SIUD: Anvisa Launches National System for Unique Identification of Medical Devices

Anvisa has published the SIUD (Unique Identification System for Medical Devices) User Manual, marking the official launch of the Brazilian UDI (Unique Device Identification) system. This tool is a fundamental step in the creation of a national public database with structured and accessible information on medical devices marketed in Brazil.

The measure is provided for in RDC 591/2021 and will be implemented progressively. The system is already available to manufacturers, representatives and distributors operating in Brazil who wish to ensure compliance with national traceability requirements.

What should manufacturers know?

• Current scope:
  SIUD applies exclusively to the UDI-DI (Device Identifier) code. It is not required to submit production data (UDI-PI), such as serial or batch number, date of manufacture or expiry date.

• Submissions by model:
  Each model or presentation of the device must be submitted individually, even when grouped under the same registration or notification number.

• Required fields:
  Fields marked with an asterisk (*) are mandatory and include technical data such as the GMDN code, device characteristics, manufacturer information, among others.

• Reconditioned devices:
  Must have their own UDI and be linked to the UDI of the original new product. The system provides specific fields for this link.

• Publication of data:
  The manufacturer can choose the date on which the submitted data will be made publicly available. If no date is indicated, the data will automatically become public the day after submission.

• Editing data:
  There is a grace period (defined in specific regulations) during which all data can be edited. After this period, only certain fields can be updated. Structural changes require a new submission or evaluation by Anvisa.

• Access by third parties:
  The responsible company may authorize third parties - such as foreign manufacturers or distributors - to submit UDI-DI data on its behalf. However, legal responsibility remains with the registration/notification holder.

Support from Smart MDR

Smart MDR supports manufacturers and legal representatives in the process of adapting to SIUD and RDC 591/2021, offering:

• Training and technical guidance on the system;

• Evaluation and preparation of data for structured submission;

• Compliance strategies in line with good international UDI practices.

If you operate, or intend to operate, in the Brazilian market and need to ensure compliance with Anvisa's new UDI system, get in touch with our team.