Navigating the Complexities of Latin America's Largest Healthcare Market

Brazil, the heart of Latin America, boasts a population of 214 million and ranks as the eighth largest healthcare market globally. With around 50% of medical devices and IVDs imported, Brazil presents a lucrative opportunity for global manufacturers. The country's recent legislative advancements further open its public tenders to international players, provided they align with local company processes.

Device Classification and Regulatory Pathways

Navigating Brazilian Regulations

Regulatory Authority

The Brazilian regulatory framework for medical devices is meticulously governed by ANVISA (National Health Surveillance Agency). Key regulations include Brazilian Good Manufacturing Practices (B-GMP) alongside comprehensive Notification and Registration processes and and Post-Market Surveillance. The Brazilian Good Manufacturing Practices (B-GMP) is valid for 2 years. However, the validity of the Brazilian Good Manufacturing Practices (B-GMP) certificate is extended to four years when granted through MDSAP (Medical Device Single Audit Program – Medical Devices Single Audit Program)

Classification

The National Health Surveillance Agency (ANVISA) classifies medical devices according to the risk they present. This classification is essential to determine the safety and efficacy requirements that each product must meet. The classification categories are Class I (Low Risk), Class II (Medium Risk), Class III (High Risk) and Class IV (Maximum Risk). Class I and II devices require only notification to ANVISA. With approval, the notification remains in force for an indefinite period. Class III and IV devices require B-GMP certification before a formal registration, with approval the registration is valid for 10 years.

Key Requirements

The journey to market medical devices involved comprehensive submissions to ANVISA, including detailed information about the device, clinical data, safety and efficacy studies, among others. This process also includes the marketing approval process and Post-Marketing Surevillance, which involves continous monitoring of the device's performance during its use. Data on adverse events, failures, and patient reactions are collected to ensure the safety, effectiveness, and high quality of medical devices throughout their life cycle.

Local representation is crucial, as it is mandatory to have a company with operating authorization from ANVISA  to commercialize medical devices in Brazil. This authorization is required for processes such as import, export,  manufacturing, distribution, storage, transport, and B-GMP.

Additionally, electromedical equipment must secure INMETRO certification, and devices with  telecommunications features require ANATEL certification, ensuring full compliance with Brazilian  regulations.

How We Can Help

Tailored Support for Market Entry

Leverage our expertise to simplify your entry into Brazil's healthcare market:

  • Classification and grouping of products to identify the regulatory pathway.

  • Compilation of the technical dossier for ANVISA registration.

  • Acting as your local representative for submission to ANVISA and coordinating certifications from INMETRO or ANATEL, as necessary.

  • Providing post-market surveillance and regulatory compliance support to ensure your success.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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