LATAM
Expanding Regulatory Horizons Across Latin America
Our Objective
Our objective in Latin America is to support medical device and digital health companies in achieving compliant, efficient, and sustainable market access across a region characterized by diverse regulatory frameworks and evolving national requirements. We assist our partners in navigating country-specific registration pathways, local representation obligations, and post-market responsibilities, while anticipating regulatory changes. Through expert guidance and end-to-end regulatory support, we ensure that innovative technologies reach patients safely and in full alignment with local health authorities across Latin America.
Our objective
We guide our partners through the complexity of Latin American regulatory submissions. Our regional experts and local partners ensure efficient market entry, proactive communication with authorities, and full compliance with local standards. We cover all key economic regions — MERCOSUR, Pacific Alliance, SICA, and CARICOM — offering tailored strategies for each market.
MERCOSUR & Pacific Alliance
Argentina is a gateway to a growing and regulated healthcare ecosystem in the Southern Cone
Brazil stands as a central gateway to one of the largest and most regulated healthcare ecosystems in Latin America
Mexico offers a dynamic and highly regulated healthcare market, serving as a strategic entry point to North and Central America
Paraguay provides a stable and emerging healthcare market, offering streamlined pathways for medical device entry across South America
Uruguay offers a reliable and transparent healthcare environment, enabling efficient market access for medical devices across the Southern Cone
Bolivia presents a developing yet structured healthcare market, where medical device entry requires clear regulatory alignment and coordinated local support
Chile stands out with a mature and transparent healthcare system, enabling predictable regulatory pathways for medical devices across the region
Colombia combines a structured regulatory framework with a rapidly expanding healthcare market, offering clear pathways for medical device compliance and regional growth
Ecuador maintains a defined regulatory environment supported by growing healthcare modernization efforts, providing clear opportunities for compliant market entry and sustainable expansion
Peru offers a structured regulatory landscape and an evolving healthcare ecosystem, enabling streamlined medical device registration and promising conditions for market growth
"Simon MedTech Solutions guided us seamlessly through regulatory submissions in Brazil, Mexico, and Chile. Their mastery of LATAM requirements and proactive coordination with local authorities made our market entry faster and smoother than expected. A truly reliable partner for the region"
Senior Director - Legal Manufacturer (France)
Regulatory Submissions & Local Representation
End-to-end registrations and reliable local support across LATAM
ANVISA & COFEPRIS Dossier Preparation
Optimized technical files for Brazil and Mexico
Labeling, Import & Compliance Support
Fast support to meet local labeling and import rules
Regulatory Intelligence & Post-Market Maintenance
Ongoing monitoring and renewal of your registrations
Reach
Ready to access Latin America’s most strategic markets? Contact us today and let’s accelerate your regional expansion together
Let’s bring your innovations to Latin America with confidence and regulatory clarity
