On 15 January 2026, Mexico reached a new milestone in its health care modernization efforts with the publication of a Decree amending, adding, and repealing several provisions of the General Health Law in the Federal Official Gazette (the "Amendment"). This reform underscores the nation's long-term commitment to advancing digital health and strengthening the regulatory foundations that support innovation while protecting patient safety and privacy.

Mexico's health care technology sector is undergoing rapid transformation, and the legal framework is evolving to meet the needs of a digital era. The 2026 Amendment builds on years of regulatory progress. A key milestone in this evolution was the 2021 update to NOM 241 SSA1 2012, which governs Good Manufacturing Practices for medical devices. That revision formally recognized software as a medical device for the first time, establishing how digital tools intended for diagnostics, therapy, or monitoring should be regulated. This step paved the way for clearer oversight of technologically driven health care solutions.

Further momentum came in May 2023 with the publication of Supplement 5.0 of the United Mexican States Pharmacopoeia for Medical Devices. This supplement introduced a structured framework for classifying medical software by risk level, offering much needed clarity for developers, manufacturers, and investors navigating the regulatory landscape.

The 2026 Amendment significantly expands these foundations by expressly regulating digital health within the national health care system. It provides legal definitions for digital health applications, including telemedicine, telehealth, mobile health tools, wearable technologies, and electronic medical records. Public institutions must now assess their technological capabilities, train personnel, ensure interoperability across digital platforms, and promote digital inclusion. The Amendment also requires that telehealth services be delivered by trained professionals through secure systems that guarantee confidentiality and data protection. Informed consent procedures and detailed digital documentation are now mandatory components of remote care.

The overarching aim of the reform is to modernize the National Health System by enhancing equity, accessibility, and efficiency. Digital health is envisioned as a mechanism to expand care in underserved regions, optimize the use of human and technological resources, and employ data intelligence to improve diagnoses, treatment personalization, and system wide decision making.

To operate under this new model, institutions must comply with rigorous requirements, including the use of reliable platforms that ensure the integrity and confidentiality of patient information. Meanwhile, the Ministry of Health is tasked with issuing implementation guidelines, security protocols, medical care standards, and continuous training programs.

Complementing these efforts, COFEPRIS is modernizing its own regulatory processes through electronic platforms that streamline approvals, documentation, and oversight. Together, these initiatives position Mexico as a leader in digital health, fostering innovation while maintaining robust patient protections.