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 GMP/CBPF compliance programme at all times — do not treat inspections as isolated events.
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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.