Cleanroom contractor in Mexico: cuartos limpios and salas limpias

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your facility

NOM-059-SSA1-2015 was published in the DOF on 5 February 2016 and is listed as in force (PLATIICA, checked 31 October 2026). COFEPRIS has been a PIC/S participating authority since January 2018 (PIC/S, checked 31 October 2026).

NOM-241-SSA1-2025 was published on 4 April 2025 and takes effect 240 calendar days later, which is 30 November 2025. It replaces NOM-241-SSA1-2021. It requires production areas to be classified under its Appendix A, and its references list ISO 14644 parts 1 to 5 (DOF, 4 April 2025).

NOM-016-SSA3-2012 asks for operating rooms with filtered air and no recirculation, and recommends 20 to 25 air changes per hour. It sets no particle counts (DOF, checked 31 October 2026).

Who builds cleanrooms here

Medicine factories, medical device factories and hospitals are the regulated buyers. Each has its own NOM, so the room list should name the rule that applies.

Import duties from 2026

A decree published on 29 December 2025 sets new import duties on about 1,463 tariff lines, mainly steel, aluminium, plastics, textiles and auto parts, from 5% to 50%. It took effect on 1 January 2026 (Galicia Abogados, 29 December 2025).

It does not apply to goods from a country with a free-trade agreement with Mexico, if origin rules are met. China has no such agreement with Mexico, so budget as if the decree applies. Check the tariff code and origin of each panel, door and air item with your customs broker.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether NOM-059 or NOM-241 applies, or whether the rooms are in a hospital.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• How long does it take to build a cleanroom?
• How to audit a cleanroom panel factory, on site or by video
• Cleanroom cost per m²: published ranges by ISO class
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• PLATIICA, NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos (DOF 5 February 2016; checked 31 October 2026)
• DOF, NOM-241-SSA1-2025, Buenas prácticas de fabricación de dispositivos médicos (4 April 2025)
• DOF, NOM-016-SSA3-2012, características mínimas de infraestructura y equipamiento de hospitales (checked 31 October 2026)
• PIC/S, list of participating authorities (COFEPRIS, PIC/S Scheme from January 2018; checked 31 October 2026)
• Galicia Abogados, Reforma a la Tarifa de la Ley de los Impuestos Generales de Importación y de Exportación (29 December 2025)