TGA vs Medsafe: what actually differs

The TGA operates a risk-based conformity assessment regime aligned in part with EU MDR. Medsafe runs a notification system under the WAND database. They are not interchangeable, and a TGA inclusion does not automatically grant New Zealand market access.

For Class IIa and above, expect TGA timelines of 6–12 months depending on whether you can leverage an EU MDR or comparable overseas certificate. Medsafe notification is faster but does not substitute for the underlying conformity evidence.

Post-market obligations differ meaningfully: incident reporting thresholds, recall protocols and labelling requirements all need local procedures. Most overseas sponsors underbudget the post-market workload by a factor of two.