Class III in Panic, Class II on Alert: The UDI Lesson Your Company Cannot Ignore

Editorial context - This article presents a scenario set in November 2025. References to “43 days remaining”, relative dates and implementation schedules belong to that historical narrative and are not a statement of current compliance deadlines. The article's original publication date is preserved. Before making regulatory decisions, consult ANVISA's current UDI and SIUD documentation. The original estimates and percentages have been retained as part of the article and have not been independently revalidated for this English edition.

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When medical device companies learn the hard way that regulatory planning is not optional.

Right now, at the end of November 2025, hundreds of Brazilian Class III medical device companies are experiencing something between panic and desperation. Exactly 43 days remain until the final deadline of 10 January 2026, when the UDI (Unique Device Identification) requirement takes effect for this risk class. Many have not even started.

Meeting rooms in turmoil. Desperate calls to code issuing agencies. Emergency negotiations with printers to reprint thousands of labels urgently. Quality teams working in crisis mode, trying to understand in weeks what they should have studied over months. Budgets overrun by emergency costs that could have been 40% lower with proper planning.

This is not speculation. It is happening now. If you work with Class II or Class I medical devices, pay attention. In 14 months (Class II) or 26 months (Class I), your company could be in exactly the same situation unless you learn from the mistakes being made today.

The question defining your operation's future is: will your company repeat the mistake of leaving it until the last minute, or use the time available to implement UDI strategically, minimising costs and maximising benefits?

The Costly Mistake Costing the Sector Millions

Unique Device Identification is nothing new. RDC 591/2021 was published almost four years ago, in December 2021. Its deadlines were clear and phased. In July 2024, RDC 884/2024 granted a further one-year extension to give the market more time.

With so much notice, why are so many companies in a critical situation today?

The answer is simple and worrying: systematic underestimation of regulatory complexity. Many managers saw "January 2026" on the calendar and thought, "I have time." What they failed to calculate was the actual time required for each stage:

1. Selecting an issuing agency: 2 to 3 weeks researching, comparing costs (GS1, HIBCC), analysing future target markets and negotiating contracts.
2. Registration and code generation: 1 to 2 weeks for documentation, approval and receipt of the first UDI-DI codes.
3. Label redesign and approval: 3 to 4 weeks for design, internal reviews, compliance approvals and barcode readability tests.
4. Producing new labels: 2 to 3 weeks allowing for printers' lead times, especially during high demand.
5. Internal system integration: 2 to 4 weeks adapting ERP, WMS and traceability systems.
6. Team training: 1 to 2 weeks training production, stores and dispatch teams in the new processes.

Add these together and you have a minimum of 11 to 18 weeks, or between 2.5 and 4.5 months of effective work. Now consider the year-end holidays, collective shutdowns, 2025 accounting close and 2026 planning between December and January. Available working time shrinks dramatically.

Class III companies that waited until November 2025 are discovering the hard way that 43 calendar days are insufficient for a quality implementation. They are being forced into rushed decisions, emergency costs and, in some cases, the risk of noncompliance at the deadline.

Why This Matters for Class II and Class I

If you manage Class II or Class I devices, you may be thinking, "I still have time." Technically, yes. The deadlines are:

• Class II: 10 January 2027 (14 months)
• Class I: 10 January 2028 (26 months)

Here is the problem: having time available is not the same as having enough time. The arithmetic is unforgiving for companies underestimating implementation complexity.

The Domino Effect Nobody Told You About

When Class III requirements take effect in January 2026, a predictable sequence will follow:

• Issuing agencies (GS1, HIBCC) will face increased demand for new registrations and technical support.
• Printers specialising in medical device labels will have their capacity tested.
• Regulatory consultancies will have full schedules.
• Traceability system suppliers will have longer implementation lead times.

What does this mean? When Class II companies begin seeking solutions in mid-2026, they will find longer lead times, higher costs and less individual attention. When Class I enters the picture in 2027, the situation will become even more critical.

