Regulatory & Compliance Perspectives

1. The Post-Trial Access Trap Medtech Sponsors Ignore In Latin America 11/9/2026

   How many Latin American countries have made the post-trial provisions (per the 2024 Word Medical Association Declaration of Helsinki) binding for medical devices? Let's take a closer look at nuances country-by-country.

2. The Standard You Stopped Reading In 1996 Just Rewrote Your 2030 Audit 11/2/2026

   On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we live in ISO 13485. That shrug is a mistake.

3. Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations 10/15/2026

   The advice handed to medtech companies planning a first-in-human (FIH) study has been: go to Australia. That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed.

4. Everyone Is Only Reading The MDR Half Of Europe's Reform 9/21/2026

   The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.

5. 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.

6. 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?

7. 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.

8. 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.

9. 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.

10. 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.