How to build a market entry strategy for regulated health products

How to build a market entry strategy for regulated health products in Latin America ?

Latin America market insights /

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 must plan how their products will meet regulatory requirements, obtain authorization, and be introduced into the local market environment.  Healthcare products are governed by strict regulatory frameworks that differ from one country to another. Manufacturers […]

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Mexico fast-track medical device registration now operational: 30-day COFEPRIS pathway

Mexico - COFEPRIS, Regulatory updates /

Date: March 4, 2026 Mexico has begun operational implementation of its fast-track pathway for medical device registration, allowing eligible products to obtain approval in as little as 30 business days. Although the regulatory framework was introduced in 2025, the pathway is only now becoming fully operational, creating new opportunities for manufacturers seeking faster entry into

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Health regulatory authorities in Latam : pratical guide

Health regulatory authorities in Latin America: A country-by-country guide for market access

Latin America market insights /

Understanding health regulatory authorities in Latin America is essential for manufacturers of medical devices, pharmaceuticals, food supplements, cosmetics, sanitizers, and veterinary products, planning market access in Latam. The region offers strong commercial potential but operates under distinct national regulatory frameworks requiring careful navigation.  In this article, we focus specifically on the countries where Mandala International already operates in Latin America:

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ANVISA publishes UDI database rules (IN N°426/2026)

Brazil - ANVISA / MAPA, Regulatory updates /

Date: February 18, 2026 The ANVISA has published Normative Instruction (IN) No. 426/2026, establishing the requirements for transmission and management of data within Brazil’s Unique Device Identification (UDI) database. The regulation strengthens traceability and transparency for medical devices marketed in Brazil and reinforces post-market control mechanisms. Entry into force: March 1, 2026Non-compliance will constitute a

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ANVISA publishes new cannabis regulation (RDC N° 1.015/2026)

Brazil - ANVISA / MAPA, Regulatory updates /

Date: February 5, 2026 The ANVISA has published RDC No. 1.015/2026, revising and updating the regulatory framework for granting sanitary authorization for cannabis-based products in Brazil. This new resolution replaces the previous regulation and introduces several changes with significant commercial and compliance implications. The updated framework will enter into force on May 4, 2026. Key

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ANVISA updates reliance authority list (IN No. 403/2025)

Brazil - ANVISA / MAPA, Regulatory updates /

Date: November 12, 2025 The ANVISA has updated its list of Equivalent Foreign Regulatory Authorities (AREEs) through the publication of Normative Instruction (IN) No. 403/2025. This list is used within ANVISA’s Reliance framework, allowing the Brazilian authority to leverage prior assessments conducted by recognized foreign regulators for specific regulatory procedures. What is the reliance process

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ANVISA regulates nasal saline solutions as Medical Devices

Brazil - ANVISA / MAPA, Regulatory updates /

Date: November 3, 2025 The ANVISA has approved a new regulation classifying sodium chloride-based products intended for nasal irrigation as medical devices. The decision was approved by ANVISA’s Collegiate Board (Dicol) on October 29, 2025 and formalized through a new Collegiate Board Resolution (RDC), granting the measure full regulatory and normative effect. What does the new

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Ozone therapy authorized for specific medical treatments in Brazil

Brazil - ANVISA / MAPA, Regulatory updates /

Date: October 29, 2025 The Federal Council of Medicine (CFM) has officially authorized the use of ozone therapy for specific medical indications through Resolution CFM No. 2,445/2025. This new resolution revokes Resolution CFM No. 2,181/2018, which had previously classified ozone therapy as an experimental procedure in Brazil. This update represents an important milestone for manufacturers

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ANVISA announces progress in its modernization plan and reinforces commitment to reducing backlogs

Brazil - ANVISA / MAPA, Regulatory updates /

ANVISA presented the latest results of its Strengthening and Modernization Plan during a meeting of the Executive Group of the Health Economic-Industrial Complex (GECEIS), held in São Paulo on November 24, 2025. The initiative aims to reduce regulatory backlogs and improve review timelines across several product categories. Key progress highlights include Medical Devices : A

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