Class I: the Quiet Challenge of Scale

Class I device companies frequently have extensive portfolios, with dozens or hundreds of SKUs (product references). Each size, colour, configuration or presentation variant needs its own unique UDI-DI code.

Consider this actual scenario: a surgical glove manufacturer has:

• 5 different models (latex, nitrile, vinyl, sterile and non-sterile).
• 8 sizes per model (PP, P, M, G, GG, XG, XXG, XXXG).
• 3 packaging types (50-unit box, 100-unit box, 10-box display).

Result: 120 different SKUs, each requiring a unique UDI-DI, a redesigned label, system registration and team training.

Class I rule of thumb: if you have 1,000 SKUs and can process 50 a month (code generation, redesign, production and implementation), you need 20 months of continuous work. Add 6 months for planning, testing and adjustments, and you reach 26 months, exactly the entire period available until January 2028.

Starting in January 2027? Mathematically impossible for large portfolios. You will face the same panic Class III is experiencing now.

The Hidden Costs of Late Implementation

Companies leaving implementation until the last minute pay more than the basic cost. They pay an invisible but substantial surcharge we call the urgency premium. Here is how costs multiply:

Increased Direct Costs

Actual example: a company with 50 Class III SKUs that planned ahead spent approximately R$ 45,000 on full implementation (codes, labels, consultancy, systems and training). A similar company waiting until November/December 2025 faces costs of R$ 65,000 to 70,000, an increase of 44 to 55% purely through lack of planning.

Indirect Costs (the Worst)

• Rework: labels mass-produced with errors because there was insufficient review time.
• Operational paralysis: production stopped while awaiting new labels or codes.
• Lost sales: inability to market products after the deadline.
• Reputational damage: customers (hospitals and distributors) losing confidence in your compliance capability.
• Regulatory risk: ANVISA fines may range from R$ 2,000 to millions of reais, alongside suspension of marketing.

The real cost of late implementation lies beyond the extra 40 to 50% paid to suppliers. It lies in interrupted sales, rework, errors and regulatory exposure.

Understanding UDI: the Basics You Need

UDI functions as a "digital identity" for each medical device. It has two main elements.

UDI-DI (Device Identifier)

This is the unique, permanent code identifying a specific device model/version. Think of it as the product's "CPF" (Brazilian individual taxpayer number): unique and unchanging.

When it changes: when a modification affects safety or performance (material, critical design, sterilisation or shelf life). Minor variations (batch or manufacturing date) do NOT change the UDI-DI.

Example: a "CardioFlow Pro" coronary stent, size 3.0mm x 18mm, has a specific UDI-DI. All batches of the same stent (same size, material and specification) share that UDI-DI. A new 3.0mm x 24mm version requires a new UDI-DI because its size differs.

UDI-PI (Production Identifier)

This is the variable information identifying a particular unit or batch:

• Batch number.
• Serial number for individually traceable devices.
• Manufacturing date.
• Expiry date.

Requirement: UDI-PI is mandatory only for Class III devices and some Class II devices where traceability is required (implantable, life-supporting and reusable devices). For many Class II and most Class I devices, only UDI-DI is needed.

Choosing an Issuing Agency: GS1 vs HIBCC

ANVISA recognises three main international issuing agencies: GS1, HIBCC and ICCBBA. ICCBBA/ISBT 128 specifically covers products of human origin (blood, tissues, cells and organs for transplantation) and does NOT apply to the vast majority of conventional medical devices such as stents, catheters, orthopaedic implants and equipment.

For conventional medical devices, the practical choice is between GS1 and HIBCC. This decision has significant cost and long-term strategic implications.

Detailed Comparison: GS1 Brasil vs HIBCC

Strategic Analysis: Which Should You Choose?

Choose GS1 if:

• Your main market is Brazil and Latin America.
• You value local support in Portuguese.
• Your company already uses GS1 barcodes (EAN).
• You want maximum compatibility with Brazilian distributors/hospitals.

