{"id":8300,"date":"2025-05-30T12:47:38","date_gmt":"2025-05-30T04:47:38","guid":{"rendered":"https:\/\/regask.com\/?p=8300"},"modified":"2025-05-30T12:47:38","modified_gmt":"2025-05-30T04:47:38","slug":"vorlaufiges-handbuch-zur-anvisa-udi-datenbank-rdc591","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/anvisa-udi-database-preliminary-manual-rdc591\/","title":{"rendered":"ANVISA ver\u00f6ffentlicht vorl\u00e4ufiges Handbuch f\u00fcr Brasiliens UDI \u2026"},"content":{"rendered":"

ANVISA Publishes Preliminary Manual for Brazil\u2019s Unique Device Identification (UDI) Database<\/strong><\/p>\n

May 28, 2025<\/em> \u2013 The Brazilian National Health Surveillance Agency (ANVISA) has released a preliminary manual detailing the operation of its Unique Device Identification (UDI) database<\/strong>. This step brings Brazil closer to international standards for medical device traceability, aligning with the International Medical Device Regulators Forum (IMDRF) and the country\u2019s Resolution RDC 591\/2021<\/strong>.<\/p>\n

The manual outlines the current functionalities of the UDI database, with additional features still in development. The recent Public Consultation CP 1313\/2025<\/strong>, which gathered input from stakeholders, closed on May 26, 2025<\/strong>. The UDI system will become fully operational once the related Normative Instruction (IN)<\/strong> is finalized and enacted.<\/p>\n

Key Takeaways:<\/h3>\n
    \n
  • \n

    Purpose of the UDI System:<\/strong> Improve patient safety and enhance regulatory oversight by standardizing medical device identification across Brazil.<\/p>\n<\/li>\n

  • \n

    RDC 591\/2021:<\/strong> Establishes a national UDI database for all registered medical devices.<\/p>\n<\/li>\n

  • \n

    Compliance Deadlines<\/strong> (from the IN\u2019s effective date):<\/p>\n

      \n
    • \n

      Class IV devices: 3.5 years<\/p>\n<\/li>\n

    • \n

      Class III devices: 4 years<\/p>\n<\/li>\n

    • \n

      Class II devices: 5 years<\/p>\n<\/li>\n

    • \n

      Class I devices: 6 years<\/p>\n<\/li>\n<\/ul>\n<\/li>\n

    • \n

      Manual Scope:<\/strong> Provides operational guidance for completed features; pending features will be addressed in future updates.<\/p>\n<\/li>\n<\/ul>\n

      ANVISA is currently reviewing feedback from the public consultation and will proceed to finalize the Normative Instruction. The final version of the UDI manual will be published alongside or shortly after the IN takes effect.<\/p>\n

      Please ask RegASK to monitor all developments closely and start preparing internally to meet upcoming compliance deadlines once the IN is in force.<\/strong><\/p>\n

      \n
      \n
      \n
      \n
      \n

      \n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      ANVISA ver\u00f6ffentlicht vorl\u00e4ufiges Handbuch f\u00fcr Brasiliens Datenbank zur eindeutigen Produktidentifizierung (UDI) \u2013 28. Mai 2025 \u2013 Die brasilianische Gesundheitsbeh\u00f6rde ANVISA hat ein vorl\u00e4ufiges Handbuch zur Funktionsweise ihrer Datenbank zur eindeutigen Produktidentifizierung (UDI) ver\u00f6ffentlicht. Dieser Schritt bringt Brasilien den internationalen Standards f\u00fcr die R\u00fcckverfolgbarkeit von Medizinprodukten n\u00e4her und orientiert sich an der Internationalen Richtlinie f\u00fcr Medizinprodukte\u2026<\/p>","protected":false},"author":43,"featured_media":8319,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[512,39],"tags":[630,631],"class_list":["post-8300","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-brazil-regulations","category-medical-devices-insights","tag-unique-device-identifiers-udi","tag-international-medical-device-regulators-forum-imdrf"],"acf":[],"yoast_head":"\nANVISA Preliminary Manual for Brazil\u2019s UDI Database<\/title>\n<meta name=\"description\" content=\"ANVISA has published a preliminary manual for Brazil\u2019s Unique Device Identification (UDI) database under RDC 591\/2021. 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