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Introduction If you’re planning to introduce your medical device to the Thai market, you’re tapping into one of Southeast Asia’s most promising healthcare economies. With Thailand’s growing demand for advanced medical technologies, especially in diagnostics, surgical equipment, and digital health, the opportunities are significant. However, successfully accessing this market begins with a critical step: Thai […]

Introduction:  Gaining ANVISA certification is a significant milestone for any medical device manufacturer aiming to access the Brazilian market. However, the journey doesn’t end with product registration. Maintaining ANVISA certification requires continuous compliance with post-market requirements set forth by Brazilian regulatory authorities. These obligations not only help safeguard patient safety but also ensure that your

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