{"id":1862,"date":"2021-06-29T17:27:11","date_gmt":"2021-06-29T17:27:11","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1862"},"modified":"2026-04-27T23:24:31","modified_gmt":"2026-04-27T23:24:31","slug":"updates-on-the-equivalency-agreement-for-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/updates-on-the-equivalency-agreement-for-medical-devices-in-mexico\/","title":{"rendered":"Updates on the Equivalency Agreement for Medical Devices in Mexico"},"content":{"rendered":"

Content Update & Historical Note:<\/strong><\/em> This article reflects the regulatory framework as it stood in June 2021 and is retained for historical context and tracking the evolution of Mexican regulations. Since this publication, the framework has been significantly updated. For the most current, authoritative, and expanded list of recognized regulatory authorities, we strongly recommend reading our latest analysis:<\/p>\n

Mexico\u2019s Expanded Equivalency Agreement for Medical Devices: Key Implications<\/span><\/span><\/span><\/a>\u00a0<\/span><\/p>\n

 <\/p>\n

The 2021 Regulatory Landscape<\/strong><\/h3>\n

On June the 22nd 2021, the Ministry of Health in Mexico released an update to the Equivalency Agreements that was applicable for Pharmaceuticals and Medical Devices. This Agreement also emphasizes the possibility to import medical devices in Mexico without a sanitary registration.<\/p>\n

 <\/p>\n

This summary outlines the facts as they were reported in 2021. While this was then a significant update from COFEPRIS, it has since been superseded by more recent decrees.<\/p>\n

 <\/p>\n

2021 Extended Equivalency Agreement: A Retrospective<\/strong><\/h3>\n

 <\/p>\n

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, on November 2020, the Ministry of Health in Mexico shortened the timelines for those products requested through this regulatory route.<\/p>\n

 <\/p>\n

With the June 2021 announcement, COFEPRIS expanded its recognition as follows:<\/p>\n

 <\/p>\n\n\n\n\n
Regarding Pharmaceuticals<\/td>\n<\/tr>\n
–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Australia.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Brazil.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Canada.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 European Union.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Japan.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 South Korea.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Switzerland.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 United Kingdom.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 United States.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n
Regarding Medical Devices<\/td>\n<\/tr>\n
–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Canada.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Japan.<\/strong><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 United States.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Note: For the current and expanded list of countries recognized today, please see our updated guide.<\/a><\/span><\/span><\/span>.<\/span><\/span><\/span><\/em>\u00a0<\/span><\/p>\n

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.<\/p>\n

 <\/p>\n

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

 <\/p>\n

Medical Devices without sanitary registration<\/strong><\/h3>\n

 <\/p>\n

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.<\/p>\n

 <\/p>\n

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

 <\/p>\n

Final\u00a0<\/span><\/b>Notes<\/span><\/b>\u00a0<\/span><\/h3>\n

While the 2021 agreement provided clarity on several points, the regulatory path in Mexico has continued to evolve. The information above should be used for historical reference only.<\/span>\u00a0<\/span><\/p>\n

For strategic consulting on the current\u00a0equivalency routes and how to\u00a0leverage\u00a0the most recent “Expanded Agreement,” please visit our latest post<\/a> or contact us directly at contact@veraqueconsulting.com.<\/span>\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Content Update & Historical Note: This article reflects the regulatory framework as it stood in June 2021 and is retained for historical context and tracking the evolution of Mexican regulations. Since this publication, the framework has been significantly updated. For the most current, authoritative, and expanded list of recognized regulatory authorities, we strongly recommend reading […]<\/p>\n","protected":false},"author":2,"featured_media":1863,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-1862","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico"],"yoast_head":"\nUpdates on the Equivalency Agreement for Medical Devices in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Find more details about the 2021 equivalency agreement in Mexico for Pharmaceuticals and Medical Devices. 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