Choose HIBCC if:

• You export or plan to export to the US/FDA market.
• You prefer predictable fixed costs, with a one-off fee and no annual surprises.
• Your portfolio is small/medium and stable.
• You can work with support in English.

Special case: small companies and MEIs: GS1 offers turnover-based categories (MEIs earning up to R$ 81K/year pay only R$ 550/year). However, HIBCC may offer a long-term advantage through the absence of recurring annual fees. Do the calculation: over 10+ years, a US$ 218 one-off fee (R$ 1,100) versus R$ 5,500 accumulated over 10 years with GS1 can make a significant difference to microbusinesses.

Caution: whichever agency you choose, ensure it is officially recognised by ANVISA. Codes from unrecognised agencies do NOT meet RDC 591/2021 and may result in noncompliance.

Regulatory Timetable: How Much Time You HAVE vs How Much You NEED

RDC 884/2024 established the following mandatory UDI deadlines:

Here is what that means in actual implementation time.

Class III (Deadline: 43 days) - Status: CRITICAL

• Companies that have not started face a real risk of noncompliance at the deadline.
• Emergency implementation is required, with all associated costs and risks.
• No margin for error or rework.

Class II (Deadline: 14 months) - Status: URGENT

It looks comfortable, but it is NOT after deducting:

• Year-end 2025 holidays and collective shutdowns (2 weeks).
• Carnival 2026 (1 week).
• Mid-year collective shutdowns (2 weeks).
• Year-end 2026 holidays (2 weeks).

Total time lost: ~7 weeks, or 1.75 months. Actual available time: ~12.25 months for full implementation. With 2.5 to 4.5 months of effective work required, there is a safety margin, but no room for procrastination.

Recommendation: begin in Q1 2026 (January to March). This allows gradual implementation, proper testing and corrections without panic.

Class I (Deadline: 26 months) - Status: PLANNING NEEDED NOW

26 months looks generous, but the arithmetic is tight for large portfolios.

Practical calculation:

1. Count your SKUs, including ALL variants.
2. Estimate how many SKUs your team can process monthly, averaging 40 to 60 for established companies.
3. Divide: total SKUs ÷ SKUs per month = months required.
4. Add 6 months for planning, agency selection, system setup, testing and adjustments.

Actual examples:

• 100 SKUs: (100 ÷ 50) + 6 = 8 months → starting in May/2027 is safe.
• 500 SKUs: (500 ÷ 50) + 6 = 16 months → starting in Sept/2026 is necessary.
• 1,000 SKUs: (1,000 ÷ 50) + 6 = 26 months → starting NOW (Nov/2025) is essential.
• 2,000+ SKUs: mathematically IMPOSSIBLE without starting immediately and/or increasing processing capacity.

If you have more than 500 Class I SKUs, starting in 2027 means leaving it until the last minute. The apparent spare time is an illusion created by your portfolio's scale.

Imported Devices: Who Is Responsible for UDI?

A frequent question from importers and distributors: if the international manufacturer already has a UDI, can it be used in Brazil?

Answer: it depends.

Scenario 1: the International Manufacturer Has UDI from a Recognised Agency

Situation: the foreign manufacturer has already implemented UDI using GS1, HIBCC or ICCBBA, agencies recognised by ANVISA.

Solution: the importer/distributor/registration holder MAY use the manufacturer's existing UDI, provided:

• Codes are visible and legible on the labelling arriving in Brazil.
• Labelling meets RDC 185/2001 requirements (Portuguese language and mandatory information).
• The Brazilian registration holder registers the UDI in SIUD when the system becomes operational.

Advantage: significantly lower costs and lead times. New codes are unnecessary; Brazilian label compliance and SIUD registration must simply be ensured.

Scenario 2: the Manufacturer Has NO UDI or Uses an Unrecognised Agency

Situation: the international manufacturer has not implemented UDI or uses an issuing agency not recognised by ANVISA.

