Julio G. Martinez-Clark

ARTICLES BY JULIO G. MARTINEZ-CLARK

• 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.

• 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.

• 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.

• 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. 

• 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.

• 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.

• 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.

• 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.

• The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device

  10/3/2025

  The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

• Emerging Markets Are Pioneering Hybrid Clinical Trial Models For Medtech Products

  8/25/2025

  This article shares insights into how Latin America, southeast Asia, and Africa are pioneering hybrid clinical trial models for medtech products.