Swissmedic Launches 2026 PMS Focus Campaign for Higher-Risk Medical Devices
Swissmedic has issued a formal information letter announcing that it will conduct a focus campaign in 2026 reviewing post-market…
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TGA Clarifies Exclusion for Digital Mental Health Software
The Australian Therapeutic Goods Administration (TGA) published guidance on 16 March 2026 clarifying when software products intended to…
FDA Reclassifies Two Skin Cancer Diagnostic Devices
The Food and Drug Administration (FDA) issued a final order on March 25, 2026 reclassifying two types of skin-cancer-related…
EU Classification Guidance Updated: Borderline Manual and MDCG 2021-24
The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are qualified…
Key FDA Changes MedTech Manufacturers Need to Know
The FDA has issued an update for MedTech Manufacturers to its List of FDA-Recognized Consensus Standards, published as …
Changes to Health Canada Medical Device Applications
Health Canada has issued several guidance documents that take effect in early 2026 and will directly impact how medical device applications must…
FDA Guidance on General Wellness: Policy for Low-Risk Devices
The FDA released a revised final version of its guidance, General Wellness: Policy for Low Risk Devices, on January 6, 2026.
FDA Final Guidance: Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) released an updated final guidance document titled “…
FDA Transitions to QMSR: Immediate Actions for Manufacturers
Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System Regulation…
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