Brazil Medical Device Regulatory Strategy Report

Brazil is the largest market for medical devices in Latin America, attracting major attention from foreign manufacturers. The National Health Surveillance Agency Brazil (ANVISA) regulates Brazil’s medical device market, and all manufacturers must register their products with the agency prior to commercialization in Brazil.

ANVISA has established essential requirements for compliance similar to those developed in the European Union, and provides two major pathways to device approval: Notificação (low risk) and Registro (high risk). Notificação is simpler and faster, requiring only submission of the appropriate documents, while Registro requires ANVISA's approval. As of September 2020, the Cadastro pathway, which was formerly used for low-risk devices, is no longer effective.

Some medical devices require Brazil Good Manufacturing Practice (B-GMP) certification, as well.

Emergo can help you determine which of the above processes your device will fall under, as well as any additional requirements that will apply to your device. Additionally, we confirm the overall costs and timeline to market, so that you can pre-assess the requirements.

Let Emergo assist you in evaluating the Brazilian medical device regulatory framework as it applies to your device(s)

Emergo's Global Regulatory Overview Reports draw upon our worldwide network of consultants, industry resources and regulatory contacts in order to provide you with in-depth and accurate analysis on the medical device market in Brazil. Our Brazilian country report coverage includes:

  • ANVISA regulatory background
  • Product assessment based on Brazilian requirements
  • Device classification based on ANVISA criteria
  • Additional regulations which apply to your device
  • In-country representation in Brazil
  • Registro and/or Notificação registration requirements
  • Medical device labeling requirements
  • Costs and timeframes
  • Regulatory roadmap
  • Post-market surveillance requirements

Please contact us for more information about our Regulatory Overview Report for Brazil.

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