Updates on the Equivalency Agreement for Medical Devices in Mexico

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Last June the 22nd 2021, the Ministry of Health in Mexico released an update to the Equivalency Agreements that is applicable for Pharmaceuticals and Medical Devices. This Agreement also emphasizes the possibility to import medical devices in Mexico without a sanitary registration.

 

In this document we will summarize the main facts related to medical devices. It is worth mentioning that this is a new update from COFEPRIS, and there are still questions about how it will work.

 

Extended Equivalency Agreements

 

The equivalency agreement model is not new in Mexico. Before this update, the equivalency agreement recognized authorizations from Canada, Japan and the USA. In fact, last November 2020, the Ministry of Health in Mexico shortened the timelines for those products requested through this regulatory route.

 

Now, with this new announcement, COFEPRIS is recognizing equivalency with the following countries:

 

Regarding Pharmaceuticals
–          Australia.

–          Brazil.

–          Canada.

–          European Union.

–          Japan.

–          South Korea.

–          Switzerland.

–          United Kingdom.

–          United States.

 

Regarding Medical Devices
–          Canada.

–          Japan.

–          United States.

 

Even though, there are still questions about the documents to be submitted for this route, the fact is that legal timelines responses shall be shortened half the time. This should be no more than 15 working days for Class I medical devices or 30 working days for Class III medical devices. In practice, these timelines may be extended.

 

In addition, this agreement also emphasizes that documents in Spanish or English do not need to be translated, as reported last May the 31st 2021. Regarding this point, Veraque had the opportunity to assist to the last COFEPRIS training center event held on June 25th 2021. In this meeting, COFEPRIS authorities stated that documents in Spanish or English do not require translations.

 

Medical Devices without sanitary registration

 

This agreement also announces that in case a manufacturer wins a national bid, it is possible to request a temporal import permit without a sanitary registration to start exporting the product to Mexico. The last will prevail, as long as the manufacturer, through their legal representative in Mexico, starts the registration process within the 10 days upon the first importation.

 

In other words, it can be inferred from the last paragraph that manufacturers can participate in national tenders without a sanitary registration in Mexico. This is also part of the efforts of the Mexican government to work with international agencies like the World Health Organization.

 

Notes

 

Even though the agreement is clear about the equivalency recognition, there are still many questions about how the regulatory route will work. Veraque will be providing updates about this. In the meantime, if you have any question or comment about this new equivalency agreement, feel free to contact us at contact@veraqueconsulting.com