The purpose of this Client Alert is to inform you that, on January 15th, 2026, a Decree amending, adding to and repealing various provisions of the General Health Law (the “Law”) was published in the Official Gazette of the Federation (the “Decree”). The Decree introduces broad, cross-cutting amendments to the legal framework governing the healthcare system in Mexico, incorporating changes related to health governance, sanitary control, planning, infrastructure, the use of digital technologies, and institutional oversight and dispute resolution mechanisms.
Among other matters, the Decree addresses: i) the consolidation of digital health and the use of information and communication technologies in healthcare services; ii) the strengthening of national health information and planning systems; iii) relevant adjustments to the sanitary control regime applicable to products and services; and iv) specific amendments to the legal framework governing the donation, handling and use of blood, blood products and stem cells, with a direct impact on hospitals, blood banks, stem cell banks and other healthcare providers.
In this context, this Client Alert analyzes the main amendments introduced by the Decree, with a particular focus on those related to blood donation, blood products and stem cells, as well as other relevant regulatory clarifications affecting stakeholders in the healthcare sector.
The key changes in these areas are summarized below.
Stem Cells
1.- Informed consent for placental and umbilical cord blood.
The Decree expressly incorporates Article 321 Bis, requiring that the donation of stem cells obtained from placental and umbilical cord blood must at all times be supported by a written informed consent granted by the pregnant woman, ensuring her free will, autonomy and confidentiality.
2.- Reinforced prohibition on commercialization.
The absolute prohibition on the commercialization of stem cells is reinforced and expressly aligned with the prohibition applicable to organs, tissues, blood and blood products. Donations must comply with the principles of altruism, non-profit purpose and confidentiality, and must be carried out strictly free of charge.
3.- Institutional obligations and specialized committees.
Healthcare facilities that perform transplantation, infusion or handling of stem cells must establish a Stem Cell Transplant Committee, which must hold ordinary quarterly meetings and report adverse events in accordance with the regulations issued by the Ministry of Health. Where adequate infrastructure is not available, facilities must enter into mandatory agreements with authorized stem cell banks.
4.- National Registry of Blood and Stem Cells.
The National Registry of Blood and Stem Cells, overseen by the National Blood Transfusion Center, is strengthened as a key mechanism for traceability, biovigilance and sanitary control, integrating detailed information on authorized facilities, committees, donation activities and available units.
Blood Donation
1.- Express guiding principles.
New Article 340 Bis expressly systematizes the guiding principles governing blood and blood product donation, establishing that donations must be voluntary, altruistic, non-discriminatory, recurrent and free of charge.
2.- Regulation of residual plasma.
The Decree introduces a specific legal framework for residual plasma, allowing its industrial processing for the production of hemoderivatives, subject to the guarantee of domestic supply and the corresponding sanitary authorizations. Specific rules on exportation and importation are also established.
3.- Hemovigilance and biovigilance.
Healthcare facilities that perform blood transfusions or therapeutic use of stem cells must implement hemovigilance systems and participate in the national biovigilance system, reporting relevant activities to the Ministry of Health.
Digital Health and Health Information Systems
The Decree incorporates and further develops the concept of “Digital Health”, regulating the relationship between information and communication technologies and the provision of healthcare services. This includes, among others, telehealth, telemedicine, mobile health (mHealth), electronic medical or health records, and wearable devices.
The purpose of the amendment is to facilitate the remote delivery of medical services, optimize human and technological resources, promote digital interconsultations among healthcare professionals, strengthen the digitalization of medical records and clinical files, and encourage the secure exchange of medical information, with the Ministry of Health being entrusted with the implementation, supervision and continuous improvement of Digital Health.
Additionally, the amendment strengthens the national health information systems, as well as the mechanisms for strategic planning related to healthcare infrastructure and high-technology medical equipment. The Decree also reinforces the role of the Comisión Nacional de Arbitraje Médico (CONAMED) as an institutional mechanism for addressing complaints and disputes arising from the provision of healthcare services.
In particular, the Decree promotes the use of electronic alternative dispute resolution mechanisms, including the online filing of complaints, remote conciliation and mediation proceedings, digital case tracking, and enhanced accessibility for users of healthcare services.
Other Relevant Regulatory Clarifications
In addition to the amendments specifically related to blood donation and stem cells, the Decree also introduces certain clarifications to Title Twelve of the Law, which governs the Sanitary Control of Products and Services, as well as their importation and exportation.
In this regard, the Law now expressly clarifies that sanitary control shall be exercised by the Ministry of Health, primarily through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), with the participation of producers, distributors and consumers, and in accordance with other applicable legal provisions.
Furthermore, the Decree specifies that, for purposes of granting a sanitary registration for medicinal products, the verification of compliance with Good Manufacturing Practices and of the medicinal product’s manufacturing process shall be carried out exclusively by the Ministry of Health, and that no authorized third parties or private entities may participate in such verification processes.
These clarifications reinforce the non-delegable nature of certain regulatory functions in the area of sanitary control, particularly with respect to medicinal products, and should be taken into account by industry participants when assessing their regulatory compliance strategies and planning.
Final Recommendations
In light of these amendments, hospitals, blood banks, stem cell banks and other healthcare providers are advised to:
1.- Review documentation and contracts.
Update all informed consent forms related to the donation of placental and umbilical cord blood stem cells. Conduct a comprehensive review of contracts, agreements, internal policies and informational materials to ensure that no language, structure or practice could be construed, directly or indirectly, as involving the commercialization of blood, blood products or stem cells.
2.- Strengthening of internal governance.
Verify the proper establishment, composition and operation of the Transfusion Medicine Committees and Stem Cell Transplant Committees, as applicable. This includes confirming compliance with quorum and meeting frequency requirements.
3.- Regulatory compliance and traceability.
Ensure the timely registration, updating and accuracy of information before the National Registry of Blood and Stem Cells. Additionally, implement and maintain effective hemovigilance and biovigilance systems.
4.- Operational and infrastructure assessment.
Identify any infrastructure or operational gaps and, where applicable, formalize mandatory agreements with duly authorized blood banks or stem cell banks. Assess the operational, regulatory and contractual impact of the new legal framework governing residual plasma.
5.- Personnel training and awareness.
Provide targeted and ongoing training programs for medical, technical and administrative personnel to ensure adequate understanding of the new legal standards, guiding principles and compliance obligations introduced by the amendments.
We remain at your disposal to further discuss any of the points above or to analyze the specific implications of this Decree for your operations in Mexico.
