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Introduction Brazil is one of Latin America’s largest and most complex medical device markets, governed by the National Health Surveillance Agency (ANVISA). Manufacturers aiming to enter this market must navigate a stringent regulatory framework to obtain and maintain market authorization. Despite clear guidance from ANVISA, companies frequently make avoidable mistakes that delay product approval or […]

Introduction As Brazil continues to solidify its position as a significant player in the global medical device market, understanding its regulatory landscape becomes paramount for manufacturers aiming to enter or expand within this dynamic environment. A fundamental aspect of this landscape is the classification of medical devices, governed by the Brazilian Health Regulatory Agency (ANVISA).

Introduction Brazil’s medical device market presents significant opportunities for manufacturers worldwide. However, navigating the regulatory landscape governed by ANVISA (Agência Nacional de Vigilância Sanitária) requires a thorough understanding of the processes involved. This guide provides a comprehensive overview of the ANVISA medical device registration process, tailored for manufacturers seeking market entry into Brazil. 1. Understanding

Introduction The global medical device industry is undergoing significant transformation, with emerging markets like Brazil offering substantial growth opportunities. For Indian manufacturers, Brazil presents a strategic avenue to expand their global footprint, given its sizeable healthcare market, increasing demand for medical technologies, and a regulatory environment that is progressively aligning with international standards. 1. Brazil’s

Introduction Navigating the European Union’s Medical Device Regulation (EU MDR 2017/745) is a complex endeavor for manufacturers aiming to achieve CE marking. The EU MDR introduces stringent requirements, emphasizing patient safety and device efficacy. As regulatory consultants, we’ve observed recurring mistakes that can impede the certification process. This article outlines these common pitfalls and offers

Introduction The European Union Medical Device Regulation (EU MDR) 2017/745 has significantly transformed the regulatory landscape for medical devices. One of its pivotal components is the requirement for a comprehensive Clinical Evaluation (CE), which ensures that medical devices meet stringent safety and performance standards before entering the EU market.  Understanding Clinical Evaluation Under MDR Clinical