The inaugural edition of LATAM Regulatory Dispatch maps the Q1 2026 regulatory shifts shaping medical device market access across Mexico, Brazil, Chile, Argentina, and Colombia. Covering COFEPRIS's abbreviated regulatory pathway and 10-year device registration renewals, ANVISA's AREE reliance framework, Chile's ISP decree expansions, Argentina's digital platforms (Helena and Themis), and Colombia's INVIMA contingency plan.
Mexico · Brazil · Chile · Argentina · Colombia
Welcome to the inaugural edition of LATAM Regulatory Dispatch, your weekly guide to medical device regulations and market access across Latin America.
If you are a MedTech company looking to enter or expand in Latin America, this first edition covers the most impactful regulatory developments from Q1 2026 across Mexico, Brazil, Chile, Argentina, and Colombia.
Mexico kicked off 2026 with a major reform to the General Health Law, published on January 15. The key change: medical device registration renewals can now be granted for up to 10 years, up from the previous 5-year cycle. Initial registrations remain at 5 years, but subsequent renewals under the updated Article 376 give manufacturers a longer compliance runway. This reduces renewal frequency but demands stronger lifecycle management, as COFEPRIS can cancel registrations for unauthorized changes or missed renewal deadlines.
Additionally, COFEPRIS continues to expand its reliance framework for reference regulatory authorities, creating a faster pathway for devices already approved by agencies like the FDA, EU MDR notified bodies, and Health Canada. Standard review timelines for lower-risk categories have been compressed from 30 to 20 business days following simplification measures published in March 2025.
ANVISA published Normative Instruction No. 426/2026 on February 18, establishing the requirements for Brazil's Unique Device Identification (UDI) database. The regulation took effect on March 1, 2026, and non-compliance now constitutes a sanitary infraction. Class III devices had a compliance deadline of January 10, 2026, with Class II devices due by 2027 and Class I by 2028. Manufacturers shipping devices to Brazil must closely monitor the ANVISA UDI database as it will significantly impact the market throughout 2026.
ANVISA also approved its Regulatory Agenda for 2026-2027, covering 161 topics including 14 specific to medical devices. Key priorities include updating the framework for Software as a Medical Device (SaMD), with new expectations around cybersecurity, AI-driven software, and lifecycle controls. The agency is also reviewing its approach to reprocessing of medical devices and combination products.
On March 19, 2026, Chile published Exempt Decree No. 25 from the Ministry of Health, incorporating 39 medical devices and in vitro diagnostics into the mandatory health control regime. This includes diagnostic equipment, clinical monitoring equipment, treatment equipment, and medical software. The Institute of Public Health (ISP) will now verify conformity for these device categories, with compliance deadlines of 24 and 36 months depending on device type. Chile is also advancing a legislative proposal to modernize the Sanitary Code Act, which would grant ISP broader authority over medical device regulation.
Argentina's ANMAT reduced the minimum shelf-life requirement for imported medical devices from 12 months to 6 months under Disposition 2565/2025, responding to industry requests to ease market access for innovative products. The country also ran a Medical Device Regulatory Reliance Programme between September 2025 and February 2026, allowing certain devices already approved by trusted international authorities to follow a streamlined pathway. ANMAT continues to process registrations through the HELENA digital system, with review timelines of 15-30 business days for Class I/II and 60-110 days for Class III/IV devices.
Colombia's INVIMA presented at the IMDRF Stakeholder Forum on March 10, 2026, showcasing its evolving regulatory framework for medical devices, including provisions for personalized devices and a risk-based approach aligned with international standards. INVIMA continues to enforce Decree 4725/2005 for medical devices and Decree 3770/2004 for IVDs, using a four-class risk system similar to the EU MDR. The agency is increasingly aligning with ISO 13485 requirements and expanding UDI adoption.
The trend across LATAM is clear: regulatory agencies are modernizing, adopting international harmonization frameworks, and tightening post-market surveillance. For MedTech companies, the opportunities are significant but demand proactive planning:
At bioaccess®, we help MedTech companies navigate the regulatory landscape across Latin America. If you need guidance on registration strategy, market access, or regulatory compliance in any of these markets, reach out to us at bioaccessla.com.
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