“Maintaining comprehensive distribution records isn’t just a regulatory requirement—it’s a commitment to consumer safety and product traceability. The TGA ensures swift recalls and the highest standards of regulatory compliance.”

Jack Liang

Managing Partner, Asia Actual Australia

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TGA Emphasizes Medical Device Distribution Record-Keeping

Published on: July 10th, 2024

On May 23rd, 2024, the Therapeutic Goods Administration (TGA) updated its distribution records page for medical devices. The TGA requires sponsors and manufacturers of therapeutic goods to maintain comprehensive distribution records. These records are essential for ensuring the traceability and safety of therapeutic goods in the Australian market.
The TGA specifies that providing distribution information is essential to expediting recalls on medical devices and being able to identify the manufacturer of each batch. By adhering to guidelines, sponsors and manufacturers contribute to maintaining high standards of regulatory compliance and consumer safety in Australia. For more detailed information, you can visit the TGA’s official distribution records guidelines here.

Medical Device Distribution Record Retention

The TGA keeps records for 5 to 10 years, depending on device classification:

Device ClassificationRetention TIme
Class 4 IVD10 years
Class III10 years
Class IIb10 years
All other classifications5 years

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