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 […]
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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[Mexico] 5 rules of the new ANVISA equivalence pathway
COFEPRIS opens an ANVISA equivalence pathway for medicines in Mexico. Scope, filing requirements and the 45-business-day review, explained.
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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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[Brazil] New rules for dietary supplements
Date: February 22nd, 2024 The regulatory landscape for dietary supplements (suplementos alimentares) in Brazil has officially shifted. Under Instrução Normativa
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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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[Chile] MINSAL enhances oversight for Medical Devices and IVDs
Date: March 19th, 2026 The Chilean Ministry of Health (MINSAL) has recently published Exempt Decree No. 25, setting up a new health control regime for a wide range of medical devices (MD) and in vitro
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[Mexico] Streamlined regulations and enhanced safety for medical imports in Mexico
Date: January 17th, 2026 The Mexican government officially updated the General Health Law, specifically Article 376. These changes are designed
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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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[Mexico] Mexico fast-track medical device registration now operational: 30-day COFEPRIS pathway
Date: March 4, 2026 Mexico has begun operational implementation of its fast-track pathway for medical device registration, allowing eligible products
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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[Brazil] ANVISA publishes UDI database rules (IN N°426/2026)
Date: February 18, 2026 The ANVISA has published Normative Instruction (IN) No. 426/2026, establishing the requirements for transmission and management
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[Brazil] ANVISA publishes new cannabis regulation (RDC N° 1.015/2026)
Date: February 5, 2026 The ANVISA has published RDC No. 1.015/2026, revising and updating the regulatory framework for granting sanitary
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[Brazil] ANVISA updates reliance authority list (IN No. 403/2025)
Date: November 12, 2025 The ANVISA has updated its list of Equivalent Foreign Regulatory Authorities (AREEs) through the publication of
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[Brazil] ANVISA regulates nasal saline solutions as Medical Devices
Date: November 3, 2025 The ANVISA has approved a new regulation classifying sodium chloride-based products intended for nasal irrigation as medical
[Brazil] ANVISA regulates nasal saline solutions as Medical Devices Read More »
[Brazil] Ozone therapy authorized for specific medical treatments in Brazil
Date: October 29, 2025 The Federal Council of Medicine (CFM) has officially authorized the use of ozone therapy for specific
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