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January 15, 2026
Approximately 5 minutes
RDC No. 591/2021, effective January 10, 2022, establishes the Unique Device Identification (UDI) system for medical devices regulated by ANVISA in Brazil. The system enables unambiguous identification of devices throughout distribution and use. It applies to all regularized medical devices, including IVDs, except custom-made devices and those under clinical investigation. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Manufacturers must assign UDI to devices and all packaging levels (except shipping containers) before market placement, using accredited issuing entities. Quality systems must ensure correct UDI assignment. Holders (importers/local responsible) verify compliance and ensure data consistency in the UDI database. For high-risk implants (e.g., coronary stents, hip/knee), UDI must appear on traceability tags. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
UDI comprises UDI-DI (unique per model) and UDI-PI (production controls like serial, batch, expiry, SaMD version). Applied via AIDC and HRI on labels and packaging. Special cases: reusable devices need permanent UDI; single-use low-risk may have UDI on higher packaging. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
UDI carrier (AIDC + HRI) must be on device label or packaging, legible throughout lifetime. Exceptions for space constraints, single-use devices, lay-use products (HRI prioritized). RFID requires accompanying barcode. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Holders submit core data (per Annex I: quantity, UDI-DI, production controls, manufacturer details, GMDN code, etc.) to ANVISA's public UDI database before marketing. Updates required for changes. Data freely accessible to public. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Phased implementation from effective date:
Reusable devices: additional 2 years for direct marking. Pre-deadline manufactured devices optional compliance. Database submission starts upon ANVISA publication. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Exempt: shipping containers, certain single-use disposables in kits, orthopedic trays configured per order. In-house low-risk SaMD exempt under separate rules. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
UDI required in adverse event/technical complaint/field action reports. Non-compliance constitutes health infraction; possible suspension of sale/import/use. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
Align with IMDRF principles; select accredited issuer early. Document UDI assignment in QMS. Plan phased compliance by class. Ensure holder-manufacturer coordination for database accuracy. Monitor updates on database launch. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
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ElendiLabs
Yes. The Brazilian UDI framework not only requires placing the UDI on device labels and packaging, but also requires manufacturers to submit the corresponding device identification information to ANVISA’s UDI database. This database supports traceability, post-market surveillance, and recall management.
Anonymous
如果我們的產品是一套手術器械套件（例如骨科手術包），UDI是為整個套件分配一個代碼，還是每個單獨器械都需要自己的UDI？
ElendiLabs
一般來說，UDI會分配給每一個“device model”或包裝層級。如果手術套件作為一個整體產品銷售，通常會為整個套件分配一個UDI。但如果套件中的器械單獨銷售或具有獨立型號，則可能需要各自的UDI。具體情況需依照產品的市場供應方式與ANVISA的規定判斷。
Anonymous
We distribute imported infusion pumps in Brazil. If the original manufacturer already uses a GS1 barcode for UDI in Europe, can the same UDI be used for the Brazilian market?
ElendiLabs
In many cases, manufacturers can use the same UDI issued by an accredited agency (such as GS1) across multiple markets, including Brazil. However, the device information must still be submitted to Brazil’s national UDI database managed by ANVISA. Companies should verify that the data format and submission requirements align with Brazilian regulations.
Anonymous
我們公司準備在巴西銷售心臟監測設備。UDI是否只需要放在外包裝上，還是設備本體與包裝都需要標示？
ElendiLabs
根據UDI制度的基本原則，UDI通常需要標示在器械標籤與包裝上，以確保可追溯性。在某些情況下，若設備設計允許，UDI也可能需要直接標示在設備本體（Direct Marking）。具體要求會取決於器械類型與ANVISA相關規定。
Anonymous
我们是一家中国制造商，正在准备向巴西出口一次性导尿管。听说巴西正在实施UDI系统，请问是否所有医疗器械都必须有UDI代码？
ElendiLabs
巴西的UDI系统由ANVISA逐步实施，并不是所有产品在同一时间点都必须立即符合。通常会根据医疗器械的风险等级分阶段执行。高风险器械通常需要更早符合UDI要求，而低风险器械可能有更长的过渡期。制造商应密切关注ANVISA发布的实施时间表，并提前准备UDI编码。
Anonymous
Our company manufactures Class II dental implants and plans to register them in Brazil. Do we need to apply for a UDI before submitting the registration to ANVISA, or can the UDI be assigned after approval?
ElendiLabs
In Brazil, the Unique Device Identification (UDI) system is being implemented by ANVISA to improve device traceability. Manufacturers are generally expected to assign a UDI from an accredited issuing agency (such as GS1) and submit the device identification information to the national database when required. The exact timing may depend on the device risk class and implementation timeline, but planning the UDI assignment before or during registration preparation is recommended.
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Anonymous
Our startup is developing a wearable ECG monitoring patch intended for Brazil. Besides placing the UDI on the label, do we also need to submit device data to a Brazilian UDI database?