🇧🇷Brazil

Multas por Não-Conformidade com NR-12 e Rejeição de Produtos no Mercado

3 verified sources

Definition

NR-12 mandates compliance assessment including sample testing and market surveillance for machinery and equipment. Non-compliant products face rejection before commercialization. Additionally, under NR-12, the Brazilian License Holder (local representative) bears legal liability for recalls[4], creating financial exposure for non-compliance discovered post-sale.

Key Findings

  • Financial Impact: Estimated: R$ 150,000–500,000 per rejection cycle (product redesign, re-testing, market re-entry delays); Typical re-testing cost: R$ 20,000–80,000 per sample batch; Potential fine ranges: R$ 5,000–50,000 per non-conformity (based on Brazilian labor/safety penalty frameworks)
  • Frequency: Per product launch; 2–4 testing cycles typical for hardware achieving NR-12 compliance
  • Root Cause: Inadequate usability testing with disabled user groups during design phase; failure to validate accessibility prior to final certification

Why This Matters

The Pitch: Accessible hardware manufacturers in Brasil waste R$ 150,000–500,000 annually on product rejections, re-testing cycles, and market re-entry delays caused by inadequate usability testing protocols. Structured accessibility testing with disabled user groups eliminates costly compliance failures and accelerates time-to-market.

Affected Stakeholders

Product Engineering, Compliance & Certification, Brazilian License Holder / Local Distributor, Quality Assurance

Deep Analysis (Premium)

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

Multas e Impedimento de Comercialização por Violação da Lei de Inclusão (LBI 13.146/2015)

Estimated: R$ 200,000–1,000,000 per year (lost government tenders, B2B contract terminations); Typical discrimination lawsuit settlement: R$ 50,000–300,000; Reputational damage: 10–25% customer churn in enterprise segments

Atraso Regulatório em Aprovação de Dispositivos Assistivos (ANVISA Classe III/IV)

R$ 500,000–1,500,000 per product (12–24 month delay × average device wholesale value); 3,000–6,000 hours of compliance labor per product cycle

Carga Administrativa e Custos de Conformidade para Dispositivos 'Inovadores' (Classificação Incerta)

R$ 150,000–400,000 per product misclassification; 200–400 hours of compliance rework per product revision

Gargalo Operacional em Testes de Compatibilidade Local (Laboratórios Credenciados Limitados)

R$ 200,000–600,000 in lost revenue per product per quarter (due to delay); 300–800 hours of coordination labor per testing cycle

Multas por Descumprimento de Proteção de Dados (LGPD)

Up to 2% of annual Brazilian revenue per violation, capped at BRL 50 million (~USD 10.5 million) per violation[2][6][8]

Suspensão do CNPJ por Falha em Reportar Beneficial Owner (UBO)

Complete operational shutdown (estimated loss: 100% of daily revenue while suspended + costs to remediate and restore operations). Typical remediation: 5-15 business days

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