On April 8th, 2026, the Draft Official Mexican Standard (“NOM”) PROY-NOM-263-SSA1-2026, regarding Good Practices for the Operation of Corneal Tissue Banks for Transplantation Purposes, was published in the Official Gazette of the Federation (“DOF”).
The draft NOM establishes the sanitary, technical, and operational requirements for the operation of corneal tissue banks, including aspects such as: i) procurement, evaluation, preservation, and storage of corneal tissue; ii) processing and distribution of tissues intended for ophthalmic transplantation; iii) infrastructure, personnel, and sanitary control requirements applicable to tissue banks; iv) traceability, quality control, and documentation procedures; and v) guidelines to ensure the safety and viability of corneal tissue intended for clinical use.
The proposed standard seeks to strengthen sanitary safety and standardize practices related to the procurement and handling of corneal tissues used in transplant procedures.
The draft NOM is currently open for public consultation, and interested parties may submit comments to the competent authority within 60 calendar days from its publication in the DOF.
Although the NOM is primarily addressed to tissue banks and healthcare establishments, it may have implications for companies in sectors such as the ophthalmic industry that collaborate with transplant programs or tissue banks.
