Country Compliance

Sponsors must prepare for increased costs tied to the submission and maintenance of products on the ARTG which will impact their regulatory budget planning and compliance processes.

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.