How should a MedTech or biotech company approach Latin America market entry?

Sequence it: anchor on US regulatory strategy first, use Latin America for fast, lower-cost first-in-human and early-feasibility data, then stage market access (device registration plus reimbursement) country by country. bioaccess® runs the clinical and regulatory execution end to end.

From the Global Trial Accelerators™ podcast with Carolina Alarco (Bio Strategy Advisors): watch the episode.

How to sequence Latin America market entry

Anchor on US regulatory strategy first (FDA Pre-Sub, IND/IDE) so data is portable
Generate first-in-human / early-feasibility data in LATAM — materially faster, lower per-patient cost
Stage market access country by country: device registration (INVIMA, COFEPRIS, ANVISA, etc.)
Layer in reimbursement / HTA where commercialization is the goal
Use an importer-of-record and in-country regulatory support to de-risk logistics

Frequently asked questions

Should I get FDA clearance before entering Latin America?

Not necessarily — many companies use Latin America to generate first-in-human data that feeds a US submission. The key is to anchor on US regulatory strategy from the start (e.g. an FDA Pre-Sub) so the LATAM data is acceptable, then pursue local registration and market access as commercialization goals emerge.

Which Latin American country should I enter first?

It depends on your indication, target population, regulatory timeline, and cost tolerance. Colombia offers fast INVIMA approval; Brazil offers scale; Mexico offers US-adjacent logistics. bioaccess® helps sequence country entry against your clinical and commercial goals.

What's the difference between registration and reimbursement in LATAM?

Registration is regulatory authorization to sell a device (e.g. INVIMA, COFEPRIS, ANVISA). Reimbursement / market access is about getting payers to cover it. Clinical-stage companies usually start with first-in-human data and registration; reimbursement matters once you commercialize.