Reform of the General Health Law 2026: Modernization and strategic challenges for the Mexican health sector
The reform to the General Health Law published in the Official Gazette of the Federation (DOF) on January 15, 2026, marks a milestone in Mexican sanitary regulation. This update not only formalizes Digital Health and Telehealth but also strengthens post-market surveillance mechanisms and restructures the validity period of Sanitary Registrations. For manufacturers and distributors, this represents a mandatory transition toward more dynamic technical compliance models and an opportunity to bolster national production under new state incentives.
Update
The Federal Executive has enacted profound changes aimed at aligning Mexican regulations with international standards for digital health and risk control. Furthermore, the reform highlights the creation of a robust framework for mandatory Technovigilance and a strategic adjustment to the duration of sanitary authorizations.
Regulatory Framework
The following section details some of the amendments to the General Health Law:
Digital Health (Arts. 71 Bis to 71 Octies): Establishes rules for the use of algorithms and platforms in health services.
Sanitary Registrations (Art. 376): Initial 5-year validity. Subsequent renewals for 10-year periods (subject to compliance).
Post-market Surveillance (Art 262 Bis): Post-market surveillance of medical devices shifts from a recommendation to a strict legal mandate.
National Production (Art. 10): Preference for domestic investment in consolidated procurement processes.
Sanitary Control (Art. 194): Explicitly includes dietary supplements under the sanitary control regime for processing, import, and export.
Effects from RAUpdate
For the industry, these changes are not merely administrative, but operational:
Post-Market Surveillance reengineering: Medical device manufacturers can no longer view post-market surveillance as a reactive annual report. Art. 262 Bis mandates an active risk management system. Companies must integrate technical departments capable of reporting adverse events in real-time to maintain the validity of their Sanitary Registration.
Adaptation of Software as a Medical Device (SaMD): With the new articles on Digital Health, diagnostic apps and telemedicine platforms formally fall under COFEPRIS scrutiny. Companies must validate that their technological developments comply with personal data protection and clinical safety standards required by the new Law.
Regulatory Planning: The adjustment to Art. 376 forces Regulatory Affairs departments into long-term planning. A renewal denied at the 5-year mark due to a lack of technical evidence in surveillance will result in immediate removal from the national market.
Local Investment: A competitive advantage is granted to manufacturers established within national territory. This incentivizes both domestic and foreign manufacturers to establish a physical manufacturing or research presence in Mexico to remain competitive in consolidated public tenders.
Strictness in Dietary Supplements: The reform to Article 194 consolidates sanitary control over dietary supplements, granting COFEPRIS explicit powers for sampling, verification, and the enforcement of safety measures across all stages: processing, import, and export.
Written By:
Israel Jiménez
About IPS
Our Regulatory Affairs team helps medical device manufacturers obtain sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.