ANVISA GMP Inspections (Inspeções Sanitárias)
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.
Verify all information against official ANVISA sources before making regulatory decisions.
Routine CBPF inspections are conducted every 2 years for renewal purposes. Surveillance inspections may be conducted at any time based on ANVISA's risk assessment and inspection history. Inspections may be triggered by adverse event reports, product recalls, customer complaints, previous inspection non-conformities, product complaints from users or healthcare providers, regulatory actions in other jurisdictions, or random selection based on device risk classification (Class III and IV devices are subject to more frequent risk-based surveillance).
Surveillance inspection frequency is risk-based and determined by device classification and ANVISA's compliance history assessment. Class III and Class IV devices may be subject to more frequent inspections. State VISA bodies may conduct additional inspections in their jurisdictions based on local regulations.
Routine CBPF inspections are generally conducted every 2 years for renewal purposes. Surveillance inspections may be conducted at any time based on ANVISA's risk assessment. Inspections may be triggered by adverse event reports, product recalls, customer complaints, previous inspection non-conformities, or random selection based on device risk classification.