On October 12, 2026, Mexican Official Standard NOM-253-SSA1-2025, On the Handling of Human Blood and Its Components for Therapeutic Purposes (hereinafter, “NOM 253”), was published in the Mexican Official Gazette. Its purpose is to establish the activities, criteria, strategies, and operational procedures applicable within the National Health System in this field. NOM 253 is mandatory for professional, technical, auxiliary, and administrative personnel working in public, social, and private establishments engaged in such activities throughout Mexico.
NOM 253 covers the different stages of the transfusion chain, from donor selection and blood collection to testing, processing, storage, supply, use, and final disposition. It also establishes provisions concerning the operation of blood services, quality management systems, traceability of blood units, and hemovigilance.
The issuance of this new Standard responds to the need to incorporate scientific and technological advances in this field, strengthen transfusion safety, and promote alignment with international standards. Regarding its effective date, NOM 253 will enter into force on April 10, 2027, that is, 180 calendar days after its publication, at which time NOM-253-SSA1-2012, published on October 26, 2012, will cease to have effect.
However, its transitory provisions establish an additional period of 180 calendar days following its entry into force for blood services to comply with the requirements concerning nucleic acid amplification testing and irregular antibody screening. Furthermore, applications relating to sanitary licenses submitted before NOM 253 enters into force will be processed in accordance with the provisions in effect at the time of their submission.
If you need additional information regarding the contents of this alert or if you need legal assistance, please contact:
Guillermo Solórzano Leiro – Partner
GUILLERMO.SOLORZANO@S-L.MX
Phone: +52 55 50620057
Luis López Linaldi – Partner
LUIS.LINALDI@S-L.MX
Phone: +52 55 50015409
Alan Osorio Aragón – Associate
ALAN.OSORIO@S-L.MX
Phone: +52 55 50620074