Preparing Medical Device Vigilance Reports

On your behalf we fulfill your responsibility for the safety requirements of medical devices in accordance with Procedures and Principles Regarding Medical Device Alert Notification System, under the following headings.


  • Alert Tracking System services
    • Adverse events
    • Receipt of the report, following up to complete the missing parts
    • Assesment and ve decision about reporting
    • Reporting
    • Submission
    • Follow up
    • Reportings
    • Preparation of report for electronic submission on alert system
    • Manufacturer Adverse Event Reports
    • Field Safety Corrective Action Report
    • Field Safety Report Attachment
    • Preparation of dossiers
    • Submission to the Agency
    • Corrective actions
    • Planning
    • Consensus with the Ministry of Health
    • Information letter preparation/distribution
    • Execution