Why Post-Market Surveillance is a Strategic Priority for Medical Device Companies in Egypt?
For medical device manufacturers and importers, obtaining market approval is only the starting point. In Egypt, the Egyptian Drug Authority (EDA) closely monitors the performance and safety of medical devices once they reach the market. This makes a structured Post-Market Surveillance (PMS) system not just a regulatory obligation, but a strategic necessity.
Effective Post-Market Surveillance safeguards patient safety, controls operational and reputational risks, preserves product approvals, and strengthens a company’s market presence. In Egypt’s competitive healthcare sector, manufacturers that actively manage PMS achieve operational continuity, regulatory security, and sustained business growth.
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What is Post-Market Surveillance for Medical Devices?
Post-Market Surveillance refers to the continuous process of collecting, analyzing, and evaluating data on the safety and performance of a medical device once it has been made available in the market. It enables manufacturers to identify potential risks, detect patterns in adverse events, and take corrective or preventive actions as necessary.
According to EDA guidelines, a structured PMS program is mandatory for all medical devices registered in Egypt. This ensures that devices remain safe and effective throughout their lifecycle and that any emerging risks are promptly identified and managed.
Key EDA Requirements for Post-Market Surveillance in Egypt
To comply with EDA regulations, medical device companies must implement several PMS activities tailored to their product’s risk classification and market exposure.
Post-Market Surveillance Plan (PMS Plan)
Every medical device must be supported by a documented PMS Plan. This plan outlines the methodology for collecting, analyzing, and assessing post-market data related to the device. It should specify data sources, data collection frequency, risk management procedures, and methods for evaluating and reporting identified trends.
For higher-risk devices (Class C and D), EDA expects a detailed PMS strategy submitted during the registration process and regularly updated based on market data.
Adverse Event Reporting and Vigilance
Manufacturers and importers must establish an adverse event reporting and vigilance system. This process ensures that any serious incidents or product-related issues are reported to EDA within specified timelines, typically ranging from 2 to 30 days, depending on the severity of the event.
Each report must include a description of the incident, product details, patient outcomes, root cause investigation findings, and corrective actions taken to prevent recurrence.
Periodic Safety Update Reports (PSUR)
For high-risk devices, manufacturers are required to prepare and submit Periodic Safety Update Reports (PSUR) to EDA at regular intervals. These reports provide an overview of the device’s performance, a summary of adverse events, corrective actions undertaken, benefit-risk updates, and recommendations for product improvements or safety enhancements.
Documentation and Record Keeping
All PMS activities, including plans, reports, adverse event records, corrective actions, and feedback logs, must be properly documented and maintained. EDA may request these records during audits or post-market inspections to verify regulatory compliance.
How Can Operon Strategist Help You with Post-Market Surveillance in Egypt?
Operon Strategist is a trusted regulatory partner with over a decade of experience in managing Post-Market Surveillance (PMS) for medical device companies in Egypt. Our team ensures full compliance with EDA guidelines while helping businesses maintain market approvals and minimize risks.
We support with:
EDA-compliant PMS Plans
Vigilance and adverse event reporting
PSUR preparation for Class C & D devices
CAPA management
Audit and inspection support
Work with us to streamline your PMS processes and stay compliant in Egypt’s regulated market.