Mexico medical device market 101

by | Dec 12, 2023 | IMed Consultancy, New Markets

New markets - Mexico

Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region.

Now, we’re looking into those territories once again to offer a more succinct look at some of the other potential access markets in those regions. We’re now at the third and final instalment of this series, focused on Mexico.

The medical device market in Mexico

While it may not typically appear on a list of leading emerging markets in recent years, Mexico is the second largest medical device market and leading importer in the Latin America region.

Medical devices imported or distributed within Mexico must first be registered with the Ministry of Health (COFEPRIS). Medical devices are grouped according to their purpose such as dental supplies, medical equipment, surgical and Software (SaMD), which was just recently added. There are four risk classes (Low risk class and Class I to III). The classification of your device should be determined according to the Ministry of Health’s classification rules within the Mexican Pharmacopoeia.  

Foreign Manufacturers with no legal office in Mexico will need to appoint a Mexico Registration Holder to serve as your in-country authorised representative and manage your device registration process with COFEPRIS.

Entering the Mexico meddev market: regulatory pathways

There are two main regulatory pathways for medical device submissions. The Equivalency Review Process  is used If your device has been approved in the US, Canada, or Japan, the equivalency review route requires the submission of a summary device technical dossier with less detailed technical information. The Standard Review Process for a device without reference agency approval involves increased technical documentation and approval timelines which are much longer than an equivalency review.

Manufacturers must show proof of a certified Quality Management Systems (ISO 13485). For some lower-class devices this may not be required. 

Low risk class devices require a manufacturer to submit applications with basic company and device information, these will generally be subject to faster review and approval.

Registration documentation and technical information should then be formed depending on the review process route taken. The manufacturers in market Mexico Registration Holder will make the submission to COFEPRIS for review and on successful approval a registration certification is issued.

Final things to consider to enter the medical device market in Mexico:

  • The process for Low Risk medical devices is much quicker that other classes with registration taking around 1 to 3 months. The documents required are mainly administrative, however they must still comply with regulations and post market obligations.
  • Family grouping of medical devices can affect the number of registrations you will be required to complete. Family grouping will depend on factors such as Intended Use, Raw Materials, difference between product in the same group. A grouping strategy should be discussed and agreed with the company’s regulatory functions and the in market agent.

For more detailed information on the requirements for accessing India with your product contact us at hello@imedconsultancy.com 

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