Medical Device Regulation in Latin America: A Comparative Analysis of Brazil, Mexico, and Costa Rica (2026)

Quick answer

What are the medical device registration requirements in Latin America in 2026?

Latin America combines three distinct regulatory architectures. Brazil (ANVISA) uses bifurcated Notification/Registration pathways under RDC 751/2022, with MDSAP compressing BGMP certification from 18–24 months to 6–9 months for Class III/IV devices. Mexico (COFEPRIS) launched an Equivalency (Abbreviated) Route effective September 1, 2025, targeting 30 business days for devices with FDA, CE, Health Canada, or other IMDRF/MDSAP-recognised approvals. Costa Rica aligns classification with Health Canada, submits via the Registrelo portal, and offers a simplified pathway for US FDA-cleared devices. All three require a local registration holder (BRH, MRH, or authorised importer), Spanish or Portuguese documentation, and carry distributor hostage risk if commercial distributors hold licences.

Keywords: medical device registration Latin America 2026, ANVISA Brazil medical device, COFEPRIS Mexico registration, Costa Rica EMB registration, MDSAP Latin America, Registrelo portal Costa Rica, DIGIPRIS Mexico, Notification Registro Brazil, Mexico Registration Holder, Brazil Brazilian Registration Holder, distributor hostage Latin America, CE marking Latin America, ISO 13485 LATAM, medtech regulatory affairs Latin America, LGPD Brazil medical device, UDI Brazil

Abstract

Latin America represents one of the most commercially significant and regulatory diverse regions in the global medical device industry. Brazil — the region's largest economy and market — has undergone substantial regulatory modernisation in recent years under ANVISA, introducing a bifurcated Notification/Registration architecture codified in RDC 751/2022 and leveraging the Medical Device Single Audit Program (MDSAP) to streamline Good Manufacturing Practice certification. Mexico, the region's second-largest market and a key node in global manufacturing supply chains, has implemented a transformative Abbreviated (Equivalency) Pathway through COFEPRIS effective September 2025, compressing registration timelines for internationally approved devices from months to a targeted 30 business days. Costa Rica, while smaller in scale, presents a strategically distinct environment characterised by alignment with Health Canada's classification model, a fully digitised submission system (Registrelo), and a simplified pathway for US FDA-cleared devices that reduces review workload significantly. This article synthesises publicly available regulatory intelligence and practitioner expert insights published in 2025 and 2026 across these three jurisdictions, providing regulatory affairs professionals and medtech market access teams with a structured, academically grounded comparative overview current as of mid-2026.

1. Introduction

Latin America's medical device regulatory landscape is shaped by the interplay of national health priorities, institutional capacity, and increasing engagement with international harmonisation frameworks including the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP). The three markets covered in this analysis — Brazil, Mexico, and Costa Rica — illustrate the range of regulatory approaches within the region: from a large, independent, and highly developed framework (Brazil's ANVISA) to a medium-sized market undergoing rapid liberalisation through reliance (Mexico's COFEPRIS), and a smaller market with a surprisingly sophisticated digital infrastructure and strong international alignment (Costa Rica's Ministry of Health, Directorate DRPIRS).

For medical device manufacturers building multi-country Latin American strategies, understanding the specific architecture of each framework — its classification logic, registration pathways, local representative requirements, digitalization maturity, and unique regulatory risks — is essential. A strategy built on assumptions from one market will frequently fail in another. This article addresses that need through a systematic jurisdiction-by-jurisdiction analysis, followed by cross-cutting comparative observations.

A note on nomenclature: Costa Rica uses the term Equipo y Material Biomédico (EMB) — Biomedical Equipment and Material — rather than "medical device." Throughout this article, the term "medical device" is used generically across all three jurisdictions for clarity.

2. Brazil: ANVISA's Bifurcated Pathways, MDSAP Leverage, and LGPD Compliance

2.1 Regulatory Authority and Legal Framework

Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA) — the National Health Surveillance Agency — an autonomous body linked to the Ministry of Health, established in 1999. ANVISA has sole national authority over medical device classification, registration, Good Manufacturing Practice (GMP) certification, importation, post-market surveillance, and adverse event reporting. There is no delegated state-level authority for medical device registration; ANVISA's jurisdiction is centralised and uniform across the country.

