ANVISA Inspection Types & Authority
ANVISA and state VISA bodies have broad inspection powers under Lei 9.782/1999 and Lei 6.437/1977. ANVISA inspectors may inspect any facility engaged in the manufacture, import, distribution, or storage of medical devices in Brazil, with or without advance notice.
Types of ANVISA inspections
| Type | Description | Triggered by |
|---|---|---|
| Routine GMP inspection (inspeção de BPF) | Scheduled inspection for CBPF issuance or renewal | CBPF application |
| Surveillance inspection (inspeção de vigilância) | Periodic compliance check | Random selection or risk-based schedule |
| Unannounced inspection (inspeção não anunciada) | No advance notice | Adverse events, complaints, post-market signals |
| Cause-based inspection (inspeção por causa) | Triggered by specific event | Recall, serious adverse event, public complaint |
| Market surveillance inspection | Sampling of products from market | Risk-based or random |
| Foreign inspection | Inspection of overseas manufacturer | Class IV devices; specific safety concerns |
ANVISA's inspection authority
ANVISA inspectors are empowered to:
- Enter and inspect any facility subject to health surveillance regulation;
- Examine records, quality systems, and production processes;
- Collect samples of products for laboratory testing;
- Issue interdiction orders (apprehension of products or closure of facilities); and
- Issue auto de infração (infraction notices) leading to fines and other penalties.
Preparing for an ANVISA inspection
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Maintain a current and documented GMP compliance programme at all times, with records demonstrating continuous compliance — do not treat inspections as isolated events. A robust quality system should be your baseline operating standard, not a preparation activity.
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Ensure all required documents are readily accessible: AFE, CBPF certificate, batch records, NOTIVISA reports, CAPA records.
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Brief the Responsável Técnico on their role as the primary contact for ANVISA inspectors.
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Conduct regular internal audits using ANVISA's inspection checklist as a reference.
Verify all information against official ANVISA sources before making regulatory decisions.
"Products collected during market surveillance inspections are submitted to ANVISA laboratories for testing and analysis. If non-conformities are detected, the registration holder is notified and enforcement action may be initiated, ranging from corrective action requests to seizure or registration cancellation."
"Organize batch records, complaint handling logs, CAPA documentation, and non-conformance reports by date and device for quick retrieval. Ensure all required signatures, approvals, and timestamps are present in quality system documentation."