The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail
By Julio G. Martinez-Clark, CEO, bioaccess
For medical device manufacturers, the global cybersecurity landscape is usually defined by strict codified mandates: the FDA's Section 524B, the EU's MDR, and recently, Brazil's RDC 657/2022. Against this backdrop of rigorous enforcement, Mexico often appears as a welcome anomaly — a low-friction market where Software as a Medical Device (SaMD) is barely regulated and entry barriers are falling.
However, this regulatory silence is a commercial trap. While Mexico's health authority, COFEPRIS, has streamlined registration, a dangerous shadow regulation has emerged in the public procurement sector. Driven by a surge in ransomware attacks, buyers like the Mexican Institute of Social Security (IMSS) and the Institute for Social Security and Services for State Workers (ISSSTE) are imposing ad hoc stringent cybersecurity requirements in tenders that catch even the most compliant global manufacturers off guard.
The Regulatory Mirage: Access Has Never Been Easier
On paper, Mexico is currently one of the most accessible markets for medical devices in Latin America. Effective September 1, 2025, COFEPRIS introduced a new Abbreviated Regulatory Pathway, allowing manufacturers to leverage approvals from the FDA, Health Canada, and other IMDRF members to secure registration in as little as 30 days.¹
Furthermore, unlike Brazil's ANVISA, which enforced Resolution RDC 657/2022 to mandate specific cybersecurity architecture and documentation for SaMD, COFEPRIS still lacks a specific comprehensive regulation for medical software.² For a regulatory affairs director, this looks like an easy win: fast approval with minimal technical documentation required for the software components.
The Commercial Reality: The Shadow Regulator
The disconnect occurs when the device moves from registration to procurement. In the absence of federal guidance, Mexican public healthcare institutions — which purchase the vast majority of medical devices in the country — have been forced to become de facto regulators.
Following a wave of ransomware attacks targeting Latin American healthcare infrastructure in 2024 and 2025, hospital IT directors began inserting defensive clauses directly into tender technical annexes (Anexos Técnicos). These requirements often bear little resemblance to standard FDA or MDR documentation.³,⁴
For example, recent state-level tenders have required vendors to provide engineers with Certified Ethical Hacker credentials to validate the security of connected medical equipment.⁵ Other tenders have demanded specific perimeter security configurations and malware-free guarantees that go beyond standard manufacturer warranties.
This creates a scenario where a device can be legally cleared for sale by COFEPRIS in 30 days yet be disqualified from a multimillion-dollar tender because the manufacturer cannot produce an arbitrary IT certification requested by a hospital administrator.
The 2026 Shift: The Vacuum Is Closing
This era of fragmented shadow regulation is likely drawing to a close. In November 2024, the Mexican government created the Agency for Digital Transformation (Agencia de Transformación Digital), a body with the status of a Secretariat of State.⁶
This agency includes a General Directorate of Cybersecurity tasked with standardizing policies across government entities. It is highly probable that this agency will soon harmonize the disparate requirements currently found in public tenders, potentially codifying them into a new rigorous national standard that could rival Brazil's RDC 657/2022 in complexity.
To succeed in Mexico's current hybrid environment, manufacturers must bridge the gap between regulatory clearance and commercial viability. The most effective approach is to recognize that COFEPRIS approval is merely the first gate — procurement readiness requires a fundamentally different preparation strategy.
Don't Stop At COFEPRIS
Do not assume your regulatory dossier is sufficient for market access. Your commercial team needs a separate Defense File specifically for tenders. This file should be maintained independently of your regulatory submission and should be updated quarterly as tender requirements evolve.
The Defense File should include translated versions of all cybersecurity documentation, even if COFEPRIS doesn't require them. Hospital procurement committees increasingly operate in Spanish only, and technical materials presented solely in English create unnecessary friction during the evaluation phase.
Audit for Shadow Requirements
Review recent technical annexes from IMSS and ISSSTE tenders to identify recurring IT demands. If ethical hacker certifications or specific data encryption standards are trending, ensure your local distributors or service partners possess them.
