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Distribution records

Information on the requirement for sponsors to keep distribution records.

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Under section 41FO of the Therapeutic Goods Act 1989 sponsors of medical devices supplied in, and exported from, Australia are required to keep distribution records to:

  • expedite any recalls of the medical devices; and
  • identify the manufacturer of each batch of devices.

Records should be kept of where the device has been supplied, including users, distribution centres, hospitals, and export countries.

Retaining records

Records have to be kept for a minimum of 10 or 5 years, depending on the classification of the device.

Classification of deviceRecord retention period
Class 4 IVD10 years
Class III10 years
Class IIb implantable10 years
All other classifications5 years

If we ask for these records, or copies, you must provide them.

Wholesalers and distributors have procedures to make sure products are handled, stored, and distributed safely. See the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use.

It is in the sponsor's interest to encourage their wholesalers to follow this Code.

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