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Device labelling review planned in Australia:

This article was originally published in Clinica

Executive Summary

Australia's Therapeutic Devices Branch (TDB) is to undertake a review of the existing legislation covering labelling of medical devices, says the Australian Therapeutic Device Bulletin. Issues identified for consideration include sterility, pyrogenicity and warning statements relating to scheduled poisons or the observation of precautions. The TDB also believes there is a need to make more product information available to device users and consumers. Depending on the product, this information could include: instructions for use; explanation of possible risks/benefits; general warnings/precautions; set-up and check-out procedures; cleaning procedures; and maintenance, troubleshooting and storage information, the TDB suggests.





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