Adverse Drug Reactions Monitoring System (ADRMS) User Manual for Stakeholders 

Adverse Drug Reactions Monitoring System (ADRMS)—a centralized digital platform designed to streamline Medical Device Adverse Event (MDAE) reporting for Market Authorization Holders (MAHs)

Key benefits of ADRMS:

• Simplified Reporting: Secure electronic submissions reduce manual errors.
• Easier Follow-up Data Submission: Simplified Follow-up data submission.
• Time & Cost Efficiency: Reduces manual documentation providing an online data submission and tracking.
• Regulatory Compliance: Enables timely, trackable, and compliant reporting.
• Data Security & Management: Encrypted data supports robust analysis and decision-making.