Many manufacturers overlook the fact that tender requirements in Mexico often target the vendor ecosystem, not just the device manufacturer. A hospital procurement officer may demand that the local service technician demonstrate cybersecurity credentials, not the manufacturer's compliance officer in California. Build relationships with Mexican service partners who maintain current IT certifications and can provide rapid responses to tender-specific security questionnaires.
Localize Your SBOM
While the FDA requires a software bill of materials (SBOM), ensure this data is translated and formatted to answer the specific anxieties of a hospital IT director in Mexico City, not just a reviewer in Washington.⁷
Mexican hospital administrators are particularly sensitive to supply chain vulnerabilities following recent high-profile ransomware incidents in the region. Your SBOM should explicitly address components sourced from regions that have experienced cyber incidents and should clearly document your risk mitigation strategies. This contextualization transforms a compliance document into a competitive differentiator.
Engage Before the Tender Drops
The most sophisticated manufacturers are engaging with procurement officials during the tender drafting phase, not after publication. While Mexico's public procurement rules prohibit preferential treatment, they do permit technical consultations in which manufacturers can educate procurement committees on realistic security standards for medical devices.
These pre-tender consultations serve two purposes: they help shape requirements that are achievable rather than arbitrary, and they signal to procurement officials that your organization understands Mexico's security landscape and takes it seriously.
The Broader Context: Regional Divergence
Mexico's cybersecurity evolution reflects a broader trend across Latin America: regulatory divergence driven by local threat landscapes. Brazil's RDC 657/2022 emerged from concerns about data privacy under LGPD (Brazil's GDPR equivalent). Mexico's shadow regulations stem from ransomware incidents targeting public hospitals. Colombia's recent focus on cloud-based medical devices reflects concerns about cross-border data flows.²
Manufacturers that attempt to apply a single Latin America strategy to cybersecurity will find themselves unprepared for these country-specific dynamics. Each market requires its threat assessment, stakeholder engagement strategy, and documentation approach.
Looking Forward: Standardization On The Horizon
The creation of the Agency for Digital Transformation signals Mexico's intent to formalize what is currently informal. When standardization arrives, manufacturers that have already built Defense Files and established relationships with procurement committees will have a significant advantage over competitors scrambling to understand new requirements.
Additionally, the likelihood of regional harmonization through mechanisms like the Pacific Alliance (Chile, Colombia, Mexico, Peru) suggests that early investments in Mexican cybersecurity readiness may yield dividends across multiple Latin American markets.
Conclusion
Mexico remains a critical market, but the days of viewing it as a cybersecurity soft target are over. The liability has simply shifted from the regulator to the buyer, and manufacturers that fail to recognize this shift risk being locked out of the region's largest tenders.
The opportunity, however, is real. Manufacturers that proactively build Defense Files, engage with procurement stakeholders, and localize their cybersecurity documentation will not only succeed in Mexico, they will establish a competitive advantage across Latin America's increasingly security-conscious healthcare procurement landscape.
The question is not whether Mexico's cybersecurity requirements will formalize — they will. The question is whether your organization will be prepared when they do.
References
- Pure Global. (2025, August 6). Mexico's COFEPRIS 2025 Abbreviated Pathway for Medical Devices. https://pureglobal.com/blog/mexicos-cofepris-2025-abbreviated-pathway-for-medical-devices
- Mattos Filho. (2022, March 23). Anvisa approves new regulatory framework for Software as a Medical Device. https://www.mattosfilho.com.br/unico/anvisa-approves-new-regulatory-framework-for-software-as-a-medical-device/
- Fortinet. (2025). Ransomware Statistics 2025. https://www.fortinet.com/resources/cyberglossary/ransomware-statistics
- Health-ISAC. (2025). 2025 Annual Threat Report. https://h-isac.org/
- Gobierno de Jalisco. (2025, January). Licitación Pública Local LPL-004-2025 (Multifuncionales), Anexo 2. https://info.jalisco.gob.mx/
- Chambers and Partners. (2025). Digital Healthcare 2025: Mexico Trends and Developments. https://practiceguides.chambers.com/practice-guides/digital-health-2025/mexico
- U.S. Food and Drug Administration. (2023). Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions
About The Author:
Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).