Conformity assessment and NOM certification route?

Plan for Mexican conformity assessment via NYCE/ANCE and an RFC-registered importer; do not assume GB certificates transfer.

Spanish-language labelling, instructions and importer information?

Produce a Spanish label with importer RFC, NOM class and use instructions before import; Chinese-only labels will not clear PROFECO.

Product marking, class designation and NOM mark?

Add the NOM mark, certificate reference and NMX-aligned class to the product; GB/NMPA marks alone are insufficient for Mexico.

Filtration efficiency and breathing resistance performance?

Map GB KN/KP results to the NMX class and confirm breathing-resistance evidence under the Mexican method before claiming a Mexican class.

Total inward leakage, fit and harmful-substance / biocompatibility safety?

Provide leakage/fit and biocompatibility evidence mapped to NMX and COFEPRIS formats; do not rely on GB panel data alone for the Mexican selection duty.

Product scope and regulatory framework classification?

Determine occupational vs medical use first; the use category, not the GB class, decides the Mexican regulatory path.

Respirator Compliance: China to Mexico (NOM) Cross-Standard Guide

Name: Respirator Compliance: China to Mexico (NOM) Cross-Standard Guide
Creator: Cross-Standard
License: https://creativecommons.org/licenses/by/4.0/

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item	Common China baseline	Mexico (NOM)	Gap / action	Source + verification date
Conformity assessment and NOM certification route	In China, filtering respirators are type-tested and certified to GB 2626 (self-priming filtering respirators) or GB 19083 (medical protective masks). Special labour-protection products historically required the LA mark; current practice relies on manufacturer testing to the GB standard and registration with relevant authorities, plus medical device registration through NMPA for medical masks.GB 2626-2019 GB 19083-2010 / GB 19083-2024 NMPA medical device registration (medical masks)	Respirators placed on the Mexican market must undergo conformity assessment against the applicable Norma Oficial Mexicana (NOM). Mandatory NOMs require certification by an accredited certification body such as NYCE or ANCE, with testing in an accredited laboratory and a valid in-country importer holding an RFC tax registration. Occupational respiratory protection is governed by STPS, while medical masks fall under COFEPRIS.Ley Federal sobre Metrología y Normalización / Ley de Infraestructura de la Calidad NOM-116-STPS-2009 (occupational respiratory protection) Conformity assessment via accredited bodies NYCE / ANCE	Chinese GB type-test reports are not automatically recognised in Mexico. The exporter must re-run or map testing to the applicable NOM/NMX, engage an accredited Mexican body (NYCE/ANCE), and route certification through an importer with a valid RFC. Medical masks add a separate COFEPRIS pathway.[INFORMATIONAL] Plan for Mexican conformity assessment via NYCE/ANCE and an RFC-registered importer; do not assume GB certificates transfer.	Secretaría del Trabajo y Previsión Social (STPS), Mexico2026-06-15 · reference
Spanish-language labelling, instructions and importer information	Under GB 2626 and GB 19083 the package/instructions must state the standard, class, manufacturer, model, usage and storage conditions and shelf life, typically in Chinese for the domestic market. Medical masks follow NMPA labelling and instruction-for-use rules. There is no requirement for Spanish or for a Mexican importer/RFC on the Chinese-market label.GB 2626-2019 (packaging/instructions) GB 19083-2010 / GB 19083-2024 NMPA labelling rules (medical masks)	Products sold in Mexico must carry commercial information in Spanish, including product description, protection class, instructions for use, storage and limitations, country of origin, and the name, address and RFC of the in-country importer/responsible party. Labelling must follow the applicable NOM on commercial information (NOM-024-SCFI style requirements) and, for occupational PPE, present selection and use guidance consistent with NOM-116-STPS. PROFECO enforces consumer commercial-information labelling.NOM-024-SCFI (commercial information labelling, Spanish) NOM-116-STPS-2009 (use instructions) Importer RFC / responsible-party identification	Chinese-market labels are in Chinese and carry no Mexican importer/RFC or Spanish instructions. For Mexico the exporter must add full Spanish commercial information, the importer name/address/RFC, NOM-aligned class and use guidance, and country of origin; PROFECO can detain or sanction non-compliant labelling at retail.[INFORMATIONAL] Produce a Spanish label with importer RFC, NOM class and use instructions before import; Chinese-only labels will not clear PROFECO.	Procuraduria Federal del Consumidor (PROFECO), Mexico2026-06-15 · reference
Product marking, class designation and NOM mark	GB 2626 requires the respirator to be marked with the GB standard number, filter class (e.g. KN95), manufacturer, model and applicable shelf life; reusable parts and filters carry distinct markings. GB 19083 medical masks are marked with the standard, level and manufacturer, and medical masks display the NMPA registration/record number rather than a NOM mark.GB 2626-2019 (marking clauses) GB 19083-2010 / GB 19083-2024 NMPA registration number (medical masks)	Respirators must be durably marked with the manufacturer/brand, model, filter class/protection level and applicable standard reference, in a form that survives normal use. Products certified to a mandatory NOM carry the official NOM conformity mark from the accredited body (NYCE/ANCE) together with the certificate reference; medical masks display COFEPRIS-relevant identification. Markings must be legible and consistent with the certified test class.NOM conformity mark rules (accredited body NYCE / ANCE) NOM-116-STPS-2009 (respirator identification) NMX respirator marking provisions	Chinese product carries GB class marks (KN95) and NMPA numbers, which are not the Mexican identifiers. For the Mexican market the respirator must additionally bear the NOM conformity mark with the NYCE/ANCE certificate reference and an NMX-aligned class designation; medical masks need COFEPRIS-relevant identification rather than NMPA.[INFORMATIONAL] Add the NOM mark, certificate reference and NMX-aligned class to the product; GB/NMPA marks alone are insufficient for Mexico.	Normalizacion y Certificacion NYCE, Mexico2026-06-15 · reference
