Mandatory NAT alongside existing viral screening
Mexico published NOM-253-SSA1-2025, its updated standard for human blood and blood components for therapeutic use, on 12 October 2026. The Secretariat of Health standard establishes requirements for blood-service establishments. Its most direct relevance to the device sector is donor-screening assays, immunohaematology reagents and the systems used to perform those tests.
Section 10.4.17 requires blood banks, biological testing centres and blood processing centres to perform nucleic acid amplification testing (NAT) for HIV, hepatitis B virus and hepatitis C virus. It permits transcription-mediated amplification, polymerase chain reaction or equivalent techniques.
This changes the approach in section 9.4.13 of NOM-253-SSA1-2012, which set conditions for blood banks that performed NAT. The new text expressly requires the testing. Section 10.4.18 retains an important limitation: the donor-screening NAT required here neither replaces the other viral screening tests required by the chapter nor serves as confirmatory testing. Laboratories therefore need to assess NAT within their complete testing strategy.
Section 10.4.2.2 also specifies DNA and RNA testing on individual donor samples. Samples must be collected according to the test manufacturer’s instructions to minimise degradation of the genetic material being measured. Sample-processing arrangements are consequently a specific point to examine when assessing an existing platform against the new text.
Irregular antibody screening extends to all donors
Under section 9.5.5.1 of the 2012 standard, screening for clinically significant irregular antibodies, with identification where appropriate, applied to donors and recipients with a history conducive to alloimmunisation. Sections 10.5.1.2 and 10.5.5.1 of the new standard expressly require screening of all donors. A positive donor screen requires antibody identification; plasma from a donor with irregular antibodies must be handled under the standard’s final-disposition provisions.
The reagent requirements are also relevant to immunohaematology suppliers. Section 10.5.5.1 specifies screening red-cell panels designed to detect clinically significant antibodies in the target population or a similar population. Section 10.5.5.2 permits pooled red cells designed and validated by the manufacturer for this use. The product’s intended use and evidence supporting population coverage therefore warrant closer attention than a general claim that it can perform antibody screening.
Two successive 180-day periods
Chapter 25 and the first transitional provision specify entry into force 180 calendar days after publication. The second transitional provision withdraws the 2012 standard when the new standard takes effect. The third gives blood services a further 180 calendar days after entry into force to comply with NAT and irregular antibody screening requirements.
The 12 October 2026 date is the publication date. The new standard had not entered into force when this article was published. The additional implementation period applies to the two specified testing requirements and should not be treated as a blanket extension for the whole standard.
Suppliers assessing products for local blood-service customers can also refer to section 10.1.2. Reagents must be validated by the manufacturer for use in blood donors, verified by the blood service, carry a Secretariat of Health sanitary registration number and be within their expiry date. Section 9.1(b) of the 2012 standard already required validated reagents with a sanitary registration number, so the registration-number requirement should not be presented as a new obligation.
For affected IVD suppliers, the practical assessment is whether the product and supporting evidence accommodate individual-donor testing, the relevant antibody-screening population and the customer’s verification work within the applicable transition period. These blood-service requirements do not establish a general reform of device registration or justify a conclusion that every existing IVD requires re-registration.
Sources
- Primary official sourceNORMA Oficial Mexicana NOM-253-SSA1-2025, Para la disposición de sangre humana y sus componentes con fines terapéuticos. (opens in a new tab)Secretariat of Health
- Supporting sourceNORMA Oficial Mexicana NOM-253-SSA1-2012, Para la disposición de sangre humana y sus componentes con fines terapéuticos. (opens in a new tab)Secretariat of Health
- Supporting sourceNormas Oficiales (opens in a new tab)Diario Oficial de la Federación