  
  
G/TBT/N/MEX/530  
14 May 2024 
(24-3741) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : MEXICO  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Secretaría de Salud  (Ministry of Health)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Secreta ría de Salud, through the Comisión Federal para la Protección contra Riesgos 
Sanitarios  (Federal Commission for Protection against Health Risks)  
Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario  (National 
Advisory Committee on S tandardization for the Regulation and Promotion of Health), 
located at Oklahoma número 14, planta baja, colonia Nápoles, código postal 03810, 
demarcación territorial Benito Juárez, Ciudad de México, Tel. : 5550805200, Ext. 11333, 
Email: rfs@cofepris.gob.mx  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
notified draft Mexican Official Standard is mandatory throughout Mexican territory for 
establishments involved in the manufacture, pac kaging, distribution and import of medical 
devices to be marketed or supplied in Mexico.  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Norma Oficial Mexicana PROY -NOM-137-SSA1 -2024, Etiquetado de dispositivos médicos 
(draft Mexican Official Standard PROY -NOM-137-SSA1 -2024 on the labelling of medical 
devices) (24 pages, in Spanish)  G/TBT/N/MEX/530  
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  6. Description of content:  
• Purpose  
The notified draft Mexican Official Standard establishes the requirements governing the 
health information that must be contained in the labelling of medical devices for human 
use that are intended for users in, and are to be marketed and made available throughout, 
Mexican territory, for the correct use and traceability of the devices.  
• Scope  
The not ified draft Mexican Official Standard is mandatory throughout Mexican territory for 
establishments involved in the manufacture, packaging, distribution and import of medical 
devices to be marketed or supplied in Mexico.  
Medical devices are crucial for the prevention, diagnosis and treatment of illnesses, as 
well as for patient rehabilitation . The notified draft Mexican Official Standard PROY -NOM-
137-SSA1 -2024 stipulates that medical devices must include visible labelling containing 
health information relati ng to the identification of the medical device, the identity of the 
manufacturer, the technical description, the intended purpose, the correct use or intended 
use, how the device must be maintained and stored, and any residual risk, warning, 
limitation or contraindication required to support and assist users of the medical device, 
to ensure its safe and appropriate use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling ; Prevention of decep tive practices and 
consumer protection ; Protection of human health or safety  
8. Relevant documents:  
The following existing standards, or those replacing them, should be consulted in order 
to correctly implement the notified draft Mexican Official Standard : 
• Mexican Official Standard NOM -008-SCFI-2002, Sistema General de Unidades de 
Medida . 
• Mexican Official Standard NOM -050-SCFI-2004,  Información comercial - 
Etiquetado general de productos . 
• Mexican Official Standard NOM -072-SSA1 -2012, Etiquetado de medicamentos y 
de remedios herbolarios . 
• Mexican Official Standard NOM -240-SSA1 -2012, Instalación y operación de la 
tecnovigilancia . 
• Mexican Official Standard NOM -241-SSA1 -2021, Buenas prácticas de fabricación 
de dispositivos medicos . 
• Pharmacopoeia of the U nited States of Mexico, Suplemento para dispositivos 
médicos  5.0. 
• Pharmacopoeia of the United States of Mexico, Suplemento para Establecimientos 
dedicados a la venta y suministro de medicamentos y demás Insumos para la 
Salud  (Sixth edition) . 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 60 days from notification  G/TBT/N/MEX/530  
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  11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Servicio nacional de información  (National Enquiry Point)  
Secretaría de Economía  (Ministry of the Economy)  
Dirección General de Normas  (General Directorate of Standards)  
Julio Eloy Páez Ramírez  
Director General de Normas  (Director -General of Standards)  
Pachuca 189, Colonia Condesa, Cuauhtémoc, 06140 Ciudad de México  
Tel.: (+52 55) 5729 9100 (Ext. 13202)  
Email: julio.paez@economia.gob.mx ; Cc: dgn.industriabasica@economia.gob.mx  
Authority resp onsible for the measure:  
Secretaría de Salud, through the Comisión Federal para la Protección contra Riesgos 
Sanitarios.  
Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario, located 
at Oklahoma número 14, planta baja, colonia Nápoles, código postal 03810, demarcación 
territorial Benito Juárez, Ciudad de México, Tel. : 5550805200, Ext. 11333, Email: 
rfs@cofepris.gob.mx  
https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.ta
b=0 
https://members.wto.org/crnattachments/2024/TBT/MEX/24_03198_00_s.pdf  
 