The primary legislative instruments for medical devices as of 2026 are:

• RDC No. 751/2022 (effective March 1, 2023): The core regulation governing risk classification, registration pathways, labelling, notification, and marketing authorisation for general medical devices, replacing the longstanding RDC 185/2001.
• RDC No. 830/2023 (effective June 1, 2024): The companion regulation for In Vitro Diagnostic (IVD) devices, replacing RDC 36/2015.
• RDC No. 657/2022: The specific framework for Software as a Medical Device (SaMD).
• RDC No. 591/2021: UDI requirements.

2.2 Classification System

Brazil employs a four-tier, risk-based classification system (Classes I through IV), governed by 22 classification rules in Annex I of RDC 751/2022, which consider intended purpose, duration of use (transient: under 60 minutes; short-term: 60 minutes to 30 days; long-term: over 30 days), invasiveness, and energy delivery characteristics. Where doubt exists, ANVISA determines the class. The split between Class II and Class III is commercially significant, as it delineates the boundary between notification (a simpler, documentary pathway) and full marketing authorisation (a comprehensive technical review).

2.3 Registration Pathways: Notification vs. Registration

The bifurcation between pathways is the defining structural feature of Brazil's medical device regulatory architecture:

Notification (Cadastro) — Classes I and II: Lower-risk devices follow a simplified notification pathway. The Brazilian Registration Holder (BRH) submits a streamlined dossier; ANVISA conducts a documentary review rather than a substantive technical evaluation. Effective review time is typically 30 to 90 days. Notification authorisations carry indefinite validity but may be cancelled for non-compliance.

Full Marketing Authorisation (Registro) — Classes III and IV: Higher-risk devices require submission of a comprehensive technical dossier, including clinical data (typically via literature review or investigations compliant with ISO 14155:2020), GMP certification, labelling in Portuguese, and other supporting documentation. Authorisations are valid for 10 years (renewable). The most significant time driver at this level is not the ANVISA dossier review itself, but the Brazilian Good Manufacturing Practice (BGMP/BPF) certification required for Class III and IV manufacturers.

2.4 MDSAP as the Critical Accelerator for Class III/IV

For Class III and IV devices, BGMP certification issued by ANVISA following a manufacturing site inspection is mandatory. Without MDSAP, ANVISA dispatches its own inspectors to the facility — a process with a historically documented waiting list of 18 to 24 months for first-time inspections, making this the dominant bottleneck in Brazil market access for higher-risk devices.

The transformative mitigation is MDSAP (Medical Device Single Audit Program), which ANVISA formally recognised under RDC 745/2022. A valid MDSAP audit report, accepted by ANVISA, substitutes for the on-site inspection, compressing BGMP certification to approximately 6 to 9 months from submission. For manufacturers already participating in MDSAP markets (US, Canada, Australia, Japan), the incremental cost of extending MDSAP scope to Brazil is substantially lower than bearing a standalone ANVISA inspection. Expert practitioner commentary from 2026 identifies MDSAP participation as the single most important strategic decision for manufacturers targeting Class III/IV market access in Brazil.

A key clarification: MDSAP does not waive ANVISA's government BGMP fee (BRL 72,805 / approximately USD 13,737); it waives only the on-site inspection requirement. The fee must still be paid.

2.5 The Brazilian Registration Holder and Fee Structure

Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) — a Brazilian legal entity — as the licence holder and regulatory interface with ANVISA. The BRH is responsible for submission, fee payment, adverse event reporting, post-market surveillance, and maintenance of the registration. Government fees as of 2026 are structured by class and product family:

• Classes I/II (Notification): BRL 1,406 per product (approximately USD 265)
• Classes III/IV (Registration — standard family): BRL 8,510 per product (approximately USD 1,607)
• Classes III/IV (Registration — large family): BRL 19,856 per product (approximately USD 3,747)

An important and Brazil-specific feature identified in the 2026 expert interview series is ANVISA's "representative size" fee model: certain fee categories are linked to the size or revenue classification of the local representative entity, creating a financial incentive to evaluate BRH selection not only on regulatory expertise but on the fee implications of the representative's corporate profile.

