The Australian Therapeutic Goods Administration (TGA) has updated its medical device distribution record requirements from 23 May 2024.
Under section 41FO of the Treatment Supplies Act 1989, sponsors of medical devices supplied and exported from Australia must keep the following distribution record.
- Expedite any recalls of the medical devices.
- 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.
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 |
Please refer to the link below for more information.
Distribution records | Therapeutic Goods Administration (TGA)
Distribution records
Information on the requirement for sponsors to keep distribution records
www.tga.gov.au
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