🇧🇷Brazil

Multas ANVISA por Venda Irregular de Lentes Corretivas

3 verified sources

Definition

Regulation forbids sale of corrective lenses outside specialized licensed shops; importers need ANVISA import licenses. Non-compliance results in penalties from ANVISA, classified as severe for post-market surveillance failures.

Key Findings

  • Financial Impact: R$5,000+ fine per violation (typical ANVISA penalty range); up to 20% gross revenue for related antitrust breaches
  • Frequency: Per irregular sale or import batch
  • Root Cause: Manual process lacks automated checks for shop licensing, import licenses, and state health surveillance registration

Why This Matters

The Pitch: Optometrists in Brasil waste R$10,000+ annually on ANVISA penalties. Automation of license verification and NF-e issuance eliminates this risk.

Affected Stakeholders

Proprietários de Óticas, Gerentes de Compras, Importadores de Lentes

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

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