July 10, 2025, has become a watershed moment for Brazil’s medical device market regulation—the Unique Device Identification (UDI) compliance requirements by the Brazilian Health Regulatory Agency (ANVISA) for high-risk Class IV medical devices are now officially in effect. This means that Class IV devices manufactured after this date must bear a UDI label to enter the Brazilian market. For all Chinese medical device manufacturers exporting to Brazil: the compliance grace period is now closed. The implementation of Brazil’s UDI system has entered a substantive phase, and companies must act immediately to prevent their products from being held up at Brazilian customs.
I. Timeline for Brazil’s UDI Regulation Implementation
According to ANVISA’s Resolution RDC 591/2021, Brazil’s UDI implementation for medical devices adopts a phased strategy, progressing from high-risk to low-risk categories.
Deadlines for General Medical Devices (based on manufacturing date):
- Class IV devices: Effective from July 10, 2025 (Now Active)
- Class III devices: Effective from January 10, 2026
- Class II devices: Effective from January 10, 2027
- Class I devices: Effective from January 10, 2028
Reusable devices (requiring UDI to be directly marked on the device itself) benefit from an extended timeline:
- Class IV devices: Effective from July 10, 2027
- Class III devices: Effective from January 10, 2028
- Class II devices: Effective from January 10, 2029
- Class I devices: Effective from January 10, 2030
It is particularly important to note that certain specific categories, such as coronary stents, drug-eluting coronary stents, and hip/knee replacement implants, were subject to UDI requirements much earlier, starting from June 20, 2020.
II. Composition of UDI Codes and Labeling Requirements
The UDI is known as the “digital ID card” for medical devices, consisting of two parts:
- UDI-DI (Device Identifier): An alphanumeric code that uniquely identifies a specific device model, serving as the “key” to access the UDI database.
- UDI-PI (Production Identifier): Identifies production information for a single unit, which may include serial number, lot number, manufacturing date, expiration date, or software version.
ANVISA has clear requirements for label format:
- Must include both a machine-readable code (AIDC) and human-readable text (HRI).
- AIDC technologies can include 1D barcodes, 2D codes (e.g., QR codes), RFID, etc., with no specific technology mandated. HRI text must clearly display the UDI-DI and UDI-PI content, with no mandatory line breaks required.
Rules for Using the UDI Symbol:
- If the label contains only one type of AIDC code, the UDI symbol is not required.
- If the label contains multiple AIDC codes (e.g., both a barcode and a QR code), the UDI symbol must be present to indicate their location.
Exemptions:
- Transport containers (e.g., shipping containers) do not require a UDI label, but the product’s own label and packaging must comply with the requirements.
III. Progress on Brazil’s UDI Database (SIUD)
ANVISA has established the national UDI database—the SIUD system—and publicly demonstrated it on June 30, 2025.
Currently, the official operation of the SIUD system awaits the publication of the Implementing Norm (IN) regulation (originating from Public Consultation CP 1313/2025), expected no earlier than September 2025. The mandatory timeline for companies to submit UDI data to SIUD will commence after the IN comes into effect and is calculated separately from the labeling implementation dates.
This means companies currently have two independent but related tasks: immediate compliance with labeling requirements and preparation for future data submission.
In the future, government agencies will be able to query SIUD data in real-time via APIs or mobile apps, enabling full supply chain traceability.
IV. Urgent Action Checklist for Companies
Facing the now-active UDI requirements for Class IV devices, exporting companies need to take the following actions immediately:
- Immediately Audit Products and Production Plans:
- Review the list of Class IV medical device products exported to Brazil. Identify which products require UDI labeling per the new regulations in the near term.
- Generate Compliant UDI Codes:
- Contact issuing agencies like GS1 to ensure the codes comply with the International Medical Device Regulators Forum (IMDRF) standards.
- Update Label Templates:
- Integrate the AIDC code and HRI text. Add the UDI symbol as required by the rules (if applicable).
- Prepare SIUD Data:
- Proactively organize the device information required for submission (refer to Annex 1 of RDC 591) for upload as soon as the system opens.
- Verify Inventory Handling:
- Inventory of Class IV devices produced before July 10, 2025, can still be sold and does not require urgent rework. However, devices manufactured on or after July 10, 2025, must comply with the new regulations.
Furthermore, companies need to collaborate closely with supply chain partners. UDI labeling involves multiple stages such as label printing and raw material procurement. Ensure all suppliers can meet the UDI printing requirements.
V. Impact of the New Regulations and Response Strategies
The implementation of Brazil’s UDI regulations presents both challenges and opportunities for companies. Major challenges include:
- Production Process Adjustments: Companies need to modify existing production processes to integrate the UDI labeling step. This may involve equipment procurement/upgrades, personnel training, and process optimization.
- Label Design Re-planning: Label and packaging designs must be re-laid out to ensure UDI codes meet ANVISA’s requirements for size, clarity, placement, etc.
To address these challenges, companies can seek help from professional medical device CRO companies (such as Glo-Region CRO) or regulatory consulting agencies to enhance compliance capabilities. The key to successfully navigating the new regulations lies in advanced planning and comprehensive preparation. Companies should establish a cross-functional task force, including teams from regulatory affairs, quality, production, and logistics, to ensure smooth UDI implementation.
For companies exporting medical devices to Brazil, time is extremely pressing. The UDI labeling mandate for Class IV devices is now officially effective, and the compliance deadline for Class III devices is also imminent—January 10, 2026.
Brazilian customs have begun verifying UDI compliance. Medical devices without this “electronic ID card” risk customs clearance delays and market access denial. Immediate action is necessary to ensure uninterrupted access to the Brazilian market.
If you require professional support and services during this process, please feel free to contact us at any time.