Connected Medical Devices and Software (SaMD): What Latin American regulators require in 2026
SaMD stands for Software as a Medical Device. Brazil, Mexico, and Colombia now regulate these products through dedicated frameworks. This […]
Latin America market insights
Becoming an official health product importer in Brazil: the Registration Holder model
A Brazilian Registration Holder is the local entity that legally imports and registers your health product in Brazil. Foreign manufacturers
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How to optimize your classification in Peru before submission
Preparing a medical device registration in Peru requires more than translating a technical file. Correct classification in Peru is the
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Regulatory Gateways in Latin America: A new era of harmonization for medical devices and healthcare products
The global medical technology and healthcare products industry is facing a period of severe turbulence. Ongoing geopolitical tensions in Eastern Europe and the Middle
Market entry checklist: 10 key steps to launch a health product in Latin America
The Latin American healthcare market represents a massive opportunity for international manufacturers. With a population exceeding 650 million people and a rising demand for innovative medical devices, pharmaceuticals, and digital health solutions, the region is highly attractive. However, navigating this territory without a clear roadmap can lead to costly delays. To successfully expand, companies must transform their grand
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Aligning regulatory compliance with commercial performance in Latin America
In the traditional corporate hierarchy, the regulatory affairs department and the commercial sales team have often been viewed as polar opposites.
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How to build a market entry strategy for regulated health products in Latin America ?
Expanding into international markets with regulated health products, including medical devices, pharmaceuticals, food supplements, cosmetics, sanitizers, and veterinary products, requires more than identifying commercial opportunities. Companies
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Health regulatory authorities in Latam: country by country guide
Understanding health regulatory authorities in Latin America is essential for manufacturers of medical devices, pharmaceuticals, food supplements, cosmetics, sanitizers, and
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