If you have an FDA-cleared mindset and a device that still needs first-in-human data, two destinations keep showing up in the same conversation: Australia and Latin America. The question I get from US founders is almost always the same. Which one is actually faster, cheaper, and usable for the FDA conversation that comes next?
The honest answer is that they solve different bottlenecks. Treating them as substitutes is how programs lose a year.
What Australia is actually good at
Australia is a mature English-language early-feasibility market. CTN/CTX, experienced ethics committees, and a site culture that knows US sponsors are the reason it became the default OUS FIH destination for a decade. If your protocol is already written for an English-speaking academic site, and your device import is simple, Australia can look like the path of least resistance.
The calendar is not automatic. Ethics plus site contracting plus import still stack. Sponsors who budget “12 weeks to FPI” because they read a slide about CTN often discover that the CTN is not the critical path. Contracting and device logistics are.
What Latin America is actually good at
Latin America is not one market. Colombia (INVIMA), Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), and Panama (MINSA) have different clocks, different ethics stacks, and different import rules. What they share, when the program is set up correctly, is investigator access, procedure volume in cardiovascular and structural heart, and a cost base that is usually 40 to 60 percent below a comparable US or Australian per-patient number.
The bottleneck is rarely science. It is the dossier language, the in-country holder or importer of record, and whether you picked the right trámite before the first document was drafted. A sworn translation that arrives late, or a holder that is also your distributor, will eat more calendar than the ethics review itself.
The comparison that actually matters
- Language and dossier. Australia lets you keep an English core. LATAM does not. INVIMA’s traducción oficial is not a “certified PDF from a US vendor.” Plan the translation tier on day one, from the source language, not through an English hop.
- Ethics vs regulator. In both regions, ethics can move while the regulator is still asking for a missing form. In Colombia, the CEI clock and the INVIMA clock are not the same clock. In Australia, HREC approval does not mean the site is open.
- Import and device custody. A first-in-human implant or catheter does not travel like a pill. Customs, cold chain, and who is the importer of record decide whether FPI slips by weeks after every approval is “done.”
- FDA usability. OUS FIH data can support an IDE conversation when the protocol, monitoring, and endpoint definitions were written for that use on day one. Running a cheaper study that FDA later treats as exploratory is not a savings. It is a redo.
- Cost. Per-patient cost in Colombia or Panama is usually lower than Australia. Total program cost only wins if you do not pay for a second FIH because the first one was not designed to travel.
When I tell a sponsor to pick Australia
Pick Australia when the device is already set up for an English academic workflow, the implanting volume you need exists there, and your next FDA interaction is weeks away rather than a year away. It is also the better default if you have no in-country regulatory infrastructure in LATAM and you are not willing to build it.
When I tell a sponsor to pick Latin America
Pick Latin America when enrollment speed and procedure volume are the constraint — structural heart, neurovascular, and other high-volume hospital procedures — and you are willing to treat INVIMA, ANVISA, or COFEPRIS as a designed pathway instead of a translation of the Australian packet. It is also the better default if you already need a LATAM authorized representative or in-country holder for a later commercial filing. The trial import and the later registro are not the same trámite, but they reward the same discipline.
The mistake that burns both options
Copying a US protocol, swapping the letterhead, and calling it an OUS FIH. Australia will make that look viable longer than it is. Latin America will reject it earlier, usually on a form or a translation, which feels slower and is actually cheaper than discovering the protocol cannot support the IDE after 20 patients.
Write the protocol for the data you need FDA to accept. Then pick the country whose ethics, import, and site activation calendar can deliver that protocol. The region is a tactic. The evidence plan is the strategy.
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