Post-Market Surveillance (PMS) refers to the mandatory regulatory process of monitoring the safety, quality, and performance of medical devices after they are placed on the market. In the United Arab Emirates, PMS is a legal requirement enforced by the Ministry of Health and Prevention (MOHAP) to ensure that medical devices continue to meet safety and performance requirements throughout their lifecycle.
PMS allows regulatory authorities and manufacturers to identify device malfunctions, safety risks, or performance issues and implement corrective actions when necessary. Compliance with PMS requirements is essential to maintain medical device registration and continued market access in the UAE.
Legal Responsibility for PMS Compliance
Manufacturer Responsibilities
Medical device manufacturers are primarily responsible for establishing and maintaining a Post-Market Surveillance system. This includes actively monitoring device performance, identifying safety issues, and ensuring timely reporting to UAE authorities.
Manufacturers must:
Establish a documented PMS system
Monitor device performance continuously
Maintain complaint and incident records
Investigate adverse events and device failures
Implement corrective and preventive actions (CAPA)
Ensure timely reporting of serious incidents
These obligations apply to all medical devices registered and marketed in the UAE.
Authorized Representative Responsibilities
Foreign manufacturers must appoint a UAE Authorized Representative to fulfill local regulatory obligations. The Authorized Representative serves as the official point of contact with MOHAP and supports PMS compliance activities.
Key responsibilities include:
Reporting incidents and safety concerns to MOHAP
Maintaining complaint and vigilance records
Coordinating Field Safety Corrective Actions (FSCA)
Supporting recall management
Ensuring regulatory communication compliance
The Authorized Representative plays a critical role in ensuring timely regulatory reporting.
PMS System Requirements
Manufacturers must implement a formal PMS system as part of their Quality Management System. This system must be documented and available for regulatory inspection.
A compliant PMS system includes:
1. PMS Plan
The PMS Plan defines how post-market data will be collected, reviewed, and analyzed. It must describe procedures for complaint handling, incident reporting, and risk evaluation.
The PMS Plan ensures that manufacturers have a structured and proactive approach to monitoring device safety.
2. Complaint Handling System
Manufacturers must maintain a formal complaint handling procedure to receive, document, and evaluate complaints related to device performance or safety.
Complaint handling procedures must include:
Recording and documentation of complaints
Technical investigation of device issues
Identification of root causes
Implementation of corrective actions
All complaints must be evaluated to determine whether regulatory reporting is required.
3. Vigilance Reporting Obligations
Vigilance reporting is a critical PMS requirement in the UAE. Manufacturers must report serious incidents involving medical devices to MOHAP.
Reportable incidents include:
Device malfunctions that could cause harm
Serious injury or death associated with device use
Safety-related defects
Any event requiring corrective action
Timely vigilance reporting ensures that regulatory authorities can take appropriate measures to protect public health.
4. Field Safety Corrective Actions (FSCA)
When a safety issue is identified, manufacturers must implement corrective actions to reduce or eliminate the risk. These actions are known as Field Safety Corrective Actions.
Examples include:
Product recalls
Software corrections
Safety notices
Labeling updates
Manufacturers must notify MOHAP and ensure corrective actions are implemented effectively.
5. Medical Device Recall Requirements
If a medical device presents a safety risk, manufacturers must initiate a recall and notify regulatory authorities.
Recall procedures must include:
Identification of affected devices
Notification to distributors and users
Removal or correction of affected products
Submission of recall reports to MOHAP
Manufacturers must maintain documented recall procedures.
6. Record Keeping and Traceability
Manufacturers and Authorized Representatives must maintain detailed records related to PMS activities. These records must be available for regulatory review.
Required records include:
Complaint records
Incident reports
Investigation reports
Corrective action records
Distribution and traceability records
Traceability ensures efficient recall and risk management.
Regulatory Reporting and Documentation Requirements
Manufacturers must maintain documentation demonstrating compliance with PMS obligations. This documentation may be reviewed during regulatory audits or inspections.
Key documentation includes:
PMS Plan
Complaint handling procedures
Vigilance reporting records
Corrective action reports
Recall procedures
Investigation reports
Proper documentation is essential for demonstrating regulatory compliance.
Impact of PMS on Medical Device Registration in UAE
Post-Market Surveillance is directly linked to maintaining medical device registration in the UAE. Failure to comply with PMS requirements may result in regulatory actions, including:
Suspension of product registration
Product recall or withdrawal
Regulatory penalties
Restrictions on market access
Maintaining an effective PMS system ensures continued regulatory approval.
How OMC Medical Supports PMS Compliance in UAE
OMC Medical assists manufacturers in meeting UAE Post-Market Surveillance requirements by providing regulatory support and compliance services.
Our support includes:
PMS system implementation
Vigilance reporting assistance
Complaint handling system setup
Recall and FSCA support
Authorized Representative services
We ensure manufacturers remain compliant with UAE medical device regulations.
Conclusion
Post-Market Surveillance is a mandatory regulatory requirement for medical devices in the UAE. Manufacturers must implement structured PMS systems, monitor device performance, report incidents, and take corrective action when required.
Compliance with PMS obligations ensures patient safety, regulatory compliance, and continued market access in the UAE.
