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ANVISA Releases Preliminary Guidance on Brazil's UDI Database

🔔 ANVISA Releases Preliminary Guidance on Brazil's UDI Database

The Brazilian Health Regulatory Agency (ANVISA) has published a preliminary manual outlining the structure and operation of its Unique Device Identification (UDI) database, also referred to as SIUD.

📌 This database aims to improve the traceability, identification, and monitoring of medical devices in Brazil.

Key highlights:
🆔 The system will store Basic UDI-DI, UDI-DI, and related device information.
🔄 It will support integration with the National Health Surveillance System (SNVS).
📅 Manufacturers and importers will be required to submit data according to implementation timelines.
💡 The guide is still under consultation and open to stakeholder feedback. Final rules will be defined in future regulatory documents.

🔗 Read the full ANVISA announcement https://lnkd.in/duRrE3HB

Follow MedRAIS for more regulatory updates! 📌

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