巴西ANVISA RDC 591/2021：醫療器械唯一識別（UDI）系統

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.

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。

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.

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。

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。

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.