2.6 UDI Implementation Timeline

Brazil's Unique Device Identifier (UDI) requirements under RDC No. 591/2021 are being phased in by risk class:

Manufacturers with Class III or IV products already marketed in Brazil were required to implement UDI by January 2026. This represents an active compliance obligation for products already on market.

2.7 Software as a Medical Device and LGPD

Brazil's SaMD regulatory framework under RDC 657/2022 classifies standalone software independently using the general rules in RDC 751/2022, with Classes I/II following the notification pathway and Classes III/IV requiring full marketing authorisation. In-house SaMD developed and used exclusively within health services at low to moderate risk is exempt from registration but must maintain validation records for 10 years.

Of particular significance for SaMD manufacturers is the intersection of ANVISA's technical requirements with Brazil's General Data Protection Law (Lei Geral de Proteção de Dados — LGPD), which governs the processing of personal data including health data. Digital health applications and AI-enabled devices that collect or process patient data must demonstrate compliance with LGPD's data minimisation, consent, and data subject rights provisions in addition to ANVISA's cybersecurity and performance requirements. This dual compliance obligation is increasingly flagged in 2026 practitioner commentary as a significant planning consideration for digital health entrants.

2.8 Combination Products

Products that combine a drug and a device component (e.g., drug-eluting stents, prefilled syringes) are subject to jurisdictional determination by ANVISA based on the primary mode of action. The classification of combination products as drug-led or device-led determines the applicable regulatory pathway and the primary review unit within ANVISA. Expert commentary recommends early pre-submission consultation with ANVISA on combination product classification to avoid pathway errors with significant timeline consequences.

2.9 Post-Market Obligations

All authorisation holders are required to conduct ongoing post-market surveillance and report adverse events through Brazil's National System of Health Surveillance (SNVS). INMETRO certification (Instituto Nacional de Metrologia) is additionally required for active medical devices with electrical components subject to IEC 60601 standards, regardless of ANVISA classification. ANATEL (National Telecommunications Agency) certification applies to devices incorporating wireless communication technologies (Bluetooth, Wi-Fi, cellular, NFC, RFID).

3. Mexico: COFEPRIS, the DIGIPRIS Portal, and the Landmark 2025 Equivalency Reform

3.1 Regulatory Authority and Legal Framework

Medical devices in Mexico are regulated by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) — the Federal Commission for the Protection against Sanitary Risks — a deconcentrated body within the Secretariat of Health (Secretaría de Salud). COFEPRIS enforces requirements under two primary instruments: the General Health Law (Ley General de Salud) and the associated health regulations governing medical devices, IVDs, and sanitary registration processes.

3.2 Classification System

Mexico employs a risk-based classification framework using three main categories (Class I: Low Risk; Class II: Moderate Risk; Class III: High Risk), with classification determined by factors including intended use, contact with the body, invasiveness, and duration. COFEPRIS publishes registration fees by class:

• Class I (Low Risk): USD 650
• Class II (Moderate Risk): USD 1,000
• Class III (High Risk): USD 1,250

Initial registrations are valid for five years; subsequent renewals may be granted for up to ten years under updates effective January 2026.

3.3 Registration Pathways: Standard Route and Equivalency Route

Mexico offers two primary registration pathways:

Standard Route: A full technical dossier submission including clinical evidence, design specifications, quality system documentation, labelling in Spanish, and a Free Sale Certificate or Certificate to Foreign Government. Review timelines vary from 30 days for low-risk devices to six months or more for Class III products. Applications going through the standard route are eligible for Third Party Review (TPR), where accredited independent bodies pre-approve applications before COFEPRIS review — reducing timelines but adding cost.

