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SFDA Vigilance & FSCA
Post-Market Surveillance, Vigilance & Field Safety Actions (SFDA)
MDMA Approval Creates Ongoing Safety and Surveillance Obligations. SFDA regulates the complete device lifecycle, including post-market surveillance, incident management, safety signals and field actions. Manufacturers and their Saudi regulatory interfaces must have processes to identify, investigate, assess and communicate safety issues after commercialization.
When This Support Is Needed
Medical devices or IVDs are actively commercialized in Saudi Arabia requiring statutory post-market oversight
A serious adverse event, patient injury, or technical malfunction occurs within the Kingdom or overseas
A global Field Safety Corrective Action (FSCA), product recall, or customer safety notice affects Saudi inventory
SFDA issues a post-market safety inquiry or requests root-cause investigation records
What We Challenge Before Submission
Is the incident reportable to the SFDA within statutory time limits (e.g. 2 days for public health threats, 10 days for death/serious injury)?
Does a global corrective action or recall notice apply to devices distributed in the Saudi market?
Are investigation conclusions substantiated by objective pre-clinical or failure analysis data?
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 the SFDA?
Our Post-Market & Vigilance Support Scope
Post-Market Surveillance (PMS) system and procedure setup aligned with SFDA regulations
Customer complaint intake, triage, and adverse event reportability assessment
Direct electronic incident reporting to the SFDA National Pharmacovigilance and Device Center
Manufacturer-to-Authorized-Representative (AR) emergency 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 Arabic and English formats for healthcare providers
Global safety signal evaluation and risk assessment for the Saudi patient population
Risk management file and labeling updates following post-market safety findings
Coordination with local commercial importers, distributors, and healthcare facilities
Lifecycle Data Loop:
We connect Complaint / Incident -> Investigation -> Risk -> CAPA -> FSCA / Reporting -> Technical File / Labeling Update. This allows post-market data to feed the lifecycle evidence rather than sit outside it.
Maintain Rigorous SFDA Post-Market Vigilance and Recall Preparedness
Our vigilance specialists evaluate incident reportability, lodge SFDA notifications, and coordinate Field Safety Corrective Actions.