ANVISA GMP Inspections (Inspeções Sanitárias)
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ANVISA and state VISA bodies conduct inspeções sanitárias (health surveillance inspections) of medical device manufacturers and importers. These inspections may be scheduled (routine) or unannounced (surprise) and may be triggered by adverse event reports, recalls, complaints, or random selection.
Types of ANVISA inspections
| Type | Description |
|---|---|
| Routine inspection | Scheduled inspection for CBPF issuance or renewal |
| Surveillance inspection | Periodic check on a licensed manufacturer/importer |
| Unannounced inspection | Triggered by adverse events, recalls, or complaints — no advance notice |
| Foreign inspection | ANVISA may inspect foreign manufacturer sites, particularly for Class IV devices |
The inspection process
- Opening meeting — inspectors present and review inspection scope.
- Documentation review — quality system documents, SOPs, records.
- Facility walk-through — production areas, warehouse, cleanrooms, laboratories.
- Personnel interviews.
- Closing meeting — inspectors summarise findings.
- Inspection report — issued by ANVISA with any non-conformities.
- Corrective action — manufacturer responds to non-conformities within the stated timeframe.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.