In an effort to improve patient safety and streamline regulatory processes, the Brazilian Health Regulatory Agency, ANVISA, has introduced new rules for medical device manufacturers. Starting on March 1, 2026, the ANVISA Normative Instruction No. 426 will require manufacturers to comply with the Unique Medical Device Identification (UDI) system. This regulation impacts all medical devices sold and distributed in Brazil, marking a significant shift in how devices are tracked and managed throughout their lifecycle. But what does this mean for medical device manufacturers? In this post, we break down the key changes and how manufacturers can prepare for the new requirements.
WHAT IS UDI AND WHY DOES IT MATTER?
At its core, the UDI requirements provide each medical device with a unique identifier. This identifier makes it easier to track and trace devices as they move through the supply chain, from manufacturing to patient use. It plays a crucial role in improving the safety, regulatory compliance, and traceability of medical devices. Previously introduced by the FDA in the U.S., the UDI system is now being implemented by Brazil through ANVISA. This initiative aims to enhance patient safety by ensuring that every medical device on the market can be identified and monitored. Whether it’s for recalling faulty products or verifying their authenticity, UDI makes tracking devices more efficient and transparent.
KEY REQUIREMENTS UNDER NORMATIVE INSTRUCTION NO. 426
1. Mandatory UDI Data Submission
Starting March 2026, all medical devices that fall under ANVISA Collegiate Board Resolution No. 591/2021 must have their UDI data transmitted to the SIUD system before being sold in Brazil. This submission must occur before the device is marketed and must align with the device data approved by ANVISA. The company holding the device’s sanitary registration is responsible for ensuring that the UDI requirements data matches the approved details.
2. Methods of Data Transmission
There are two methods for submitting UDI data: Individualized Submission: Each device model’s UDI data is submitted one by one through a user-friendly interface on the SIUD portal. Bulk Submission: For companies managing multiple products, UDI data can be submitted for several device models at once by uploading a structured file. This can be done manually or through machine-to-machine communication, providing an efficient way for large manufacturers to manage UDI data.
3. Ensuring Data Accuracy
The UDI data transmitted must correspond precisely with the information already approved by ANVISA. While only the UDI-DI (Device Identifier) needs to be transmitted, manufacturers must also maintain the UDI-PI (Production Identifier) within their Quality Systems for traceability. This ensures that every device can be traced from production through distribution and use.
4. Corrections and Updates to UDI Data
If errors are found in the submitted UDI data, manufacturers have a 60-day grace period to make corrections. After this, only data that does not require a new UDI-DI can be modified. This process encourages accuracy at the outset and reduces the need for corrections later.
5. Ownership Transfers and UDI Updates
If a device’s ownership is transferred, the new manufacturer must update the UDI data within 30 days of the ownership transfer being finalized. This ensures that the correct entity is responsible for the device’s traceability in the SIUD system.
6. Device Discontinuation
When a medical device is no longer available in the market, or its sanitary registration is canceled, the manufacturer must notify ANVISA within 30 days. This action ensures that the UDI data for discontinued devices is deactivated and removed from the system, keeping the UDI database current and accurate.
HOW THIS IMPACTS MEDICAL DEVICE MANUFACTURERS
1. Compliance Preparation
Manufacturers must act quickly to ensure compliance with the new UDI regulations. This includes reviewing their product portfolios, confirming their devices are correctly registered with ANVISA, and ensuring that all relevant UDI data is accurately prepared for submission. Companies should also set up systems to maintain UDI-PI components for full traceability, in line with regulatory requirements.
2. Streamlining Inventory and Supply Chain Management
The UDI regulations can help manufacturers streamline their supply chain and inventory management. With unique identifiers for each product, devices will be easier to trace from the manufacturer to the healthcare provider. Manufacturers will need to update their labeling and packaging to include the UDI code, and ensure that their internal systems are capable of integrating this data for better management.
3. Maintaining Market Access
For manufacturers selling in Brazil, failure to comply with the new UDI requirements could prevent continued market access. Once the mandatory UDI transmission deadlines are reached, devices that haven’t been registered in SIUD may be pulled from the market. To avoid disruptions, manufacturers should begin preparing now to ensure their devices are fully compliant before the deadlines.
4. Third-Party User Registrations
Manufacturers can register third-party users to submit UDI data on their behalf. This can be helpful for large companies or those managing numerous devices. However, the manufacturer remains responsible for ensuring that third-party submissions are accurate and follow the required processes. Companies should carefully manage their third-party relationships to avoid errors in UDI submissions.
WHAT MANUFACTURERS CAN DO NOW
The good news is that manufacturers don’t need to wait until March 2026 to begin preparing for UDI regulations. The more proactive they are now, the easier it will be to comply with the UDI requirements for medical devices. Here’s what manufacturers can do to get ahead of the curve:
1. Review Product Portfolios: Ensure that all devices requiring UDI are registered with ANVISA, and all UDI data is available and accurate, in line with UDI regulations.
2. Upgrade UDI Management Systems: Manufacturers should upgrade their quality management and traceability systems to handle UDI data, meeting the necessary UDI requirements for medical devices.
3. Monitor ANVISA Updates: Stay informed about any new guidelines or changes to the UDI implementation process by regularly checking ANVISA’s website to stay aligned with the evolving UDI regulations.
4. Train Employees and Third-Party Users: It’s important to educate both internal teams and any third-party users involved in UDI submissions. Everyone must understand the UDI requirements for medical devices to ensure compliance.
CONCLUSION
ANVISA’s Normative Instruction No. 426 is a game-changer for medical device manufacturers in Brazil. While it introduces additional compliance requirements, it also provides significant benefits, such as improved device traceability, enhanced patient safety, and better regulatory oversight. By taking action now to prepare for these changes, manufacturers can ensure smoother market access, better supply chain management, and ultimately, stronger relationships with regulators and patients alike.
HOW MORULAA CAN HELP
At Morulaa, we provide expert support for medical device manufacturers navigating ANVISA’s new UDI requirements regulations. We help ensure compliance with the mandatory UDI-DI data submission to the SIUD system, guiding you through both individualized and bulk submission processes. As your Authorized Indian Agent, we also ensure your device meets all regulatory requirements for market entry, supporting efficient registration with CDSCO and Maximize approvals from trusted global authorities like the FDA and CE for faster market access. Beyond initial regulatory approval, we assist with post-market compliance, ensuring continued compliance to safety and performance standards. With Morulaa, you can confidently manage UDI compliance and expand into new markets smoothly.