Alerts
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Recent Alerts
FDA 510(k) GAMP Framework Updated
NEW
New premarket submission requirements for AI-enabled medical devices with enhanced cybersecurity provisions
🇺🇸 United States•2 hours ago
EMA Digital Health Technology Guidance
European Medicines Agency published comprehensive guidance on digital health technologies
🇪🇺 European Union•1 day ago
ISO 13485 Clinical Investigation Amendment
Updated clinical investigation requirements for medical devices - Amendment 7 2024 published
🌍 Global•3 days ago
China NMPA Class II Device Registration Update
New requirements for Class II medical device registration and technical documentation
🇨🇳 China•5 days ago
Japan PMDA Software as Medical Device Guidelines
Updated guidelines for software as medical device (SaMD) approval pathway
🇯🇵 Japan•1 week ago
Health Canada Medical Device Regulations Amendment
Amendments to medical device regulations for Class III and IV devices
🇨🇦 Canada•1 week ago
FDA Cybersecurity in Medical Devices - Final Guidance
Final guidance on cybersecurity for networked medical devices
🇺🇸 United States•2 weeks ago
MHRA Post-Brexit Medical Device Regulation
Updated UK medical device regulation framework post-Brexit transition
🇬🇧 United Kingdom•2 weeks ago