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…
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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,…
FDA Final Guidance: Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) released an updated final guidance document titled “…
EUDAMED & swissdamed: Mandatory Registration for 2026
Preparing for EUDAMED & swissdamed As global regulatory systems continue evolving, medical device manufacturers must stay ahead of changing…
FDA Transitions to QMSR: Immediate Actions for Manufacturers
Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System…
EUDAMED Registration Mistakes and How to Avoid Them
The European Database on Medical Devices (EUDAMED) is a centralized electronic system established…
FDA Guidance on Cuffless Blood Pressure Measuring Devices
The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance…
World Health Expo Dubai 2026
Schedule a Meeting at WHX Dubai 2026 MedEnvoy at WHX Dubai 2026 MedEnvoy…
EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market…
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