Regulation in Mexico for Medical Electrical Equipment

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Medical electrical equipment (MEE) has their own requirements for safety and performance due to the nature of the electrical/electronic systems involved.  

In the case of Mexico, there are specific norms that may be applicable to MEEs in addition the sanitary requirements. Those norms are of special interest for new medical technologies involving Bluetooth, WiFi or similar wireless connection methods.

 

Products with Bluetooth and/or WiFi

 

NOM-121-SCT1-2009 is the Mexican Norm applicable for products using wireless communication standards such as Bluetooth or WiFi. Considering that many MEE’s nowadays include these kind of technologies, custom agents may require to comply with this official norm. It is worth mentioning, that this norm is also applicable to products using ZigBee.

 

Norms to meet according to the MEE tariff code

 

The ministry of Economy released the Agreement that specifies the rules that every product must comply based on its Tariff code. This document is constantly updated and specifies the norms that any product must follow. This is also applicable for certain medical devices. For example, the tariff code 9021.50.01 corresponding to cardiac stimulation devices, indicates the need of compliance with NOM-121-SCT1-2009.

 

The key point to consider is that this norm (NOM-121-SCT1-2009) is not required for every medical device using Bluetooth or WiFi but only those referred in this Agreement.

 

Conclusions

 

MEE’s are subject to sanitary regulatory requirements, and also to specific norms. Therefore, in order to import MEE’s to Mexico, some products may need to comply with additional norms depending on the characteristics of the product. For such purpose, it is important to assign a tariff code to the MEE and find the applicable norm.

 

If you have questions about how to handle your Medical Electrical Equipment in Mexico, feel free to contact us at contact@veraqueconsulting.com