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NOTIVISA & Post-Market Vigilance
Post-Market Surveillance & Tecnovigilância (Brazil)
Tecnovigilance is ANVISA's post-market surveillance system for adverse events and technical complaints involving medical devices and IVDs. Market authorization does not end the regulatory obligation; the Brazilian holder and manufacturer must be able to detect safety signals, investigate complaints, implement corrective action and execute field actions when necessary.
When This Support Is Needed
Medical devices or IVDs are actively commercialized in Brazil requiring formal post-market oversight
A serious adverse event, patient injury, or critical technical complaint has occurred in Brazil or globally
A global recall, field safety corrective action (FSCA), or safety alert affects Brazilian distributed units
ANVISA issues an official post-market audit notice or requests complaint investigation data
What We Challenge Before Submission
Is the technical complaint or adverse event reportable under Brazilian tecnovigilância timelines?
Does a global corrective action or safety notice apply to the Brazilian product population?
Are investigation conclusions supported by objective pre-clinical and engineering evidence?
Has the device risk management file been updated with newly detected post-market hazards?
Are field-action customer communications and affected-lot traceability fully documented for ANVISA?
Our Tecnovigilância Support Scope
Post-market surveillance (PMS) system review and Brazilian standard operating procedure setup
Customer complaint intake, triage, and technical defect classification
Adverse-event and technical-complaint reportability assessment under ANVISA regulations
Manufacturer-to-Brazilian-Holder (BRH) escalation and communication workflow implementation
Investigation, root-cause analysis, and engineering evidence review
Risk-management file feedback and ISO 14971 residual risk re-evaluation
CAPA linkage, corrective action execution, and effectiveness verification
ANVISA electronic notification via NOTIVISA and Formulário de Tecnovigilância
Field Safety Corrective Action (FSCA) strategy, customer health alerts, and recall execution
Global safety signal assessment and Brazilian population risk evaluation
Corrective labeling, packaging artwork, and IFU warning updates following safety findings
Annual post-market trend analysis and safety surveillance report authoring
Connected Vigilance Chain:
We connect the post-market chain rather than treating each complaint as an isolated record: Complaint / Event → Investigation → Risk → CAPA → Field Action / Reporting → Technical Documentation and Labeling Update.
Maintain Rigorous Tecnovigilância and Post-Market Compliance
Our vigilance specialists evaluate incident reportability, lodge NOTIVISA notifications, and coordinate recall actions with ANVISA.