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…
The Business Impact of EUDAMED on Market Access
The European Database on Medical Devices (EUDAMED) is often viewed by manufacturers purely as a compliance burden when…
MedEnvoy at RAPS Euro Convergence 2026
We are excited to share that MedEnvoy will be participating in RAPS Euro Convergence 2026 as an exhibitor! This year’s…
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 …
COFEPRIS Submission Mistakes That Delay Device Approvals
In 2025, Mexico’s COFEPRIS made major changes to its medical device regulatory process in which can produce common submission mistakes…
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…
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