March 21, 2025
ANVISA Introduces New Regulatory Framework for Medical Device Identification
The Brazilian Health Regulatory Agency (ANVISA) has launched Public Consultation No. 1,313 on March 18, 2025, proposing a new Normative Instruction that establishes requirements for the transmission and management of the Unique Device Identification (UDI) database for medical devices in Brazil.
This initiative is part of ANVISA’s 2024-2025 Regulatory Agenda (Theme No. 11.12) and aims to implement the provisions outlined in Article 15, Paragraph 3 of Resolution of the Collegiate Board of Directors (RDC) No. 591, of December 21, 2021.
Key Implications for Medical Device Manufacturers and Importers
The proposed Normative Instruction represents a significant advancement in medical device regulation in Brazil, aligning the country’s regulatory framework with international standards for unique device identification systems. For medical device companies operating in Brazil, this development brings both opportunities and responsibilities:
- Enhanced Traceability: The UDI system will enable better tracking of medical devices throughout their lifecycle, from production to patient use.
- Improved Safety Monitoring: Regulatory authorities will be able to more effectively monitor and respond to safety issues, potentially reducing the time to identify and resolve problems.
- Streamlined Recall Process: In case of necessary recalls, the UDI system will facilitate more efficient and targeted actions.
- Market Access Considerations: Companies must ensure compliance with these new requirements to maintain and expand their access to the Brazilian healthcare market.
Compliance Preparation Steps
Medical device manufacturers and importers should begin preparing for these upcoming requirements by:
- Reviewing current product labeling and data management systems
- Assessing their readiness to generate and transmit UDI data according to ANVISA’s specifications
- Considering potential investments in technology infrastructure to support UDI compliance
- Engaging with regulatory consultants experienced in Brazilian medical device regulations
Industry Impact
This regulatory development comes at a time when the global medical device industry is increasingly focusing on standardized identification systems. For executives in medical device companies, particularly those from North America and Europe looking to enter or expand in the Brazilian market, understanding and complying with these UDI requirements will be crucial for successful market access strategies.
The public consultation period provides an important opportunity for stakeholders to contribute to the final version of this Normative Instruction. Industry participants are encouraged to review the proposal and submit comments to help shape a regulatory framework that balances safety requirements with practical implementation considerations.
Access the Normative Instruction
For stakeholders interested in reviewing the complete proposal and participating in the public consultation process:
Access the Official Public Consultation on ANVISA’s Website
Download the English Translation of the Proposed Normative Instruction
About ANVISA
The Brazilian Health Regulatory Agency (ANVISA) is responsible for approving and supervising food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. Headquartered in Brasília, ANVISA plays a central role in ensuring that medical devices marketed in Brazil meet appropriate standards for safety and efficacy.
For medical device companies navigating the complex regulatory landscape in Brazil, maintaining awareness of these evolving requirements is essential for successful market entry and ongoing compliance.
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