Responsibility: the Brazilian registration holder, generally the importer or legal representative, MUST:

1. Engage a recognised issuing agency (GS1 or HIBCC).
2. Generate UDI-DI codes for each device.
3. Ensure Brazilian labelling includes UDI codes, using an additional label if needed.
4. Register in SIUD.

Caution: importers and distributors working with manufacturers without UDI face the SAME challenges, costs and timelines as local manufacturers. Do not underestimate this complexity.

Scenario 3: Own-brand Devices (White Label)

Situation: you import devices and market them under your own brand in Brazil.

Responsibility: YOU, the brand owner, are legally responsible for generating and applying UDI codes, even if the original manufacturer has its own codes.

Strategic recommendations for importers:

• Include UDI clauses in new import contracts.
• For existing portfolio products, negotiate with manufacturers to implement globally recognised UDI, simplifying your operation.
• If the manufacturer does not cooperate, compare local implementation costs with finding alternative suppliers that already have UDI.

SIUD: Brazil's UDI Registration System

Alongside applying UDI codes to labels, RDC 591/2021 requires registration of this information in SIUD, the National Unique Device Identification System, a national database managed by ANVISA.

Current SIUD Status (November 2025)

SIUD remains under development. ANVISA completed the pilot's first phase in September 2024, testing basic functions with volunteer companies. However, the operational Normative Instruction defining registration procedures, data formats and validations has not yet been published.

What this means in practice:

• Class III companies facing the Jan/2026 deadline should first focus on mandatory UDI labelling.
• SIUD registration will be required later, once the system is operational.
• Historically, ANVISA provides a reasonable interval between IN publication and mandatory registration.

What We Know About SIUD

• It will resemble international systems such as GUDID (FDA/US) and EUDAMED (Europe).
• Expected fields: UDI-DI, manufacturer name, trade name, model, risk class, GMDN code (global nomenclature), size/configuration, sterilisation information and single-use/reusable status.
• It will probably allow bulk uploads through files (CSV/XML) for companies with many SKUs.
• Access will be through a web platform, similar to ANVISA systems such as Datavisa.

Critical point: even without the IN published, 90% of preparation can be completed now:

1. Select an issuing agency and generate UDI-DI codes.
2. Update labelling with UDI codes.
3. Organise an internal database containing all information SIUD will require.
4. Integrate UDI codes into internal systems (ERP, WMS and traceability).

When the IN is published and SIUD opens for registration, companies that have prepared will only need to upload data, a matter of days. Those who waited will be months behind.

FAQ: the 15 Most Frequently Asked Questions About UDI

Based on hundreds of enquiries received by regulatory consultancies and discussions in ANVISA webinars, these are the real questions industry professionals face.

1. Can my current EAN barcode serve as a UDI?

NO. Although EAN-13, the common product barcode, is issued by GS1 and could technically provide a foundation, UDI requires specific formatting and additional data, including UDI-PI where applicable. You must request suitable GTIN codes for medical devices and follow the UDI standard. Existing barcodes cannot simply be reused as they are.

2. My international manufacturer already has UDI. Can I use it in Brazil?

YES, if the agency is recognised. If the manufacturer used GS1, HIBCC or ICCBBA, existing codes may be used provided labelling complies with Portuguese-language and mandatory ANVISA information requirements and you register in SIUD. If the agency is unrecognised, new codes are needed.

3. What happens if I miss the deadline?

You will be unable to market your devices. After the deadline, products without compliant UDI are considered noncompliant. This means:

• No legal sale/distribution.
• Risk of product seizure during enforcement inspections.
• ANVISA fines, from R$ 2,000 to millions depending on severity and repeat offences.
• Possible temporary suspension or cancellation of operating authorisation.

