Anvisa Opens Public Consultation on UDI: Understand the New Requirements for Medical Devices
The Brazilian Health Regulatory Agency (Anvisa) has announced the opening of a public consultation to gather contributions regarding the requirements for the transmission and management of the Brazilian Unique Device Identification (UDI) database for medical devices. The initiative aims to enhance regulation and ensure the safety and traceability of medical devices marketed in Brazil.
The regulation under consultation specifically addresses the proposed normative instruction that defines the basic conditions for submitting UDI data to Anvisa. According to the Agency, the database, named the Unique Device Identification System (SIUD – Sistema Único de Identificação de Dispositivos), is already ready to receive information from companies in the sector.
It is crucial to highlight that data submission to SIUD will not be mandatory immediately upon the new normative instruction coming into effect. The deadlines for mandatory transmission comply with the Collegiate Board Resolution (RDC) No. 591/2021 and will be counted from the effective date of the new regulation.
The public consultation will remain open for a 60-day period, from March 27 to May 26, 2025. During this time, all interested parties, including medical device companies, healthcare professionals, and other stakeholders, can submit their contributions to help shape the regulation.
The implementation of SIUD represents a significant advancement for the safety and traceability of medical devices in the country, enabling more effective control over the circulation of these products in the market. With active public participation in the consultation, Anvisa expects to consolidate a robust and efficient system for medical device identification.
UDI is an international standard system aimed at ensuring greater transparency and safety in the medical device sector. With the implementation of this system in Brazil, the traceability of medical devices will be enhanced, allowing for more precise identification of products throughout their entire lifecycle, from manufacturing to final use in patients. Furthermore, SIUD can assist in the detection of non-compliant products, preventing risks to public health.
The adoption of UDI will bring significant benefits to the healthcare sector, including greater efficiency in the management of medical devices by hospitals and clinics, easier traceability of products in case of recalls, and a more effective monitoring system by regulatory bodies.
To participate in the public consultation, interested parties should access the Anvisa website and submit their contributions within the stipulated deadline. This is a unique opportunity for the sector to collaborate directly in defining the guidelines that will govern the management and transmission of UDI data in Brazil. It is essential that manufacturers, importers, distributors, and other interested parties participate actively, ensuring the regulation is aligned with the needs of the market and patient safety.
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