Equivalency (Abbreviated) Route: The most significant regulatory development in Mexico in recent years is the operationalisation of the Abbreviated Regulatory Pathway (Equivalency Route), formally launched September 1, 2025. Under this pathway, manufacturers holding prior approval from an IMDRF- or MDSAP-recognised authority — including the US FDA, Health Canada, EU CE marking (MDR, IVDR, MDD, IVDD), Swissmedic, TGA (Australia), MFDS (Korea), NMPA (China), and others — may submit a summary dossier rather than a full technical file. COFEPRIS targets a 30 business day review period for complete submissions under this pathway.

This represents a fundamental shift. As recently as 2024, Mexico registration timelines under any pathway averaged months, with significant backlogs. The September 2025 reform has materially changed the calculus for manufacturers with pre-existing international approvals. For devices approved by FDA or Health Canada, Mexico has become one of the most accessible regulatory entry points in Latin America, and strategists are increasingly positioning Mexico as a gateway market for broader regional expansion.

The product submitted must be identical to the device approved by the reference authority; any modifications require reversion to the Standard Route.

3.4 The DIGIPRIS Digital Portal and Digitalization Challenges

Mexico's digital submission environment centres on the DIGIPRIS portal — COFEPRIS's online platform for registration applications, post-market notifications, and regulatory interactions. Expert practitioner commentary from 2026 identifies DIGIPRIS as a system that has undergone significant development but continues to present operational challenges: system downtime, inconsistent user experience, and submission workflow complexity that rewards familiarity with the platform. Practitioners advise that navigating DIGIPRIS effectively is a skill requiring dedicated experience and is a material factor in selecting a Mexico Registration Holder.

3.5 The Mexico Registration Holder and Distributor Hostage Risk

All foreign manufacturers must appoint a Mexico Registration Holder (MRH) — a Mexican legal entity — to submit applications, pay fees, and act as the local regulatory contact with COFEPRIS. Sanitary registrations are issued in the name of the MRH. Transferring a registration to a new MRH requires a formal process with COFEPRIS.

Expert practitioner interviews from 2026 explicitly identify the "distributor hostage" risk in Mexico as a central strategic concern: when a commercial distributor is appointed as the MRH, the registration certificate is held in the distributor's name. If the commercial relationship breaks down, the manufacturer's access to its own registration — and thus its ability to market the device — is contingent on the distributor's co-operation. The recommended practice is to appoint an independent regulatory entity as the MRH, structurally separate from the commercial distribution arrangement, with explicit contractual provisions governing registration transfer.

3.6 Leveraging Equivalence and Strategic Grouping

Mexico's equivalency framework accepts MDSAP certification as evidence of compliance with Mexico's GMP standard (NOM-241), meaning manufacturers already holding MDSAP certification for other markets do not need to build a parallel Mexican GMP compliance programme. ISO 13485, while not legally mandatory, is widely accepted as quality system evidence and satisfies COFEPRIS's NOM-241 equivalency pathway.

A further strategic tool available in Mexico is family grouping: COFEPRIS permits manufacturers to register related device variants — differing in size, colour, or specification within a defined product family — under a single sanitary registration. Effective grouping strategy can materially reduce registration costs and timelines for manufacturers with broad product portfolios.

3.7 Post-Market Vigilance and Language Requirements

All submissions, labelling, and Instructions for Use must be in Spanish. Post-market obligations include adverse event reporting through COFEPRIS's technovigilance system, product recalls, and Field Safety Corrective Actions. Registration holders are responsible for maintaining post-market surveillance systems throughout the product's lifecycle.

4. Costa Rica: Ministry of Health EMB Framework, Registrelo, and Health Canada Alignment

4.1 Regulatory Authority and Legal Framework

Medical device regulation in Costa Rica is administered by the Ministry of Health (Ministerio de Salud), specifically through the Directorate of Regulation of Health Products and Health Risk (DRPIRS). Devices are classified and registered under Decree No. 34482-S — the Regulation for the Registration, Classification, Import, and Control of Medical Devices — and related amendments.

