Melhores Advogados de Medicamentos e Dispositivos Médicos em São Paulo

1. About Medicamentos e Dispositivos Médicos Law in São Paulo, Brasil

Medicamentos e Dispositivos Médicos in Brazil are regulated primarily at the federal level. The national agency responsible for health surveillance and regulation is ANVISA, which classifies, registers, and monitors medicines and medical devices sold in the country.

In practice, residents of São Paulo must comply with federal rules when dispensing medicines or offering medical devices in clinics, pharmacies, or hospitals. State and local health authorities, including the Secretaria da Saúde do Estado de São Paulo, implement and enforce these rules in public sector settings and coordinate with private providers. This means that even when actions occur in São Paulo, the legal framework comes from federal legislation and ANVISA regulations.

Key regulatory features include device classification from Class I to Class III, registration or notification requirements, labeling in Portuguese, post-market surveillance, and adverse event reporting. The procurement of devices and medicines by public entities in São Paulo also falls under Brazil’s public procurement laws, which impact hospital purchases and vendor contracts.

“Medical devices in Brazil require registration with ANVISA and ongoing post-market surveillance.”

For official guidance, refer to the federal and state authorities that oversee these areas. ANVISA, at https://www.gov.br/anvisa, provides device classification and registration information. The Brazilian Ministry of Health at https://www.gov.br/saude offers broader health policy context, while the São Paulo state health site at https://www.saopaulo.sp.gov.br provides state-level procurement and health service considerations.

2. Why You May Need a Lawyer

Hospitals and clinics in São Paulo often rely on regulatory counsel to navigate complex registration, labeling, and post-market requirements for devices and medicines. An attorney can help ensure compliance with ANVISA rules and avoid recalls or penalties that disrupt patient care.

A hospital experiences a device recall and needs to manage communications with ANVISA, suppliers, and patients while minimizing liability. A lawyer helps coordinate the recall plan, document adverse events, and handle regulatory reporting timelines with precision.

A private distributor encounters unexpected regulatory action for a device’s labeling or packaging error. A legal counsel can assess the action, prepare corrective actions, and negotiate with the regulator to minimize penalties and delays in market access.

A healthcare provider seeks to participate in public procurement for devices under Lei 14.133/2021. An attorney can guide bid strategy, review contract terms, and ensure compliance with legal requirements for transparent, competitive processes.

A consumer in São Paulo sues a hospital for damages allegedly caused by a medical device. A lawyer is essential to analyze liability theories, evidence, and applicable consumer protection standards under Lei 8.078/1990, plus any contractual limitations.

For biomedical innovation startups in São Paulo, counsel can assist with device registration timelines, intellectual property considerations, and partnerships with research institutions. This helps align development efforts with regulatory milestones and funding timelines.

3. Local Laws Overview

Federal regulation governs medicines and medical devices in Brazil, with ANVISA administering registration, classification, labeling, and post-market surveillance. São Paulo state and municipal authorities implement and enforce these rules in public health facilities and procurement processes.

The following laws and statutes are central to the regulatory landscape in Brazil and São Paulo:

• Lei n° 6.360/1976 - Sanitary Control of Products and Services Subject to Sanitary Surveillance, including medicines, cosmetics, and medical devices. This law provides the framework for registration, surveillance, and control of health products. Effective since 23 September 1976, with ongoing updates through subsequent regulations.
• Lei n° 8.078/1990 - Código de Defesa do Consumidor (Consumer Protection Code). This federal law applies to patient claims, product safety, and service quality in health care contexts, including devices and medicines sold to consumers. In force since 1990 and widely applied across Brazil, including São Paulo.
• Lei n° 14.133/2021 - Lei de Licitações e Contratos Administrativos (Nova Lei de Licitações). This replaces parts of the old procurement regime, with implications for how São Paulo public health entities procure medicines and devices. Enacted in 2021, with gradual implementation across government agencies and adaptations for state procurement processes.

In addition to these statutes, the regulatory framework relies on ANVISA's regulatory actions, commonly issued as Resoluções de Diretoria Colegiada (RDCs). While specific RDC numbers may change, the overarching practice requires device registration, conformity assessment, labeling in Portuguese, and post-market vigilance. For current rules and guidance, consult ANVISA and state health authorities.

“Public procurement for health supplies in Brazil increasingly relies on the new Lei 14.133/2021, affecting how devices and medicines are acquired by São Paulo state entities.”

