Articles by Julio G. Martinez-Clark

  1. Chile's Easy Market Ends In 2028 9/11/2026

    For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date. High-risk, technically complex products will be the most affected by a new decree.

  2. Spanish Is Not One Regulatory Language 9/4/2026

    Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?

  3. When ANVISA's Clock Runs Out 7/30/2026

    In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.

  4. Why Your LATAM Authorized Representative Strategy Is A Market Entry Decision, Not A Clerical One 6/18/2026

    Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset becomes the operational choke point for importation, renewals, and more.

  5. The QMSR's Hidden ROI: LATAM's Device Trial Advantage 5/18/2026

    The FDA's new QMSR quietly created a harmonized quality framework between the U.S. and Latin America. With high recruitment performance and low cost, conducting medtech trials in the region has key benefits.

  6. New Sustainability Mandates In Brazil And Chile Are Quietly Disqualifying Medical Devices 4/15/2026

    The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment; it represents a structural market transformation. 

  7. The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail 2/20/2026

    While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

  8. Navigating Brazil's Medical Device Clinical Trial Import Process 1/27/2026

    When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

  9. The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America 1/13/2026

    Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.

  10. Beyond Recruitment: A Practical ROI Model For Integrating Community Health Workers Into Medtech Trials 10/22/2025

    The medtech industry desperately needs — and currently lacks — a practical trial-specific financial framework to build a compelling business case for community health workers.