Notably, Costa Rica uses the term Equipo y Material Biomédico (EMB) to designate what other jurisdictions call a medical device. This encompasses instruments, devices, equipment, materials, software, or any article intended for medical purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, provided the product does not achieve its principal intended action by pharmacological, immunological, or metabolic mechanisms. Software is explicitly within scope, a point of regulatory significance for digital health manufacturers.

DRPIRS is actively strengthening its regulatory capabilities with technical support from the Pan American Health Organization (PAHO) and is working toward WHO Level 2–3 regulatory authority status. Resolution DM-1725-2026, effective April 1, 2026, extended the validity of certain sanitary registrations by one year — an example of the Ministry's pragmatic approach to managing registration infrastructure constraints.

4.2 Classification System: Health Canada Alignment

Costa Rica's classification system is modelled closely on Health Canada's four-tier risk framework, based on PAHO guidance for Latin American regulatory harmonisation. This is distinctive within the Latin American context, where most jurisdictions follow a classification architecture more closely aligned with FDA or EU MDR.

• Class I (Low Risk): Since Decree No. 43902-S (effective September 9, 2023), all Class I EMBs are exempt from sanitary registration for commercialisation. However, they remain subject to import, labelling, advertising, surveillance, and control requirements.
• Class II (Moderate Risk): Basic documentation required; registration mandatory.
• Class III (Moderate-High Risk): Additional clinical and performance data required beyond Class II.
• Class IV (High Risk): Most comprehensive dossier; enhanced clinical evidence and performance data required.

Registration validity is five years across all registerable classes.

4.3 The Registrelo Digital Portal

The Registrelo portal is the Ministry of Health's digital submission platform for EMB registration and a range of other health product applications. Expert practitioner commentary — including from a former Ministry of Health evaluator consulted in 2026 — identifies Registrelo as one of the most operationally efficient submission systems in the Latin American region.

Key features of the system include:

• Digital signature requirement: Authorised users (local representatives) must hold and use a digital signature to submit applications.
• Near-instantaneous processing of administrative modifications: Amendments that previously required months of processing through paper-based systems are resolved within hours on Registrelo.
• Real-time customs integration: Costa Rican customs authorities (via PROCOMER, the Foreign Trade Promoter) can access Registrelo in real time to verify that imported devices are registered and that the importer is authorised — eliminating the need for physical documentation at the border.
• Public consultation features: Registrelo is openly consultable by any person, supporting market research, competitor analysis, and regulatory intelligence gathering. Registered users may generate PDF or spreadsheet reports directly from the system.

This digital infrastructure places Costa Rica ahead of several larger markets in the region in terms of submission efficiency and customs integration.

4.4 The US FDA Simplified Pathway and Workload Reduction

A practitioner-identified feature of particular value to manufacturers with US FDA clearance or approval is Costa Rica's FDA simplified pathway: submissions supported by US FDA documentation benefit from a materially reduced technical review burden, as DRPIRS places significant reliance on the FDA's prior scientific assessment. This mirrors the reliance logic of Singapore's HSA or Malaysia's MDA abridged pathway in the Asia-Pacific context, and makes Costa Rica an efficiently accessible market for manufacturers already cleared in the United States.

4.5 Free Sale Certificate Requirements and Common Administrative Traps

The Free Sale Certificate (FSC) — or an equivalent Certificate of Export or Certificate to Foreign Government — is a central documentation requirement for Costa Rican EMB registration. The FSC must indicate the specific device name to be registered, confirm that the product is freely sold in the country of origin, be signed by the responsible authority in the country of origin, and be notarised and consularised (apostilled/authenticated for international use).

Expert practitioner commentary from 2026 — provided by a former Ministry of Health evaluator — specifically identifies FSC-related errors as among the most frequent causes of application rejection or delay:

• Generic FSCs: Certificates that reference a product family broadly rather than naming the specific device being registered are commonly rejected. The FSC must be product-specific.
• Missing notarisation or consularisation: Documents that are signed but not appropriately authenticated for international use are returned for correction.
• Outdated validity: FSCs that have expired or that post-date the intended commercialisation period are flagged.

