Medical Device
European Medicines Agency – Explanatory Note on Implementation of ICH Q12 Guideline
Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices
USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s
FDA Bans Electrical Stimulation Devices Used for Self-injurious Behavior or Aggressive Behaviour
Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets
TGA: Regulatory Impact Statement – Proposed Regulatory Scheme for Personalised Medical Devices, Including 3D-Printed Devices
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