sponsor’s period for obtaining information from the manufacturer is set out in regulation 5.2 — 20 working days (prescribed for the purposes of sections 41FD(e)(ii) and 41FD(g)(ii) of the Act). Mandatory application audit is covered by regulation 5.3.
• Official process: confirm that the product needs inclusion in the ARTG → determine the “kind of medical device” → classify the device → obtain manufacturer evidence accepted by the TGA → obtain a Client ID and lodge the application with the fee through TGA Business Services (TBS) → initial assessment → one of three outcomes (refusal, inclusion, or selection for audit) → print the ARTG inclusion certificate.
• Initial assessment timeframe: completed within 20 working days from the date the application fee is paid, as stated on the TGA page “Processing your application for inclusion of a medical device”.

3. Expert insights

Insight 1: the three outcomes run in parallel, not in series. The output of the initial assessment is one of “refusal”, “inclusion”, or “selected for audit”. Only the “inclusion” outcome produces an ARTG number; if the application is “selected for audit”, the time is counted separately. Scheduling a project against the 20 working days alone effectively excludes the audit period from the plan, which is the single most common cause of missed launch dates in Australian programs. Planning teams should therefore carry a separate audit-scenario line in the schedule from day one, rather than treating the audit as an exception handled after the fact.

Insight 2: the 255 working days cover only the certificate route that reviews design. The applicability condition in regulation 4.3(1) is drafted narrowly — it applies only where the Secretary must review the design of the device. Certificate applications that do not require a design review fall outside that statutory ceiling, which explains why actual timelines for nominally identical certificates vary widely in practice. In our projects we ask the case officer early whether design review will be required, because the answer decides which of the two clocks the certificate project actually runs on.

Insight 3: the 20 working days in regulation 5.2 bind the sponsor. That provision governs the period within which the sponsor must obtain information from the manufacturer, and it is frequently misread as a TGA assessment deadline. When we build project schedules we list these two “20 working day” periods as separate lines, so that the regulatory team and the technical team never end up waiting on each other for the wrong clock. Because the manufacturer controls when it delivers that information, the obligation is best managed contractually rather than chased ad hoc during the assessment window.

4. Practical recommendations

• Split the schedule model into three segments: the evidence segment (manufacturer evidence, with no official time limit), the initial assessment segment (20 working days), and a possible audit segment (counted separately). Reserve buffer in the audit segment according to the classification and the scope of the mandatory audit.
• Complete the locking of the “kind” and the classification decision before submission, so the application is not returned for correction and the clock reset.
• Sign a written agreement with the manufacturer that writes the regulation 5.2 20 working day information-obtaining obligation into its clauses, together with agreed remedies for breach.
• Once the application is selected for audit, start preparing the audit materials immediately and check the audit fee payment deadline in parallel (regulation 9.2 requires payment within 28 days of the notice), so the payment never becomes the critical path.

5. Verification checklist

• □ The “initial assessment 20 working days” and the “certificate decision 255 working days” have been distinguished
• □ Kind determination and classification decision have been completed
• □ Manufacturer evidence has been accepted by the TGA and receipts retained
• □ A Client ID has been obtained and the TBS account configured
• □ The agreement with the manufacturer includes the 20 working day information-obtaining obligation
• □ A 28 day payment window for the audit fee has been reserved

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