Titans Medical

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

Introduction The integration of Artificial Intelligence (AI) into medical devices has revolutionized healthcare, offering enhanced diagnostics, personalized treatments, and improved patient outcomes. However, with innovation comes the responsibility to ensure safety, transparency, and ethical use. Recognizing this, the European Union introduced the Artificial Intelligence Act (AI Act), formally known as Regulation (EU) 2024/1689, establishing a

Introduction When it comes to entering the European Union (EU) market, CE marking is a crucial certification that signifies a medical device’s compliance with EU regulations. For medical device manufacturers, the EU Medical Device Regulation (MDR 2017/745) sets out strict guidelines to ensure safety and performance before marketing a device in Europe. As a medical