Regulatory & Compliance Perspectives

  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. Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide 8/31/2026

    This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

  4. Don't Lose Sight Of Ophthalmic Injectables' Regulatory Complexity 8/17/2026

    Intravitreal injectables face some of the strictest regulatory scrutiny in drug development. Learn what sponsors need to know about EU GMP Annex 1, USP standards, and container closure integrity to stay compliant.

  5. Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments 8/3/2026

    India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.

  6. 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.

  7. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

  8. 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.

  9. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

  10. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

    Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.