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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 batches of the medical devices; and
- identify the manufacturer of each batch of devices.
Sponsors are not required to maintain records of the individual users of medical devices, but should maintain records of distribution centres, hospitals and export countries the device has been supplied to.
Sponsors must retain their records for ten or five years after the last product has been distributed, depending on the classification of the devices.
|Classification of device||Record retention period|
|Class III||10 years|
|Class IIb implantable||10 years|
|All other classifications||5 years|
These records, or copies of the records, must be provided when requested by the TGA.
The Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use, available on the TGA website, sets out appropriate procedures for wholesalers and/or distributors to ensure that there is effective, efficient and safe handling, storage and distribution of products. It is in the sponsor's interest to encourage their wholesalers to follow this Code.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Medical Devices Branch||October 2019|