Understanding the Regulatory Impact of Brazil's Ofício Circular Nº 2/2025 on UDI Implementation

Area	Key change	Impact on foreign manufacturers/importers
Regulatory deadlines	• Mandatory UDI on labels of risk‑class IV devices placed on the Brazilian market from 10 July 2025; class III 10 Jan 2026, class II 10 Jan 2027, class I 10 Jan 2028. • For re‑usable devices the same sequence applies + 2 years. (Serviços e Informações do Brasil)	• Class IV products shipped after 10 July 2025 without UDI will be non‑compliant and may be refused customs clearance or recalled. • Manufacturers still using global trade‑item numbers (GTIN) alone must migrate quickly.
Label & packaging requirements	UDI (UDI‑DI + UDI‑PI) must appear in both AIDC (e.g., 2‑D DataMatrix) and HRI (human‑readable)‑if‑only‑one‑AIDC‑symbol; all packaging levels except transport containers. (Serviços e Informações do Brasil)	• Artwork changes, barcode quality validation and re‑qualification of packaging lines are required. • Master label approvals submitted to Anvisa need updating in e‑IF documentation bundles.
UDI database (SIUD)	Anvisa’s national database SIUD finished internal build May 2025; public release will follow an **Instruction Normative (IN) now under review (CP 1.313/2025); entry into force not expected before Sept 2025. (Serviços e Informações do Brasil)	• Once the IN is in force, manufacturers will have time‑bound obligations to upload UDI data, via web portal or machine‑to‑machine API. • Early integration work will avoid a bottleneck when the window opens.
Market surveillance & recalls	Brazilian authorities will obtain real‑time verification capability once SIUD is populated (full coverage expected by 2031). (Serviços e Informações do Brasil)	• Expect faster targeted field actions; incomplete UDI records may delay import licensing (LI) issuance or trigger import holds.
Transition support	Three pilot tests with industry already run; a final pilot (API focus) is planned before IN publication. (Serviços e Informações do Brasil)	• Companies that volunteer gain early access to technical specs and can shape API guidance.

Actionable Insights & Checklist

Priority (◆ = high)	Recommended action	Benefits
◆ Gap‑assessment sprint (now – Aug 2025)	Map all class IV SKUs shipping to Brazil; confirm whether current labels contain both AIDC & HRI elements and that UDI‑DIs are assigned per IMDRF rules.	Avoid shipment blocks from 10 July 2025.
◆ Artwork & packaging line change‑control	Launch change orders for label redesign, barcode grading (≥ C/1.5) and packaging hierarchy mapping; validate in Portuguese label samples.	Ensures readability throughout Brazilian cold‑chain humidity ranges.
◆ Master data readiness for SIUD	Build a UDI data‑set (≈ 50 data elements) aligned with Annex I in a structured repository; designate a data‑steward.	Enables “one‑click” upload when the IN takes effect; supports post‑market vigilance.
◆ ERP / PLM integration roadmap	Develop interface specs for SIUD APIs (JSON/REST anticipated); budget IT resources for Q4 2025.	Automation prevents manual key‑in errors and supports post‑market traceability KPIs.
◆ Importer & distributor contracts	Add clauses assigning responsibilities for: 1) UDI label verification at receiving, 2) timely upload to SIUD, 3) field safety corrective actions (FSCA) traceability.	Shared liability is clearer; reduces supply‑chain friction.
◆ Customs & ANVISA channel dry‑run	Before 10 July, send pilot shipments with full UDI barcode and ask broker to simulate LI clearance.	Surfaces scanner compatibility or Siscomex filing issues early.
◆ Training & communication	Prepare bilingual (EN/PT‑BR) SOP addendum + e‑learning for regulatory, logistics, and service teams; highlight class‑based timelines.	Harmonises understanding across HQ and Brazilian affiliates.
■ Engage in final SIUD pilot	Register interest with GGTPS; test machine‑to‑machine submissions.	Early influence and troubleshooting.
■ Monitor regulatory calendar	Track publication of the IN and its grace periods; subscribe to Anvisa RSS or set internal alert.	Ensures no missed compliance milestones.

Strategic Outlook (12–24 months)

1. Competitive differentiation – Early movers can advertise enhanced traceability, helping hospital procurement and supporting value‑based purchasing initiatives in Brazil’s SUS and private networks.

2. Digital service add‑ons – UDI data fuels patient apps, asset‑tracking and predictive maintenance; consider bundling these to stand out.

3. Harmonisation leverage – Brazil’s framework mirrors EU MDR & US FDA UDI; synergies let global manufacturers reuse data and processes, lowering marginal compliance cost.

4. Risk of fragmentation – Delayed SIUD uploads may force manual record‑keeping by distributors, inflating administrative cost and error risk.

Immediate Next Steps (before 10 July 2025)

1. Confirm every shipment‐ready class IV device carries compliant UDI on label and all higher‑level packaging.

2. Issue a regulatory notification to Brazilian AO – outline your phased UDI compliance plan and request feedback.

3. Schedule internal audit week of 28 July to verify implementation in manufacturing and documentation systems.

Timely alignment with Ofício Circular Nº 2/2025/GGTPS keeps your products flowing, minimises detention risk, and positions your organisation for the digital traceability future Brazil is building.