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 Medical Device Application Audit Selection Criteria
The TGA has updated its guidance on how medical device and IVD applications are selected for audit before inclusion in the ARTG.