Distribution Records
Overview
Maintaining distribution records is an automatic condition of ARTG inclusion. Sponsors must keep records sufficient to enable the complete and effective tracing and recall of any medical device supplied in Australia. Distribution records are the backbone of any recall operation — without them, a sponsor cannot identify where affected devices have been sent and cannot execute an effective field safety corrective action or recall. The TGA expects sponsors to be able to provide distribution records on request within a reasonable timeframe.
What Distribution Records Must Cover
Distribution records must enable the sponsor to identify, for any given batch or unit of a device:
- Who received the device — the name and contact details of the healthcare facility, distributor, or other customer to whom each batch or unit was supplied
- When it was supplied — the date of supply for each transaction
- What was supplied — device model, lot/batch number, serial number (where applicable), quantity
- The supply chain — if devices were supplied through distributors, records must capture the downstream destination to the extent necessary to enable an effective recall
For devices supplied directly to patients (e.g., direct-to-consumer IVDs, consumer devices), records must include sufficient customer information to enable patient-level notification where a Class I recall requires it.
Record Retention Periods
Distribution records must be retained for:
- At minimum, the expected lifetime of the device plus the regulatory record-keeping period
- For most devices: 5 years from the date of supply of the last device in a batch
- For implantable devices: 15 years from the date of supply — to enable long-term tracing of implants
These periods align with the minimum technical file retention requirements for manufacturers.
Distributors and the Supply Chain
If a sponsor supplies devices through distributors who on-sell to healthcare facilities, the sponsor must ensure their distribution records capture the first point of supply (to the distributor). However, for an effective Class I recall that needs to reach the healthcare facility level, records must go further.
Best practice is to require distributors to maintain records of their onward supply and to include this requirement in distributor agreements. The sponsor should be able to obtain these records from distributors on request.
UDI and Distribution Records
The progressive introduction of Unique Device Identification (UDI) requirements is improving distribution record quality across the industry. UDI-coded devices allow more precise lot-level tracking through the supply chain. Sponsors should integrate UDI data into their distribution record systems to improve recall efficiency.