Amendment to the General Health Law: What are the changes and how is the health sector in Mexico redefined?

On January 15, 2026, the Federal Executive published the Decree amending, adding to, and repealing various provisions of the General Health Law (hereinafter, the “Amendment”), addressing matters such as digital health, sanitary regulation, infrastructure, medical devices, pharmacovigilance and technovigilance, electronic cigarettes and vaping devices, public procurement, among other issues of significant relevance to the sector.

The Amendment does not arise abruptly; rather, it is the result of a legislative process driven by accumulated pressure and structural deficiencies within the health system (e.g., infrastructure backlogs, fragmented digitalization, challenges in public procurement of health supplies, etc.), as well as by the active participation of the private sector, which in recent years has contributed technical input, policy positions, and operational experience in areas such as digital health, sanitary regulation, medical devices, pharmacovigilance, and infrastructure investment.

A. GENERAL CHANGES

In general terms, the Amendment introduces four relevant changes to Mexico’s health regulatory framework and, above all, to public policy, with immediate and medium-term impact on the health sector:

1. Incorporation of digital health as a matter of general public health.- Digital health is expressly defined and regulated within the Mexican legal framework, creating a specific chapter with concrete purposes and obligations that provide greater legal certainty for health services adapted to current realities and the use of health technologies (e.g., telemedicine, electronic prescriptions, telehealth, wearable devices, etc.).
2. National Master Plan for Health Infrastructure and High-Technology Medical Equipment (Master Plan).- A new scheme for planning and control of public infrastructure in the sector is formalized, requiring that any project involving the creation, replacement, or expansion of infrastructure and technology in the health sector be registered under this Master Plan, thereby allowing the alignment of needs and resources.
3. Sanitary Regulation.- Relevant changes are consolidated with respect to sanitary regulation and market access, including matters related to the validity of marketing authorizations, the prohibition on the use of authorized third parties for good manufacturing practices certification procedures, new controlled substances, pharmacovigilance, technovigilance, sanitary control, and the express prohibition on the commercialization of electronic cigarettes/vaping devices, with immediate effects.
4. Strengthening of the National Medical Arbitration Commission.- CONAMED is consolidated as a decentralized administrative body with full technical and operational autonomy to intervene in conciliation, mediation, and arbitration proceedings for the resolution of disputes between users and providers of health services. Health institutions throughout the country are afforded the possibility to enter into agreements recognizing CONAMED’s jurisdiction to conduct proceedings and issue determinations as an alternative dispute resolution mechanism.

B. PRACTICAL IMPACTS FOR THE INDUSTRY

The Amendment introduces significant structural and public policy changes for the health sector in Mexico, which may translate into impacts or opportunities that sector participants will need to assess and consider, including the following:

1. The standard for interoperability, cybersecurity, and data governance in the context of digital health is modified. This is the case even though secondary legislation remains pending, and may accelerate digitalization projects in both public and private institutions.
2. A certain degree of order or vertical structure (Federation, States, Municipalities) is introduced for public infrastructure projects, which may lead to a reconfiguration of development strategies for hospital infrastructure projects, high-technology medical equipment, and the financing of such projects.
3. CONAMED is strengthened as an entity to hear and resolve disputes within the sector. The strategic relevance of clinical dispute prevention models, complaint management, and patient safety and quality programs is increased.
4. For companies linked to the retail, nicotine, e-commerce, logistics, and marketplace sectors, the primary focus will be on risk containment and, in some cases, portfolio redesign.

The amendment to the General Health Law marks a turning point for the health industry in Mexico across multiple areas. Beyond regulatory adjustments, the Amendment redefines how medical services will be provided, how infrastructure will be planned, how regulatory risks will be managed, and how access to the public and private markets will be structured in the coming years. The challenge for companies doing business in Mexico will not merely be compliance with the new requirements, but rather anticipating their impact, adjusting business models, and capitalizing on the opportunities that the new legal framework offers to sector participants.

At Cuesta Campos, we have extensive experience advising national and multinational companies on regulatory-sanitary and compliance matters in the health sector, and we remain at your disposal should you have any questions or comments regarding the scope or effects of the Amendment.

Contact

Héctor Mercado

hmercado@cuestacampos.com

THE ABOVE IS PROVIDED AS GENERAL INFORMATION PREPARED BY PROFESSIONALS WITH REGARD TO THE SUBJECT MATTER. THIS DOCUMENT ONLY REFERS TO THE APPLICABLE LAW IN MEXICO. WHILE EVERY EFFORT HAS BEEN MADE TO ENSURE ACCURACY, NO RESPONSIBILITY CAN BE ACCEPTED FOR ERRORS OR OMISSIONS. THE INFORMATION CONTAINED HEREIN SHOULD NOT BE RELIED ON AS LEGAL, ACCOUNTING OR PROFESSIONAL ADVICE BEING RENDERED.