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How to Register a Medical Device in Colombia

How to Register a Medical Device in Colombia

1. Regulatory Overview In Colombia, medical devices are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the National Institute for the Surveillance of Medicines and Foods. INVIMA ensures that medical devices entering the...

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How to Register a Medical Device in Brazil

How to Register a Medical Device in Brazil

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:...

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How to register a Medical Device in Argentina

How to register a Medical Device in Argentina

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...

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Introducing LAMA

Introducing LAMA

Welcome to the Inaugural Edition of the LAMA Newsletter! We’re excited to launch our very first newsletter, where we will keep you informed on the latest developments in regulatory and commercial strategies across Latin America. In this initial edition, we’d like to...

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Brazil and Argentina Enhance Trade Relations

Brazil and Argentina Enhance Trade Relations

Brazil and Argentina Enhance Trade Relations and Pave the Way for Medical Product Regulation in Mercosur. In 2018, within the framework of the Summit of Heads of Member States of Mercosur held, Brazil and Argentina signed a joint declaration on Regulatory Convergence...

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