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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 Classification	Retention TIme
Class 4 IVD	10 years
Class III	10 years
Class IIb	10 years
All other classifications	5 years

Come Grow With Us

Please contact us if you are interested in registering your product in Australia. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services in Australia and the rest of Asia.