UDI beyond US & EU: Navigating UDI Mandates in LATAM and APAC

For the last five years, the medical device industry has suffered from “tunnel vision,” fixated almost entirely on the US FDA’s GUDID and the European Union’s EUDAMED. While these two giants consumed the majority of regulatory budgets and attention, a quiet storm has been brewing in the Southern Hemisphere and the Asia-Pacific region.

We are now in January 2026. The global regulatory landscape has shifted. Compliance is no longer a binary choice between “US” and “EU.” It is a fragmented mosaic of regional mandates, each with its own deadlines, data attributes, and labeling idiosyncrasies.

As we look at the 12 to 24-month horizon, the pressure points are moving. If you are a manufacturer distributing globally, your next biggest risks are not in Brussels or Washington D.C., but in Brasília, Bogotá, Beijing, and Canberra.

This is your roadmap to navigating the emerging UDI mandates in LATAM and APAC for 2026 and beyond.

The LATAM Frontier: Immediate Action Required

Latin America has moved from “planning” to “enforcement” rapidly. The two largest economies, Brazil and Colombia, have deadlines that are either active right now or imminent.

Brazil (ANVISA): The Post-Deadline Reality

If you market Class III medical devices in Brazil, you have just crossed a critical threshold. The deadline for Class III compliance under RDC 591/2021 (and subsequent amendments) was January 10, 2026.

Status Check:

• Class III: If your data was not submitted to the ANVISA database (SIUD) by last week, you are technically non-compliant. Immediate remediation is required to avoid customs stoppages.
• Class II (The Next Wave): The clock is now ticking for Class II devices, with a deadline of January 10, 2027. You have exactly 12 months. Do not underestimate this. Class II portfolios are typically much larger than Class III, meaning the volume of data you need to cleanse and attribute is significantly higher.
• Class I: Compliance is set for January 10, 2028.

The Brazilian Challenge: unlike the FDA, ANVISA’s UDI system often requires a “dynamic” approach where the UDI data submission is linked closely with the registration renewal cycles.

Colombia (INVIMA): The February Crunch

While Brazil focuses on risk classes, Colombia is aggressively closing the gap. Manufacturers with Class IIa devices and Class I devices registered before 2024 face a hard deadline on February 9, 2026.

That is less than a month away.

What is required? You must update your registration with the UDI-DI (Device Identifier) information. INVIMA uses a reporting structure that can be administratively heavy. If you have treated Colombia as a “secondary” market, verify your local Authorized Representative (AR) has the data they need. Missing this February window could lead to the suspension of your commercialization rights.

The APAC Surge: Complexity and Volume

The Asia-Pacific region presents a different challenge: data divergence. While LATAM largely follows US/EU conventions (using GS1 standards), APAC regulators often add local flavors that break standard global templates.

Australia (TGA): The July 2026 “Big Bang”

Australia is arguably the most critical deadline on the global calendar for 2026. The Therapeutic Goods Administration (TGA) has set July 1, 2026, as the mandatory compliance date for Class III and Implantable Class IIb devices.

Why this is different: Australia is not just asking for data; they are asking for connections. The AusUDID database (Sandpit and Production) requires a validated connection.

• Labeling: By July 1, physical labels must bear the UDI carrier.
• Data: The UDI data must be present in the AusUDID.
• GMDN Code: Australia relies heavily on GMDN. If your global data set uses EMDN (for Europe) or FDA Product Codes (for US), you must ensure your GMDN mapping is precise.

China (NMPA): The Long March Continues

China has successfully implemented UDI for Class III and high-risk Class II devices. The focus now shifts to the massive volume of the remaining Class II devices (including many IVD reagents), with a deadline set for June 1, 2027.

The “Chinese Wall” of Data: China remains the most difficult UDI region for foreign manufacturers because:

1. Code Ownership: You must often utilize a Chinese agency or partner to handle the NMPA database submissions.
2. Dataset Unique Fields: NMPA requires specific attributes (like the “NMPA Code” or specific Chinese category codes) that do not exist in GUDID or EUDAMED.
3. Local Agent Reliance: Your local Chinese agent controls the submission. If you change agents, you risk losing control of your UDI data history.

South Korea & Emerging Markets

• South Korea (MFDS): While the core UDI implementation is complete (Class I finished in 2022), the new frontier is Digital Health. The Digital Medical Products Act, effective recently, introduces new tracking requirements for Software as a Medical Device (SaMD). If you sell digital health products, standard UDI rules may now have an additional layer of complexity.
• Singapore, Taiwan, & Saudi Arabia: These markets are generally aligned with the IMDRF guidelines but watch for “Phase 3” expansions into lower-risk classes throughout 2026 and 2027.

The Strategic Trap: “Copy-Paste” Compliance

The biggest mistake Regulatory Affairs teams make is assuming that if they are compliant in the US and EU, they are “90% ready” for LATAM and APAC.

This is false. In reality, you are likely only 60% ready.

The Delta (The 40% Gap):

• Local Validations: Brazil requires specific registration numbers to be linked to the UDI. China requires NMPA registration numbers. These are dynamic fields that change with every certificate renewal.
• Character Limits & Language: Developing a “Global Label” is becoming impossible. Australia requires specific sponsor details. Brazil requires Portuguese. China requires Simplified Chinese. The physical real estate on your packaging is shrinking.
• Trigger Events: In the EU, a UDI update is triggered by a “significant change.” In some APAC regions, a simple distributor change might trigger a UDI update requirement.

A Roadmap for 2026: Centralization is Survival

To survive this fragmented landscape without hiring a dedicated army of regulatory associates, you must pivot from “regional execution” to “global centralization.”

1. Establish a “Golden Record” Stop managing UDI data in regional silos (e.g., “The Brazil Spreadsheet” vs. “The China Spreadsheet”). You need a single Master Data Management (MDM) system that holds the “Super Set” of all global data attributes—FDA, EUDAMED, NMPA, TGA, and ANVISA combined.

2. Automate the “Delta” Your system should automatically flag when a change in one region affects another. If you update the “Sterilization Method” for EUDAMED, your system should tell you if that data point needs to be pushed to the Australian AusUDID or if it triggers a modification in China.

3. Prioritize by Revenue Risk With the Australia (July 2026) and Brazil (Jan 2027) deadlines looming, map your portfolio revenue against these deadlines. A Class II device that generates high revenue in Brazil needs to be prioritized for data cleaning now, not in Q4.

Conclusion

The era of global UDI harmonization is, ironically, leading to operational fragmentation. While the concept of UDI is global, the execution is intensely local. The manufacturers who succeed in 2026 will be those who stop treating these mandates as isolated hurdles and start building a globally integrated data engine.

The deadlines in Brazil, Colombia, and Australia are real. The time to prepare is now. Explore the Global UDI Compliance Solution by DDi.