by maixaule | Feb 28, 2026 | Blog
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...
by maixaule | Feb 26, 2026 | Blog
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...
by maixaule | Dec 29, 2025 | Blog
ANMAT Disposition 7516/2025: A Regulatory Milestone Transforming Clinical Research and Pharmacovigilance in Argentina December 1st marked a turning point in the Argentine pharmaceutical regulatory landscape. With the entry into force of ANMAT Disposition 7516/2025,...
by maixaule | Nov 7, 2024 | Blog
Registering a medical device in Brazil involves a series of specific steps mandated by the Brazilian Health Regulatory Agency (ANVISA). This guide outlines the process, timelines, and key considerations for developing regulatory strategy in Brazil Step 1:...
by maixaule | Oct 26, 2024 | Blog
In order to market a medical device in Argentina, you must first register this device with the local health authority, ANMAT. In order to complete this registration several steps must be followed. Step 1: Determine whether your device will be eligible to bypass GMP...
