Biological Evaluation
Conducting a biological evaluation is a critical step for manufacturers aiming to register a medical device in Brazil. Regulated by Anvisa (the Brazilian Health Regulatory Agency), this process ensures that all safety and performance requirements are met in accordance with both national regulations and international standards, particularly ISO 10993.
For companies looking to introduce products into the Brazilian market, understanding and properly implementing the biological evaluation of medical devices is essential—not only for compliance, but also for risk mitigation and global market access.
How We Support Your Biological Evaluation in Brazil
Our team offers specialized support in preparing and structuring documentation for the biological evaluation in Brazil, fully aligned with Anvisa’s current framework and ISO 10993 series guidelines.
Key components of our service include:
Biological Evaluation Plan (BEP): Defines the strategy for assessing the biological safety of the device, including its identification, categorization, and the documents to be produced throughout the evaluation process.
Biological Evaluation Report (BER): Presents a complete risk analysis using all available data—such as material characterization, manufacturing processes, global use history, and relevant clinical or preclinical data. When necessary, we also guide the selection of additional biological tests.
Material Characterization: Compilation and organization of information about the device’s materials, including chemical and physical properties and their potential biological interactions.
Gap Identification and Risk Management: Assessment of available data to identify gaps, evaluate residual risks, and recommend next steps in accordance with ISO 10993 and Anvisa’s RDC 848/2024.
Our service ensures that your documentation is organized, technically sound, and ready for submission—minimizing delays and reducing the risk of non-compliance.
Why do you need this service?
Alignment with Anvisa regulations and ISO 10993 standards—mandatory for market access in Brazil.
Evaluate risks such as toxicity, irritation, and sensitization to support the safety profile of your medical device.
Early biological evaluation provides valuable insights for choosing materials and defining product design.
With experience in both local and international regulatory frameworks, our team supports the full biological evaluation of medical devices submitted to Anvisa. We help you align your documentation with Brazilian expectations while maintaining consistency with global standards like ISO 10993.
From initial planning to report delivery, we focus on technical precision, clear communication, and a regulatory strategy tailored to your product’s profile.
Need help with your biological evaluation?
Whether you’re registering a new medical device or updating an existing submission, our team is ready to support your biological evaluation Anvisa process.
Contact us today to ensure your medical device meets all safety, performance, and regulatory expectations for the Brazilian market.
