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 device | Record retention period |
|---|---|
| Class 4 IVD | 10 years |
| Class III | 10 years |
| Class IIb implantable | 10 years |
| All other classifications | 5 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.