TGA Updates Guidance on Selection Criteria for Medical Device Application Audits
The TGA has updated its guidance on how medical device applications are selected for audit before inclusion in the ARTG, including mandatory audits, non-mandatory audit criteria, regulatory reforms, UDI and post-market signals.
TGA Updates Guidance on the Use of Comparable Overseas Regulatory Assessments for Medical Devices
The Australian TGA updated its guidance on the use of overseas regulatory assessments for medical devices, including recognition of UK MHRA approved bodies. Learn what this means for manufacturers seeking ARTG inclusion.