Regulatory & Compliance Perspectives

1. Don't Lose Sight Of Opthalmic Injectables' Regulatory Complexity 8/12/2026

   Evolving regulatory guidance surrounding intravitreal therapies is providing drug developers with greater clarity about expectations from components sourcing and production to final packaging.

2. 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.

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. 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.

5. 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.

6. 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.

7. 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.

8. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

   The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

9. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

   FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

10. 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.