Preparation of the FSC package — including co-ordination with the relevant authority in the country of origin and any applicable embassy or apostille authorities — should be initiated well in advance of the submission target date.

4.6 Drug-Device Combinations and Unique Product Inclusions

Under Costa Rica's EMB regulatory scope, certain product categories that are regulated differently in other jurisdictions fall within the medical device (EMB) framework in Costa Rica. This includes some drug-device combination products and materials that may be classified as pharmaceuticals elsewhere. Expert practitioners advise careful pre-classification review for products at the device-drug boundary, as the regulatory pathway and responsible authority within the Ministry of Health may differ from what a manufacturer expects based on experience in other markets.

4.7 Local Representation and Market Entry Considerations

All medical device imports and commercialisation must be handled by a national manufacturer or an importer authorised by the Ministry of Health with a current operation permit. The local representative must be a Costa Rican legal entity and serves as the Registration Holder for regulatory purposes. The independent representative model — separating regulatory representation from commercial distribution — is equally applicable in Costa Rica as in other markets, given the licence transfer implications of distributor-held registrations.

4.8 Public Procurement and CCSS Requirements

The Caja Costarricense de Seguro Social (CCSS) — Costa Rica's social security fund — manages public healthcare procurement and is the dominant purchasing channel for medical devices in the public hospital sector. CCSS requires barcode identification on all purchases of medicines and medical supplies, making UDI/barcode compliance a practical commercial prerequisite for manufacturers targeting the public hospital market, even where it is not mandated by the DRPIRS registration process itself.

5. Comparative Analysis

5.1 Classification Architecture

All three markets employ risk-based classification systems, but with different reference models and tier counts:

The Brazil Class II/III threshold is the most operationally consequential classification boundary in the region: crossing it triggers the shift from a simple notification to a comprehensive registration with BGMP certification requirements that can add 6 to 24 months to the market access timeline.

5.2 International Approval Leverage

All three markets benefit from, and in different ways formalise, reliance on prior international approvals:

Mexico's 2025 Equivalency reform is the most explicit and transformative reliance mechanism of the three, compressing timelines from months to a targeted 30 days for a broad range of international approvals. Brazil's MDSAP recognition is equally critical at the GMP certification level, though it does not create an abridged registration review pathway comparable to Mexico's. Costa Rica's FDA alignment is practical and significant for US-market manufacturers, though less formally codified than Mexico's equivalency framework.

5.3 Digitalization Maturity

Costa Rica's Registrelo is notable for its level of integration with customs and its public consultation functionality — features that exceed what much larger regional markets have achieved. This is an example of a smaller market achieving regulatory digitalization leadership through focused investment.

5.4 Local Representative Risk: The Distributor Hostage Problem

All three markets require a local legal entity as the registration holder, and all three carry a version of the distributor hostage risk:

• Mexico — COFEPRIS explicitly names this risk; MRH holds the sanitary registration; transfer requires formal process.
• Brazil — BRH holds the ANVISA authorisation; the "representative size" fee model adds a dimension absent elsewhere.
• Costa Rica — Local authorised importer holds the registration; smaller market but the structural risk is the same.

The consistent best-practice across all three markets — and indeed across the global regulatory landscape — is to appoint an independent regulatory consultant or entity as the registration holder, with commercial distribution arrangements governed separately and with explicit contractual provisions for registration transfer.

5.5 Language Requirements

All three jurisdictions require documentation and labelling in the local official language:

Brazil's Portuguese requirement distinguishes it from Mexico and Costa Rica, adding a translation step for manufacturers whose documentation is prepared in Spanish for other Latin American markets.

5.6 Timeline Comparison

6. Strategic Implications for Regulatory Affairs Practice

6.1 Invest in MDSAP Before Entering Brazil at Class III/IV

For manufacturers targeting Brazil's Class III or IV device market, MDSAP participation is not merely advantageous — it is the primary determinant of whether market access is achievable within a commercially viable timeframe. The difference between an 18–24-month BGMP inspection backlog and a 6–9-month MDSAP-supported process is the difference between a viable market entry and a project that cannot support a business case. For manufacturers already selling in any two or more of the US, Canada, Australia, or Japan, the incremental cost of extending MDSAP scope to cover Brazil is almost always justified.