Key sources for São Paulo residents include:

• ANVISA - registration, classification, and post-market surveillance for medicines and devices.
• Ministério da Saúde - national health policy and regulatory context.
• Secretaria de Estado da Saúde de São Paulo - state-level procurement and health service administration guidance.

4. Frequently Asked Questions

What is the role of ANVISA in medical devices in São Paulo?

ANVISA classifies and registers medical devices, sets labeling requirements, and monitors post-market safety. São Paulo hospitals and clinics must follow these federal rules for any device used in care or sold to consumers.

How do I register a new medical device in Brazil?

Registration requires a technical dossier, device classification, evidence of safety and effectiveness, and Portuguese labeling. The process is handled through ANVISA, with documentation submitted for review and ongoing post-market obligations.

What is the typical timeline for device registration in Brazil?

Timelines vary by device class and completeness of the submission. Class I devices may be processed faster than Class II and III, which often require more data and audits from the manufacturer.

Do I need a São Paulo attorney for regulatory matters?

Not strictly, but a local attorney familiar with SP healthcare procurement and enforcement improves coordination with state authorities. A national regulatory attorney can handle registration, while local counsel manages state and municipal processes.

Is there a difference between registration and clearance for devices in Brazil?

Brazil uses registration and conformity assessments for devices, with post-market surveillance. Some fast-track pathways exist for lower-risk devices, but all must comply with ANVISA requirements and labeling standards.

What documents are usually required to register a device in Brazil?

Common documents include the technical file, risk classification, performance data, manufacturing site and GMP evidence, labeling in Portuguese, and distribution information. Additional data may be requested based on device class.

What should I know about labeling and packaging for devices sold in SP?

Labels must be in Portuguese and include safety warnings, lot numbers, and instructions for use. Packaging should meet regulatory requirements to ensure traceability and safe handling in health facilities.

Can I challenge a regulatory decision by ANVISA in São Paulo?

Yes, there are administrative appeals and judicial review options. Deadlines apply, so timely legal guidance is important to preserve rights and remedies.

How long does a recall process typically take in São Paulo?

Recall timing depends on the risk level, device class, and regulatory coordination. A recall plan usually includes public notices, supplier cooperation, and corrective actions coordinated with ANVISA.

What should a hospital do after a device adverse event is reported?

Document the event, notify ANVISA, and review internal quality and safety processes. Transparent reporting helps mitigate liability and supports a timely regulatory response.

What is the difference between an AEM and a CEM in device regulation?

In Brazil, post-market surveillance is centralized under ANVISA with adverse event reporting. The terms vary by context; your attorney can translate responsibilities for your specific device category.

Do consumer protections apply to devices bought in clinics and pharmacies in SP?

Yes. The Consumer Protection Code governs safety and quality expectations for consumer purchases, and patients may seek remedies for damages caused by defective devices or medicines.

5. Additional Resources

• ANVISA - Official regulator for health products including devices and medicines. Function: registration, classification, labeling, post-market surveillance. https://www.gov.br/anvisa
• Ministério da Saúde - National health policy and regulatory guidance. Function: policy development, health system funding, and public health programs. https://www.gov.br/saude
• Secretaria de Estado da Saúde de São Paulo - State-level health administration and procurement. Function: hospital licensing, distribution of health resources, and compliance at the state level. https://www.saopaulo.sp.gov.br

6. Next Steps

1. Define your regulatory objective and timeline. Determine if you are registering a device, seeking recall guidance, or pursuing a procurement contract in SP.
2. Identify the scope of the issue. Gather device specifications, registration numbers, packaging, labeling, and any adverse event data.
3. Consult a lawyer with experience in Medicamentos e Dispositivos Médicos in São Paulo. Prefer counsel who can coordinate with ANVISA and SES-SP as needed.
4. Prepare a discovery plan. List all documents to request from manufacturers, suppliers, and healthcare facilities, including technical dossiers and quality certifications.
5. Request an initial consultation and feasibility assessment. Ask for a written engagement letter outlining scope, fees, and timelines.
6. Review procurement options under Lei 14.133/2021. If government contracts are involved, ensure compliance with bidding and contract requirements.
7. Implement a formal compliance program. Establish labeling, post-market surveillance, adverse event reporting, and recall procedures in collaboration with your attorney.