4. Do I need UDI-PI for every product?

NO. UDI-PI (batch number, serial number and dates) is mandatory only for:

• All Class III devices.
• Implantable or life-supporting Class II devices.
• Reusable devices requiring individual traceability.

For most Class II and practically all Class I devices, only UDI-DI is needed, without batch/serial information encoded in the barcode.

5. Can I outsource code generation?

NOT directly. You must be the official contracting party with the issuing agency (GS1 or HIBCC). Consultants can help with registration, documentation and implementation, but the legal relationship with the issuing agency must be yours. Be wary of "intermediaries" offering to sell codes; this is not permitted.

6. How long does receiving codes take after engaging the agency?

It varies by agency:

• GS1 Brasil: generally 5 to 10 working days after registration approval and payment.
• HIBCC: may take 2 to 3 weeks, involving an international process and English communication.

After receiving the base codes, you can instantly generate product-specific UDI-DI codes through the agency's tools/platforms.

7. Must I change ALL labels at once?

It depends on your strategy and deadline. There is no legal requirement to change everything simultaneously, but by the deadline (10 Jan for your class), ALL marketed products must have UDI. Common strategies:

• Gradual implementation: begin with the highest-volume or most significant products, then expand.
• Use existing label stock depletion: include UDI when renewing print orders.
• Consider temporary additional labels: UDI labels may provide a short-term solution for already labelled stock, subject to readability requirements.

8. My product has 50 colour/size variants. Do I need 50 codes?

Probably YES. Each variation affecting safety or performance, or marketed separately, requires its own UDI-DI. Exception: purely aesthetic variations, such as a scalpel handle colour that does not affect function, may share a code. When uncertain, consult the issuing agency or your regulatory consultancy.

9. Can I change issuing agencies later?

Technically YES, but it is complex and expensive. You would need to:

• Engage the new agency.
• Generate new UDI-DI codes for ALL products.
• Redesign and reprint ALL labels.
• Update SIUD registrations.
• Manage the old/new stock transition.

Therefore, choose carefully the first time. Consider long-term plans, including future exports and growth, before deciding.

10. How does batch traceability work without UDI-PI?

UDI-PI on the label is only ONE form of traceability. If your product does not require UDI-PI, as with most Class II and I devices, you can and should still maintain internal batch control through ERP/WMS systems. The distinction is that traceability remains in internal systems rather than being encoded in the product barcode.

11. Must I notify ANVISA before implementing UDI?

NOT formally. UDI implementation requires no prior ANVISA application or approval. You must:

• Implement it under RDC 591/2021.
• Update the product registration (labelling) through the normal post-registration change process where necessary.
• Register in SIUD when available.

12. Can stock without UDI be sold after the deadline?

Technically NO. Regulations require products marketed after the deadline to have UDI. Options:

• Apply UDI labels to existing stock where technically and regulatorily feasible.
• Work with distribution channels to clear old stock before the deadline.
• As a last resort, consider writing off stock that cannot be adapted in time.

Proper planning avoids this nightmare.

13. I have two manufacturers of the same product. Can I use the same UDI?

NO. Each manufacturer must generate its own UDI codes. Even identical products, such as a surgical mask from Factory A and Factory B, have separate unique UDIs. This is essential for traceability in adverse events.

14. What if my product has multiple packaging levels (unit, box, pallet)?

Each packaging level marketed/distributed separately requires its own UDI-DI:

• Individual product: its own UDI-DI.
• Box of 10 units: a different UDI-DI.
• Master carton of 10 boxes: another UDI-DI.

Use the GS1 GTIN-14 structure for packaging levels above the consumer unit.

15. Where can I obtain official answers about UDI?

Official channels:

• ANVISA GGTPS: ggtps@anvisa.gov.br, the area responsible for UDI.
• GS1 Brasil support: contato@gs1br.org / 0800-7707010.
• HIBCC Help Desk: info@hibcc.org.
• Webinars and technical materials on ANVISA and issuing agency websites.

