Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
Adverse event reporting

Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 reporting-deadlines: Report within 10 or 45 days, electronically

What does reporting-deadlines require?

The report must include the healthcare identifier, the relevant dates and the nature of the deterioration, and the manufacturer's name if known. A death or serious deterioration is reported within 10 days of the death or first identification. An intervention or treatment case is reported within 45 days. The report must be given in an electronic form, not by fax or a scanned document.

Maintained by Gerard Blokdyk

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