Date: February 22nd, 2024 The regulatory landscape for dietary supplements (suplementos alimentares) in Brazil has officially shifted. Under Instrução Normativa […]
[Brazil] New rules for dietary supplements Read More »
The global medical technology and healthcare products industry is facing a period of severe turbulence. Ongoing geopolitical tensions in Eastern Europe and the Middle
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
Market entry checklist: 10 key steps to launch a health product in Latin America Read More »
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
[Chile] MINSAL enhances oversight for Medical Devices and IVDs Read More »
Date: January 17th, 2026 The Mexican government officially updated the General Health Law, specifically Article 376. These changes are designed
[Mexico] Streamlined regulations and enhanced safety for medical imports in Mexico Read More »
In the traditional corporate hierarchy, the regulatory affairs department and the commercial sales team have often been viewed as polar opposites.
Aligning regulatory compliance with commercial performance in Latin America Read More »
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
How to build a market entry strategy for regulated health products in Latin America ? Read More »
Date: March 4, 2026 Mexico has begun operational implementation of its fast-track pathway for medical device registration, allowing eligible products
Understanding health regulatory authorities in Latin America is essential for manufacturers of medical devices, pharmaceuticals, food supplements, cosmetics, sanitizers, and
Date: February 18, 2026 The ANVISA has published Normative Instruction (IN) No. 426/2026, establishing the requirements for transmission and management
[Brazil] ANVISA publishes UDI database rules (IN N°426/2026) Read More »
Date: February 5, 2026 The ANVISA has published RDC No. 1.015/2026, revising and updating the regulatory framework for granting sanitary
[Brazil] ANVISA publishes new cannabis regulation (RDC N° 1.015/2026) Read More »
Date: November 12, 2025 The ANVISA has updated its list of Equivalent Foreign Regulatory Authorities (AREEs) through the publication of
[Brazil] ANVISA updates reliance authority list (IN No. 403/2025) Read More »
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 »
Date: October 29, 2025 The Federal Council of Medicine (CFM) has officially authorized the use of ozone therapy for specific
[Brazil] Ozone therapy authorized for specific medical treatments in Brazil Read More »
ANVISA presented the latest results of its Strengthening and Modernization Plan during a meeting of the Executive Group of the
