WTO notification · TBT
MexicoUpdated: check whether it is now adopted or in force
Official title
Proyecto de Norma Oficial Mexicana PROY-NOM-241-SSA1-2024, Buenas prácticas de fabricación de dispositivos médicos (Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices) (78 pages, in Spanish)
Mexico issued an addendum on 20 November 2025 to the earlier TBT notification G/TBT/N/MEX/534. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 1 August 2024. The comment period closed on 30 September 2024.
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Published here:
Updated here:
All establishments involved in the manufacture of medical devices, warehouses for the packaging, storage and distribution of medical devices to be marketed or supplied in Mexico
The comment period closed on 30 September 2024. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/MEX/534/Add.4; it can take them up with Mexico.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/MEX/534/Add.4, 20 November 2025)
Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices
The notified interpretative standard for Mexican Official Standard NOM-241-SSA1-2025, Good manufacturing practices for medical devices, sets out the provisions that must be observed in the documents guaranteeing compliance with the good manufacturing practices for medical devices.__________
Purpose • The purpose of the notified draft Standard is to set forth the minimum requirements for the design, development, manufacture, warehousing and distribution processes for medical devices for human use, based on their level of risk, that are to be marketed and made available in Mexican territory, so as to ensure their consistent compliance with quality, safety and performance requirements for use by the end consumer or patient. • The notified regulation also establishes the quality management and quality risk management system and provides for the design and development of medical devices, specifications for facilities and equipment, manufacturing systems, the control of inputs and specifications for quality control laboratories, among other considerations for applying good manufacturing practices. G/TBT/N/MEX/534 - 2 - Scope • This Standard is binding in Mexican territory on all establishments engaged in the manufacture of medical devices and on warehouses that package, store and distribute medical devices to be marketed or supplied in Mexico.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/MEX/534/Add.4
Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices
The notified interpretative standard for Mexican Official Standard NOM-241-SSA1-2025, Good manufacturing practices for medical devices, sets out the provisions that must be observed in the documents guaranteeing compliance with the good manufacturing practices for medical devices.__________
AddendumG/TBT/N/MEX/534/Add.3
Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices.
The Agreement issuing guidelines for the submission of documents guaranteeing good manufacturing practices for drugs, medicines and medical devices to accompany applications for new health registrations, extensions thereof and modifications thereto aims to establish the criteria and requirements for compliance with good manufacturing practice certificates or equivalent documents for drugs, medicines and medical devices to accompany applications for new health registrations, extensions thereof and modifications thereto.Meanwhile, the Agreement issuing general guidelines for the application of the abbreviated regulatory procedure for granting health registrations for health products in which the requirements, tests and evaluation procedures issued by reference regulatory authorities and the World Health Organization's prequalification programme are recognized as equivalent aims to establish the provisions to be observed by the Federal Commission for Protection against Health Risks in recognizing the decisions of other reference regulatory authorities and the WHO Prequalification of Medicines Programme for the granting of health registration for health products in the national territory.__________
AddendumG/TBT/N/MEX/534/Add.2
Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices
Please be advised of the publication on 4 April 2025 of Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices, which will enter into force 240 calendar days after publication.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.
AddendumG/TBT/N/MEX/534/Add.1
Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices
Please be advised of the publication of the REPLY to the comments received on draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices, published on 26 July 2024.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.
Regular notificationG/TBT/N/MEX/534
Comment deadline: Closed on 30 September 2024
Proyecto de Norma Oficial Mexicana PROY-NOM-241-SSA1-2024, Buenas prácticas de fabricación de dispositivos médicos (Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices) (78 pages, in Spanish)
Purpose • The purpose of the notified draft Standard is to set forth the minimum requirements for the design, development, manufacture, warehousing and distribution processes for medical devices for human use, based on their level of risk, that are to be marketed and made available in Mexican territory, so as to ensure their consistent compliance with quality, safety and performance requirements for use by the end consumer or patient. • The notified regulation also establishes the quality management and quality risk management system and provides for the design and development of medical devices, specifications for facilities and equipment, manufacturing systems, the control of inputs and specifications for quality control laboratories, among other considerations for applying good manufacturing practices. G/TBT/N/MEX/534 - 2 - Scope • This Standard is binding in Mexican territory on all establishments engaged in the manufacture of medical devices and on warehouses that package, store and distribute medical devices to be marketed or supplied in Mexico.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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