Medical device regulatory consultancies such as HSC Global are also valuable sources for strategic questions and practical implementation.

Practical Guide: Implementing UDI in 8 Phases

Based on successful company implementations, this is a tried and tested methodology.

Phase 1: Assessment and Planning (2 to 3 weeks)

1. Compile a complete SKU inventory (products, variants and packaging).
2. Prioritise products by sales volume, criticality and regulatory complexity.
3. Establish a multidisciplinary team (quality, production, IT, sales and regulatory affairs).
4. Create a realistic timetable with milestones and owners.
5. Set the budget, including a 20% contingency.

Phase 2: Selecting and Engaging an Issuing Agency (1 to 2 weeks)

1. Compare GS1 and HIBCC for costs, target markets and support.
2. Request formal quotations and lead times.
3. Verify official ANVISA recognition.
4. Engage the agency and complete registration/licensing.
5. Await approval and access to the code generation platform.

Phase 3: Generating UDI-DI Codes (1 week)

1. List all products with their technical specifications.
2. Generate UDI-DI codes for each SKU using the agency's platform.
3. Document the mapping: UDI code ↔ product/internal reference.
4. Export the code database as a secure backup.

Phase 4: Label Redesign (3 to 4 weeks)

1. Engage a designer/graphics team experienced in medical devices.
2. Integrate UDI codes into the existing layout, considering space and readability.
3. Include a compliant barcode (Data Matrix recommended, Code 128 acceptable).
4. Review mandatory RDC 185/2001 information + UDI.
5. Obtain internal approval from quality, regulatory affairs and production.
6. Test barcode scanning with standard commercial scanners.

Phase 5: Producing New Labels (2 to 3 weeks)

1. Request printer quotations, comparing at least 3.
2. Supply final artwork with clear technical specifications.
3. Request a sample/proof before mass production.
4. Validate the sample for readability, durability and adhesion.
5. Approve production and monitor lead times.

Phase 6: Internal System Integration (2 to 4 weeks, potentially in parallel)

1. Update ERP with UDI codes, adding a product record field.
2. Configure WMS to recognise UDI codes at goods receipt and dispatch.
3. Adapt the traceability system if UDI-PI is used.
4. Update tax invoices and commercial documents to include UDI.
5. Test the full flow: receipt → production → dispatch.

Phase 7: Team Training (1 to 2 weeks)

1. Production: applying new labels and identifying UDI codes.
2. Quality: validating labelling compliance.
3. Stores/dispatch: reading and processing UDI codes.
4. Sales: communicating changes to customers.
5. Document procedures through updated SOPs.

Phase 8: Transition and SIUD Registration (1 to 2 weeks + waiting for the system)

1. Begin gradually applying new labels.
2. Manage the coexistence of old and new stock.
3. Monitor initial sales for customer feedback and operational issues.
4. Prepare SIUD registration data in a spreadsheet.
5. Once SIUD is available, complete registration.
6. Validate registered data against actual labelling.

MINIMUM TOTAL TIME: 11 to 18 weeks (2.5 to 4.5 months).

Looking Further: UDI in Latin America and Competitive Advantage

If you see UDI implementation as merely "ticking ANVISA's box", you are missing a significant strategic opportunity. Latin America is rapidly harmonising regulation, and UDI is central to that transformation.

Regional Overview

• Colombia (INVIMA): Resolution 1405/2022 established a phased timetable. Deadlines for lower risk classes run until February 2026.
• Argentina (ANMAT): as an observer member of IMDRF (International Medical Device Regulators Forum), it is developing UDI regulation. Estimated publication: 18 to 24 months. Mandatory implementation is likely in 2027-2028.
• Mexico (COFEPRIS): NOM-241, the Mexican Official Standard for medical devices, is being updated and will include UDI requirements.
• Ecuador (ARCSA): has already regulated UDI with phased deadlines similar to Brazil's.

