An ANZ MedTech market-entry primer

Australia and New Zealand are often grouped together as a single 'ANZ' market, but for MedTech they behave as two related-but-distinct regulatory and procurement environments. Treating them as one block is the most common (and most expensive) mistake we see.

The first 90 days should be regulatory-led: confirm the appropriate TGA classification, identify whether a local sponsor is required, and scope the gap between your existing technical file and the Australian conformity assessment route. Medsafe notification in New Zealand can typically run in parallel.

Months 3–6 are commercial scaffolding: incorporation or sponsor agreements, distributor vetting (or a decision to go direct), and your first KOL conversations. By month 9 you should have your reimbursement pathway mapped and your first orders in motion.

The pattern that fails is reversed: chasing distributors before regulatory clarity, then discovering the technical file needs work and watching your launch slip two quarters.