Record Keeping and Annual Reports: Which Devices Report, for How Long, and What to Retain

1. Key takeaways

Australia does have a statutory annual reporting obligation, but it covers only three device groups: Class III devices, Class IIb implantable devices and Class 4 IVDs. Under section 41FO(2) of the Therapeutic Goods Act 1989 and clause 5.11 of the Therapeutic Goods (Medical Devices) Regulations 2002, the reports are due by 1 October each year, and the official wording is the first three years after inclusion in the ARTG. Outside those three groups the annual report duty does not arise, but the record-keeping duties described below apply across the device range with differing retention periods, so scoping the obligation correctly is the first task. The three groups are fixed by the provisions; portfolio composition, not preference, decides who reports.

2. Legal basis

Annual reporting sits alongside a set of record-keeping and information duties, each with its own retention period and its own starting point. The provisions below are the ones sponsors most often need to reconcile. Note that the retention periods run from different starting points — the last distribution of product for distribution records, and the last manufacture of a device for conformity assessment evidence — and that confusing the two starting points is a common finding in internal reviews. Sponsors relying on written agreements with manufacturers for the 10–20 working day information commitments should also check that such agreements exist for every manufacturer in the portfolio.

1. Annual reports: Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compiled version F2026C00883), clause 5.11; the umbrella provision is section 41FO(2) of the Therapeutic Goods Act 1989. Official wording: Provide annual reports for the first three years where a Class III, Class IIb implantable, Class 4 IVD device is included in the ARTG.
2. Retention of distribution records: clauses 5.10 and 8.1(b); the retention period is 10 years for Class 4 IVDs, Class III devices and Class IIb implantable devices, and 5 years for other devices (running from the date of distribution of the last batch of product).
3. Storage and transport requirements: clause 5.9 — devices must be stored and transported in accordance with the manufacturer’s instructions and accompanying information.
4. Conformity assessment (CAP) evidence records: retained for at least 5 years after the last device is manufactured, and provided to the TGA on request.
5. Timeframes for obtaining information (not adverse events): written agreements with manufacturers usually require further information to be obtained within 10–20 working days (section 41FN(3)).
6. Additional conditions: section 41FO(2)(c) — the Secretary may attach conditions requiring records to be kept for tracing and locating devices after supply.

3. Expert insights

Insight 1: the “first three years” for annual reports is official guidance wording, not a standalone period in the regulation text. Clause 5.11 establishes the reporting obligation, and the official guidance expresses it as three years. When building the compliance calendar, companies should follow the official wording, plan on a three-year basis, and at the same time keep open the possibility that the obligation continues. Where an entry has been included for less than three years at the time of verification, the calendar should simply carry all three years from inclusion. A calendar entry that simply expires after year three is the wrong design; the correct pattern is a review point at which continuation is assessed rather than assumed away, and the review should be minuted so that the three-year judgement is on record.

Insight 2: the 10-year and 5-year distribution record periods run from the date of the last batch distribution. They do not run from the registration date or the date of manufacture. This means that for a discontinued product the record retention period starts with the final shipment — records that are easily destroyed too early. Discontinuation decisions should therefore trigger a retention review rather than a disposal decision, and the review should be minuted. The same logic applies to in-transit and consignment stock: the last distribution may occur long after the commercial decision to stop supplying. Disposal policies keyed to product status rather than to dates are the ones that fail here.

Insight 3: the 5-year period for CAP evidence is independent of the distribution records. Conformity assessment evidence must be retained for at least 5 years after the last device is manufactured. It forms a separate archive from the distribution records, and a single destruction policy cannot govern both, because the two archives start their clocks on different events. Conformity assessment evidence is also the substrate for any future change or renewal activity, which is a second reason not to fold it into the distribution archive; a change or renewal prepared without it will be incomplete.

4. Practical recommendations

• Build an annual report calendar for the three device groups, fixed to complete before 1 October each year, and retain the submission receipts as proof of timely performance, filed with the dated calendar entry for the same year.
• Manage distribution records in 10-year and 5-year tiers, recording the starting point as the date of the last batch distribution, and linking the archive to the discontinuation decision for the product.
• Maintain a separate 5-year retention policy for the CAP evidence archive, with the starting point recorded as the date the last device was manufactured.
• Write the 10–20 working day information-obtaining commitment into agreements with manufacturers, and retain records of performance so that the agreement can be evidenced as met; agreements that are silent on the timeframe should be updated at the next renewal.

5. Verification checklist

• □ Annual reports for the three high-risk device groups are in the annual calendar (before 1 October)
• □ Distribution records are tiered at 10 years and 5 years, starting from the last distribution date
• □ A separate 5-year retention policy is in place for CAP evidence
• □ The 10–20 working day information commitment is written into agreements
• □ It has been checked whether the entry carries tracing conditions under section 41FO(2)(c)

Regulatory information verified as of 29 October 2026.

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 adverse event reporting and recall coordination with the TGA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com