The Competitive Advantage: One Code, Multiple Markets

The crucial point: the same UDI-DI codes generated for Brazil are valid and recognised in other countries adopting GS1, HIBCC or ICCBBA.

Companies implementing UDI NOW with a strategic outlook will therefore be automatically prepared to:

• Export to Colombia, Argentina, Mexico, Chile and Peru without significant additional regulatory work.
• Meet international buyer requirements (hospitals, networks and regional distributors).
• Participate in international tenders increasingly requiring UDI.
• Demonstrate global standards compliance as a competitive advantage.

While rushed competitors will have codes merely to "tick a box", you will have global traceability infrastructure ready.

The Definitive Lesson: Learning from Others' Mistakes

Return to the start of this article. Right now, Class III companies face:

• Costs 40 to 55% higher than necessary.
• Extreme operational stress during the year-end holidays.
• A real risk of noncompliance at the deadline.
• Rushed decisions without time for optimisation.
• Potential sales paralysis if they miss the deadline.

All of this was 100% avoidable through proper planning beginning 6 to 8 months earlier. They had almost 4 years from RDC 591/2021 publication. They had the July/2024 extension. Yet many waited until November/December 2025.

The critical question: will you repeat this mistake?

If you manage Class II devices, you have 14 months. It looks generous. It is not.

If you manage Class I devices with a large portfolio (500+ SKUs), you have 26 months. It looks comfortable. It is not.

After deducting periods of low productivity and allowing for the learning curve, inevitable setbacks and each implementation phase, your margin for error is smaller than you think.

What to Do NOW

If you have Class II devices:

• This week: complete your SKU inventory and estimate project scope.
• December 2025: define the strategy (issuing agency, budget and timetable).
• January to March 2026: execute phases 1 to 3 (planning, agency engagement and code generation).
• April to August 2026: redesign, production and system integration.
• September to December 2026: training, transition and final adjustments.
• January 2027: full compliance with a safety margin.

If you have Class I devices with an extensive portfolio (500+ SKUs):

• DECEMBER 2025: start planning IMMEDIATELY.
• Q1 2026: engage the agency and begin generating codes for priority products.
• Throughout 2026: continuous redesign and gradual transition.
• 2027: continue implementation for lower-priority products.
• Q4 2027: completion and full compliance.

If you have Class I devices with a small portfolio (up to 200 SKUs): you have greater flexibility, but this does NOT justify procrastination. Starting in Q2-Q3 2026 is reasonable. Waiting until 2027 creates unnecessary risk.

How HSC Global Can Help

HSC Global is a medical device regulatory affairs consultancy with a particular focus on Brazilian and international markets. Our team has proven experience in:

• Full UDI implementation, from agency selection to SIUD registration.
• Cost optimisation strategies to avoid the "urgency premium".
• Preparing for international expansion (Latin America, US and Europe).
• Training internal teams for regulatory autonomy.
• Portuguese-language support with in-depth knowledge of Brazilian conditions.

Do not wait to become another negative statistic. Companies approaching us 6 to 9 months in advance implement UDI calmly, economically and strategically. Those approaching us weeks before the deadline pay the urgency premium, and we cannot always rescue the situation.

Conclusion: Time Is the Most Valuable Resource

UDI is more than a regulatory requirement. It fundamentally transforms how the medical device industry operates, bringing traceability, transparency and safety for patients and healthcare professionals.

Companies treating it as an opportunity to optimise processes, prepare international expansion and demonstrate regulatory excellence will emerge stronger. Those treating it as "bureaucracy to deal with at the last minute" will pay dearly in money, stress and reputation.

The difference between the two groups lies in planning and early execution, rather than financial resources or company size.

You have a choice now:

• Option A: delay, procrastinate, wait for "the right moment" and discover too late that the right moment was now.
• Option B: act intelligently, start planning this week and join the companies that implemented UDI to an exemplary standard.

Class III companies have already made the wrong choice. They are paying the price. Do not follow them.