Biological Evaluation

Biological Evaluation for Medical Devices in Brazil

The biological evaluation of medical devices in Brazil is critical for ensuring safety and regulatory compliance. Governed by ANVISA, the Brazilian Health Regulatory Agency, this evaluation aligns with the ISO 10993 series, ensuring international standards are met.

Regulatory Framework

The regulatory framework in Brazil is defined by ANVISA’s RDC 546/2021, which outlines essential safety and performance requirements. Moreover, it incorporates elements from ISO 10993-1:2018, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Evaluation Process

Our evaluation process involves a thorough analysis of the medical device’s biological safety, including material characterization and risk management. Additionally, adherence to ISO 10993 ensures global compatibility and acceptance. ANVISA collaborates with international bodies to harmonize these standards effectively.

Documentation Requirements

Manufacturers must submit detailed documentation to ANVISA, including:

  • Biological Evaluation Plan: This plan outlines the strategy for assessing the biological safety of the device, referencing relevant ISO 10993 standards.
  • Biological Evaluation Report: This report summarizes the findings from the evaluation and demonstrates compliance with ISO 10993 requirements.
  • Material Characterization: Detailed information about the materials used in the device, their properties, and potential biological risks must be provided.

Additionally, manufacturers should include any existing relevant data and identify any gaps based on a risk analysis. Transitioning to electronic submissions has streamlined the evaluation process significantly.

International Collaboration

ANVISA actively collaborates with international regulatory bodies to ensure alignment with global standards. This collaboration includes adherence to ISO 10993, enhancing global compliance. Consequently, this facilitates smoother market access for Brazilian manufacturers and promotes international competitiveness.


In conclusion, the biological evaluation for medical devices in Brazil is a rigorous and essential process. It ensures compliance with both national and international standards, particularly ISO 10993. This process ultimately safeguards public health and promotes global market access, ensuring that medical devices meet the highest safety and performance requirements.

Why do you need this service?

Compliance with Regulations: Manufacturers need the biological evaluation service to ensure compliance with international standards and regulations (e.g. ISO 10993-1).

The service aids in evaluating and managing potential risks associated with the device. It assesses factors such as toxicity, irritation, sensitization, and other potential biological responses that could harm users.

Our biological evaluations can provide crucial data during the product development stage, helping manufacturers make informed decisions about materials and designs to ensure safety, effectiveness, and this saves resources.

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