On January 15, 2026, a decree was published in the Official Gazette of the Federation (Diario Oficial de la Federación – DOF) that significantly amends the General Health Law in matters of health regulation, digital health, health services infrastructure, among others.
Amended and/or added provisions:
Article 222:
Establishes that the verification of Good Manufacturing Practices (GMP) for medicines may be carried out exclusively by the Ministry of Health, eliminating the possibility for authorized third parties to perform such verifications.
In addition, the obligation to conduct pharmacovigilance activities is incorporated once a sanitary registration for medicines has been granted.
Article 262 Bis:
This new article is added to regulate technovigilance activities that must be carried out after obtaining the sanitary registration for medical devices.
Article 376:
The term for renewing sanitary registrations is extended from 5 to 10 years. It is important to note that the validity granted upon issuance of a new sanitary registration remains five years.
Additional Relevant Topics Integrated and Updated
Digital Health:
Establishes a regulatory framework for telehealth, telemedicine, and electronic medical records, including requirements related to security, confidentiality, and documentation of medical care.
Medical Arbitration:
Creates the National Medical Arbitration Commission, granting it technical and operational autonomy to resolve disputes between users and healthcare providers through alternative dispute resolution mechanisms.
Responsibilities:
Strengthens the powers and authority of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS).
Consolidated Procurement:
Promotes the participation of national companies that invest in the production chain of medicines, medical devices, and other health-related supplies.
Prohibitions:
Prohibits the acquisition, marketing, and distribution of electronic cigarettes and vaping devices, and nullifies previously granted authorizations.
Infrastructure:
Projects involving the creation, replacement, or expansion of medical units must be registered in the Master Plan, with a maximum validity of six years.
The present Decree entered into force on the day following its publication in the Official Gazette of the Federation.
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