6.2 Treat Mexico as the Latin American Gateway After September 2025

The COFEPRIS Equivalency Route reform of September 2025 has materially changed Mexico's strategic position in Latin American market access planning. For manufacturers holding FDA clearance, EU CE marking, or approval from any of the now broadly recognised IMDRF/MDSAP reference authorities, Mexico has become one of the most accessible entry points in the region — with a targeted 30 business day review timeline and a summary dossier requirement rather than a full technical file. Manufacturers with established US or European approvals should review their Latin American sequencing strategies to capitalise on this pathway before competitive dynamics change.

6.3 Use the Registrelo System's Transparency for Market Intelligence

Costa Rica's Registrelo portal offers publicly accessible consultation of all registered EMBs, importer authorisations, and product approvals. This is an underutilised market intelligence resource: regulatory affairs teams can use the system to identify registered competitors, assess market penetration, and research the registered status of product categories before committing to registration resources. This level of public transparency is unusual in the global regulatory landscape and is a distinctive advantage of the Costa Rican framework.

6.4 Structure Local Representation to Separate Regulatory and Commercial Functions

Across all three markets, the distributor hostage risk is real and well-documented in 2026 practitioner literature. Contract design — particularly provisions governing registration holder co-operation on transfer, NOC issuance timelines, and breach consequences — should be negotiated and executed before the initial registration submission. Once a registration is in place in a distributor's name, the manufacturer's negotiating position weakens. Independent registration holders, while an additional operational layer, eliminate the leverage asymmetry that a combined distributor/registration holder arrangement creates.

6.5 Prepare FSC Documentation Well in Advance in Costa Rica

The FSC authentication chain for Costa Rica — product-specific naming, signature by a recognised authority, notarisation, and consularisation — involves multiple entities and meaningful lead time. For manufacturers accustomed to submitting generic or template FSCs in other markets, the specificity requirements of Costa Rica's system are a common source of avoidable rejection. Treating FSC preparation as a critical path activity — not a document to be assembled at the end of dossier preparation — is a simple operational adjustment with disproportionate impact on submission success rate.

6.6 Monitor Brazil's Evolving Tax Reform Context

Brazil is in the midst of a major tax reform, with two new taxes (CBS and IBS) introduced in a testing phase from January 2026, expected to coexist with the old system through approximately 2032. Manufacturers building long-term Brazilian market access strategies should incorporate tax advisory support — alongside regulatory advisory — to understand the cost structure implications of the reform on importation, distribution, and pricing models for medical devices within the Sistema Único de Saúde (SUS) and private hospital channels.

7. Conclusion

Brazil, Mexico, and Costa Rica each present distinct regulatory architectures that reflect their broader economic positioning, institutional maturity, and engagement with international harmonisation frameworks. Brazil's ANVISA system is the most comprehensive and independent, rewarding manufacturers who invest in MDSAP and treat the market with the full rigour of a major jurisdiction. Mexico's COFEPRIS has undergone transformative reform, and the September 2025 Equivalency Route has made it one of the most accessible markets in Latin America for internationally approved devices. Costa Rica, though smaller in scale, offers a sophisticated digital infrastructure through Registrelo and a practical alignment with US FDA and Health Canada frameworks that makes it an accessible and strategically valuable entry point for the Central American subregion.

Across all three markets, the most consistent themes are the universal value of international approvals (particularly FDA and CE marking) in reducing registration burden, the structural risks of distributor-controlled licences, and the growing role of digital platforms in shaping regulatory workflows. As the region continues to develop its regulatory infrastructure — with ANVISA deepening UDI implementation, COFEPRIS expanding its equivalency framework, and Costa Rica advancing toward higher WHO maturity ratings — the Latin American regulatory landscape will continue to reward manufacturers who engage early, plan rigorously, and build durable local regulatory relationships.