Today, January 15th, 2026, the Decree amending, adding, and repealing several provisions of the General Health Law (the “Amendment”) was published in the Federal Official Gazette.
The Amendment will have repercussions in different areas, including the following:
1. Digital Health
The Amendment includes the regulation of telemedicine, telehealth, mobile health, electronic medical or health records, and wearable devices.
2. Good Manufacturing Practices (“GMP”) for Medicines
Under the published Amendment, the possibility of having inspections conducted by authorized third parties for the issuance of GMP Certificates is eliminated.
III. Marketing Authorizations for Medical Devices
Regarding the granting of marketing authorizations for medical devices, once the authorization has been granted, technovigilance must be carried out (this obligation is included in the law, previously only at NOMs).
1. Electronic cigarettes, vapes, and other analogous systems or devices
The Amendment provides the definition of electronic cigarettes and empowers the health authority to carry out inspections, apply safety measures, and implement the sanitary disposition of vapes.
The acquisition for purposes of commercialization, preparation, production, manufacturing, mixing, processing, packaging, transportation for commercial purposes, storage, importation, exportation, trade, distribution, sale, and supply of electronic cigarettes and other analogous devices is prohibited.
A penalty of one to eight years of imprisonment is established for anyone who, by any means, engages in any of the conducts described above, as well as a fine of up to $234,620.00 MXN.
Any health authorizations related to electronic cigarettes or analogous devices granted prior to the effective date of the Amendment shall automatically become null and void.
The Amendment will come into force on January 16, 2026.
Should you have any questions, comments, or require any clarification regarding the foregoing information, please do not hesitate to contact our senior counsel:
Tel: (52-55) 4748-0600
Guillermo Govela