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How Long Does It Take to Get ANMAT Approval for Medical Devices in Argentina?

How Long Does It Take to Get ANMAT Approval for Medical Devices in Argentina?

by Analia Katriniuk | Oct 14, 2025 | Blog

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,...
Breaking Into LATAM Markets: A Guide for Startups and SMEs

Breaking Into LATAM Markets: A Guide for Startups and SMEs

by Analia Katriniuk | Sep 30, 2025 | Blog

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...
How to Navigate Regulatory Compliance in Latin America: A Comprehensive Guide

How to Navigate Regulatory Compliance in Latin America: A Comprehensive Guide

by Analia Katriniuk | Sep 23, 2025 | Blog

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,...
Strengthening Pharmacovigilance in Chile: ISP Adopts WHO International Standard

Strengthening Pharmacovigilance in Chile: ISP Adopts WHO International Standard

by Analia Katriniuk | Sep 17, 2025 | Blog

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...
LAMA Achieves ANMAT Authorization to Act as Local Representative for Medical Devices

LAMA Achieves ANMAT Authorization to Act as Local Representative for Medical Devices

by Analia Katriniuk | Aug 14, 2025 | Blog

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...
Deep Dive into Our New Post-Market Surveillance Services

Deep Dive into Our New Post-Market Surveillance Services

by Analia Katriniuk | Aug 12, 2025 | Blog

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,...
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Recent Posts

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  • ANMAT Regulations 2025–2026: Regulatory and Commercial Impact Analysis
  • ANMAT Regulatory Reform 2025–2026: New Paradigm for Medical Devices in Argentina
  • ANMAT Disposition 7516/2025: Clinical Research & Pharmacovigilance Update

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