Filtration efficiency and breathing resistance performance	GB 2626 sets particulate filtration efficiency classes — KN90 (>=90%), KN95 (>=95%), KN100 (>=99.97%) for non-oily particles and KP classes for oily particles — plus inhalation and exhalation resistance limits. GB 19083 sets >=95% (Level 1), >=99% (Level 2) and >=99.97% (Level 3) filtration for medical protective masks with synthetic blood penetration resistance.GB 2626-2019 GB 19083-2010 / GB 19083-2024	Respirators sold for workplace protection in Mexico must demonstrate adequate particle filtration efficiency and acceptable inhalation/exhalation resistance for the assigned class, evidenced by testing to the applicable NMX respirator standard and selected/used in line with STPS NOM-116-STPS. Filtering classes and minimum efficiencies follow the referenced NMX/recognised method (commonly aligned with N/R/P style filter classes).NOM-116-STPS-2009 NMX respirator standard (filtration efficiency / breathing resistance test methods)	GB KN/KP classes and the Mexican NMX classes use different test aerosols and pass/fail thresholds, so a GB KN95 result does not automatically equal a Mexican class designation. Exporters must map their GB data to the NMX class and may need additional testing of breathing resistance under the Mexican method.[INFORMATIONAL] Map GB KN/KP results to the NMX class and confirm breathing-resistance evidence under the Mexican method before claiming a Mexican class.	Secretaría del Trabajo y Previsión Social (STPS), Mexico2026-06-15 · reference
Total inward leakage, fit and harmful-substance / biocompatibility safety	GB 2626 specifies total inward leakage (TIL) limits and exhalation-valve, strap and dead-space requirements; it also addresses flammability and removable parts. GB 19083 adds surface moisture, microbial and skin-irritation considerations, and medical masks must meet GB/T 16886 (ISO 10993-equivalent) biocompatibility for skin-contact materials.GB 2626-2019 (total inward leakage) GB 19083-2010 / GB 19083-2024 GB/T 16886 (ISO 10993) biocompatibility	Beyond filter performance, Mexican occupational selection under NOM-116-STPS requires that the respirator achieve an adequate face seal (low total inward leakage) for the wearer and that materials in skin contact be safe. STPS expects fit-testing and proper selection by the employer; certification evidence should cover leakage, straps/harness integrity and absence of harmful substances. Medical masks additionally require biocompatibility under COFEPRIS health-product rules.NOM-116-STPS-2009 (selection, fit and use) NMX respirator standard (total inward leakage / harness) COFEPRIS biocompatibility expectations (medical masks)	China demonstrates TIL via panel testing to GB 2626; Mexico's NOM-116-STPS places ongoing fit-testing and selection duties on the employer and may require leakage/harness data referenced to its NMX method. Biocompatibility data prepared to GB/T 16886 generally maps to ISO 10993 but must be presented in the COFEPRIS dossier format for medical masks.[INFORMATIONAL] Provide leakage/fit and biocompatibility evidence mapped to NMX and COFEPRIS formats; do not rely on GB panel data alone for the Mexican selection duty.	Diario Oficial de la Federacion (DOF), Mexico2026-06-15 · reference
Product scope and regulatory framework classification	China scopes respirators by GB standard family. GB 2626 covers non-powered self-priming filtering respirators for particulates (classes KN90/KN95/KN100, KP series), while GB 19083 covers medical protective masks. Daily-use protective masks follow GB/T 32610, and child masks GB/T 38880. The applicable GB standard fixes the test regime and class designation.GB 2626-2019 GB 19083-2010 / GB 19083-2024 GB/T 32610-2016 (daily protective masks)	Mexico treats respirators according to use. Respirators used to protect workers fall under the occupational health and safety framework administered by STPS, with NOM-116-STPS setting selection and use requirements and NMX standards defining respirator test methods and classes. Medical-use respirators and surgical masks are health products regulated by COFEPRIS. The correct framework determines which body certifies the product and what evidence is needed.NOM-116-STPS-2009 NMX respirator test standards (filtration efficiency / breathing resistance) Ley General de Salud (COFEPRIS scope for medical masks)	China classifies by GB standard and class (KN/KP), whereas Mexico classifies by intended use (occupational vs medical), routing the product to STPS/NMX or COFEPRIS. Exporters must first determine the Mexican use category, then map their GB class to the corresponding NMX class and evidence set — a different axis from the Chinese scope.[INFORMATIONAL] Determine occupational vs medical use first; the use category, not the GB class, decides the Mexican regulatory path.	Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico2026-06-15 · reference

RELATED COMPARISONS

Related Compliance Matrices

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SOURCES

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Secretaría del Trabajo y Previsión Social (STPS), Mexico · accessed 2026-06-15 · reference · used in 2 rows
Procuraduria Federal del Consumidor (PROFECO), Mexico · accessed 2026-06-15 · reference · used in 1 rows
Normalizacion y Certificacion NYCE, Mexico · accessed 2026-06-15 · reference · used in 1 rows
Diario Oficial de la Federacion (DOF), Mexico · accessed 2026-06-15 · reference · used in 1 rows
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico · accessed 2026-06-15 · reference · used in 1 rows