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Regulatory and Commercial Impact Analysis of ANMAT Regulations 2025–2026 1. GENERAL CONTEXT OF REGULATORY CHANGES Strategic Orientation The regulations issued by ANMAT between October 2025 and February 2026 respond to a clear strategy of modernization and...

Introduction: A Wind of Change in Health Regulation In recent months, Argentina's National Administration of Drugs, Foods, and Medical Technology (ANMAT) has driven a series of regulatory reforms that redefine the landscape for the import, manufacture, and...

Healthcare in Latin America is evolving rapidly in 2025. From digital transformation and regulatory modernization to supply chain optimization and patient-centered care, the region is embracing innovations that improve access, quality, and efficiency. While artificial...

When entering the Argentine market, one of the most common questions we receive from manufacturers is: “How long will it take to get ANMAT approval for my medical device?” It’s an important question. Timelines are key when planning a launch, coordinating distribution,...

Expanding your business into Latin America (LATAM) can be a transformative step for startups and SMEs. The region, with its growing middle class, vibrant entrepreneurial ecosystem, and diverse market opportunities, promises significant potential; but it also presents...

Expanding into Latin America offers tremendous opportunities for businesses, particularly in sectors such as medical devices, pharmaceuticals, cosmetics, and consumer goods. However, navigating regulatory compliance in the region can be complex due to varying laws,...

On September 15, 2025, the Instituto de Salud Pública de Chile (ISP) announced the implementation of the World Health Organization’s (WHO) international pharmacovigilance standard to enhance the safety monitoring of medicines and vaccines in Chile. 🔍 What Is the WHO...

After moving into our new headquarters in Buenos Aires last year, LAMA took a major step forward by applying to ANMAT for authorization to act as local representatives and importers for medical devices. We are delighted to officially announce that this permission has...

Recently, LAMA announced the launch of our expanded post-market surveillance offering, including services in pharmacovigilance, technovigilance, and cosmetovigilance. These disciplines work to ensure that medicines, medical devices, and cosmetics remain safe,...