6 JULY 2025As the medical device industry advances across diagnostics, wearables, implants and digital health, Latin America is emerging as a region of growing strategic importance. This rise is fueled by expanding healthcare infrastructure, increasing demand for advanced medical technologies and ongoing regulatory modernization that enables faster and more efficient market entry. A new generation of regulatory consultants is facilitating this growth and providing critical guidance to navigate diverse approval pathways, local representation requirements and evolving compliance standards across the region.Reflecting this trend, Latin America's medical device regulatory affairs market is projected to reach approximately $446.2 million by 2030, growing at a CAGR of 9.4 percent from 2025 to 2030.A slew of technological trends is driving the industry forward. Regulatory intelligence platforms automate the monitoring of regional policy updates, helping consultants stay ahead of changes and ensure clients remain compliant in real time. Cloud-based document management systems streamline the submission and tracking of regulatory dossiers, reducing delays and improving stakeholder transparency. AI-driven data analytics enhance risk assessments and market entry strategies by providing predictive insights based on historical approvals and regional trends.This edition of Healthcare Business Review Latin America spotlights the region's leading medical device regulatory consultants who are setting a new standard for what it means to be regulatory-ready in Latin America. It features insights from Dr. Amos Chery, director of pharmacy operations and regulatory compliance at MedStar Health, who discusses how pharmacy operations must balance innovation with compliance. He emphasizes the role of training, technology and proactive strategies to navigate automation, outsourcing and evolving regulations in healthcare. Roberto Caldeira Cury, executive medical director at Dasa, discusses how the organization is transforming healthcare in Latin America by embracing precision medicine and data-driven diagnostics.The magazine also features Sobel Consultancy, a strategic regulatory partner known for turning complex compliance demands into clear, actionable strategies. Through scalable infrastructure and expert guidance, it helps medical device companies align fast-paced innovation with evolving global regulations.We hope this edition helps your organization build the partnerships it needs to sharpen its competitive edge in the medical regulatory space.Let us know your thoughts!Alex D'souzaManaging Editoreditor@healthcarebusinessreview.comThe Future of Medical Device RegulationEDITORIALManaging EditorAlex D'souzaEditorial StaffAaron PaulGina ClumskyJoe PhillipJames SmithMark RobertYenny TurnerCopyright © 2025 ValleyMedia, Inc. All rights reserved. Reproduction in whole or part of any text, photography or illustrations without written permission from the publisher is prohibited. The publisher assumes no responsibility for unsolicited manuscripts, photographs or illustrations. Views and opinions expressed in this publication are not necessarily those of the magazine and accordingly, no liability is assumed by the publisher thereof.Email:sales@healthcarebusinessreview.comeditor@healthcarebusinessreview.commarketing@healthcarebusinessreview.comVisualizersVictor CruzCelestial JordanJULY 2025, volume 08 - Issue 14 Published by ValleyMedia, Inc. (ISSN 2836-7030)To subscribe to Healthcare Business ReviewVisit www.healthcarebusinessreview.com Disclaimer: *Some of the Insights are based on our interviews with CIOs and CXOs
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