Latin America & The Caribbean
Our expertise in Latin American & The Caribbean market access will accelerate your time to market.
Ensure long-term compliance
As a MedTech manufacturer, you know that Latin American and Caribbean markets require dealing with varying regulatory frameworks, each with distinct classification rules, language requirements, import processes, distributor requirements, and mandatory local representation. Companies risk translation issues, delayed registrations, compliance missteps, and increased costs without local insight.
We combine deep in-country regulatory intelligence with on-the-ground representation—from dossier creation and classification to renewal and vigilance oversight—providing a single partner who understands each country’s nuances and can seamlessly coordinate multi-country entry.
Manufacturers represented across 40 markets
Discover how we can help:
South America
We help you with market approval and legal representation in:
- • Brazil
- • Colombia
- • Argentina
- • Peru
- • Venezuela
- • Chile
- • Ecuador
- • Bolivia
- • Paraguay
- • Uruguay
- • Suriname
Central America
We help you with market approval and legal representation in:
- • Mexico
- • Guatemala
- • Honduras
- • Nicaragua
- • Costa Rica
- • Panama
Carribean
We help you with market approval and legal representation in:
- • Haiti
- • Dominican Republic
- • Puerto Rico
- • Jamaica
- • Trinidad and Tobago
- • Bahamas
- • Martinique
- • Barbados
- • Curaçao
- • Grenada
- • Aruba
Without strategic alignment and local expertise, companies often endure translation delays, missed renewal deadlines, misfiled submissions, and regulatory queries reverberating across markets, resulting in blocked device imports, fines, or market withdrawal.
We bring together in-depth local regulatory expertise and on-the-ground support—covering everything from dossier preparation and classification to renewals and vigilance—offering a single, coordinated partner who understands each country's unique requirements and ensures smooth, multi-country market access.
Do you want to outsource market approval to a reliable partner in Latin America and the Caribbean?
Couldn't find your question?
Do I need a different local representative per country?
Yes, Mexico requires a Registration Holder; Brazil also needs one; Argentina and Chile have local agent mandates; and Colombia mandates a Legal Representative and certified importer.
What is the fastest route to register low-class devices?
Mexico offers equivalency pathways, while Colombia permits immediate registration for Class I and IIa devices, allowing early market entry ahead of full review.
How long do registrations last, and are renewals required?
In Colombia, device registrations are valid for 5 or 10 years, depending on class; Brazil, Mexico, Argentina, and Chile have similar multi-year cycles. Renewals must be managed proactively to avoid lapses.
Can my importer be my Legal Representative?
Yes, but that usually gives the importer control over registrations; appointing an independent Legal Representative helps you retain ownership and flexibility.