Our response to questions asked about the Essential Principles consultation
Medical devices Essential Principles: Part 2 - Proposed changes to align with the European Regulations
Published
Related content
-
Recall reforms program update
The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety. -
TGA AI Review: Outcomes report published
We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report. -
Product Information inserts are no longer required for injectable medicines administered by health professionals
Find out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023.