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
Mexico fast-track medical device registration now operational: 30-day COFEPRIS pathway Read More »
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
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
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
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
ANVISA regulates nasal saline solutions as Medical Devices Read More »
ANVISA presented the latest results of its Strengthening and Modernization Plan during a meeting of the Executive Group of the
