Regulatory intelligence
insights & analysis.
Expert analysis of global regulatory trends, data-driven insights, and industry perspectives.
FDA's Evolving AI/ML Framework: What Device Makers Need to Know
The FDA's updated predetermined change control plan (PCCP) guidance reshapes how AI-enabled medical devices can iterate post-market. We break down the key changes and what they mean for your regulatory strategy.
EU MDR Three Years In: Winners, Losers, and the Data Behind the Transition
With legacy device deadlines now passed, our data reveals which product categories saw the highest attrition, where notified body bottlenecks hit hardest, and which manufacturers gained market share.
NMPA's Fast-Track Pathway: A New Route Into China's $45B Device Market
China's NMPA introduced an expedited review channel for innovative devices in Q1 2026. We analyze early adoption data, approval timelines, and how this compares to FDA Breakthrough designation.
Global Recall Patterns Q1 2026: Signals From 27 Regulators
Our analysis of 2,400+ recall actions across 27 regulatory agencies reveals emerging patterns in software-related recalls, a spike in IVD corrections, and geographic clustering of supply-chain-driven events.
Medical Device Supply Chain Under Pressure: Tariff Impacts and Mitigation Strategies
Escalating trade tensions are reshaping medical device supply chains. We map the tariff exposure across device categories and identify the dual-sourcing strategies leading manufacturers are adopting.
Regulatory Harmonization Progress: MDSAP, IMDRF, and the Path to Mutual Recognition
Cross-border regulatory alignment is accelerating. We assess MDSAP audit data, IMDRF convergence initiatives, and what the latest bilateral agreements mean for global market access timelines.
Cybersecurity Requirements for Connected Devices: A Cross-Market Comparison
FDA, EU, and NMPA are all tightening cybersecurity expectations for connected medical devices. We compare pre-market requirements, post-market obligations, and the emerging consensus on SBOM mandates.
Post-Market Surveillance Is Getting Smarter: Real-World Data Trends in 2026
Regulators are increasingly expecting real-world evidence for device performance monitoring. We examine how FDA, EMA, and PMDA are leveraging registry data, and what this means for PMS system design.
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