Post-Market Monitoring, Vigilance & Field Actions (UAE)

Registration Creates Ongoing Safety and Market-Surveillance Responsibilities. Post-market monitoring should connect complaints, adverse events, safety signals, manufacturer investigations, corrective actions, overseas regulatory actions and local communications. MOHAP's registration requirements explicitly include post-marketing monitoring expectations.

Strengthen Your UAE Post-Market System

When This Support Is Needed

Medical devices, equipment, or IVDs are actively marketed in the UAE requiring statutory post-market vigilance

A serious adverse event, patient injury, or technical malfunction occurs within the UAE or overseas

A global Field Safety Corrective Action (FSCA), product recall, or customer safety notice affects UAE inventory

MOHAP issues a post-market safety inquiry or requests root-cause investigation records

What We Challenge Before Submission

Is the adverse incident reportable to MOHAP within statutory time limits?

Does a global corrective action or recall notice apply to devices distributed in the UAE?

Are investigation conclusions substantiated by objective laboratory data or design history records?

Has the device risk management file been updated with newly detected post-market failure modes?

Are field action communications and affected batch/serial traceability completely documented for MOHAP inspectors?

Our Post-Market & Vigilance Support Scope

Post-Market Surveillance (PMS) system and procedure setup aligned with MOHAP regulations

Customer complaint intake, triage, and adverse event reportability assessment

Direct electronic incident reporting to the MOHAP Pharmacovigilance and Medical Device Section

Manufacturer-to-Licensed-Medical-Warehouse communication and escalation pathways

Root-cause investigation, engineering failure analysis, and CAPA formulation

Periodic Safety Update Reports (PSUR) and Post-Market Clinical Follow-up (PMCF) report authoring

Field Safety Corrective Action (FSCA) strategy, recall execution, and quarantined product governance

Field Safety Notice (FSN) drafting in bilingual English and Arabic formats for UAE healthcare providers

Global safety signal evaluation and risk assessment for the UAE healthcare sector

Risk management file and labeling updates following post-market safety findings

Coordination with local commercial importers, distributors, and private/public healthcare entities

Lifecycle Surveillance Integration:

We connect Complaint / Incident -> Investigation -> Risk -> CAPA -> Field Action / Reporting -> Technical File / Labeling Update. This keeps post-market information inside the regulatory lifecycle instead of treating vigilance as a stand-alone administrative task.

Maintain Seamless MOHAP Post-Market Vigilance and Recall Preparedness

Our vigilance team evaluates incident reportability, coordinates Field Safety Notices, and manages regulatory reporting in the UAE.

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