{"id":640,"date":"2020-01-24T18:55:22","date_gmt":"2020-01-24T18:55:22","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=640"},"modified":"2024-04-18T03:04:30","modified_gmt":"2024-04-18T03:04:30","slug":"equivalency-agreement-summary","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/equivalency-agreement-summary\/","title":{"rendered":"Equivalency Agreement summary"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignnone wp-image-242\" role=\"img\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/12\/prvntion.svg\" alt=\"\" width=\"98\" height=\"98\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization. The aforementioned authorization is a document called Sanitary Registration, which <a href=\"https:\/\/www.gob.mx\/cofepris\" target=\"_blank\" rel=\"noopener noreferrer\">COFEPRIS<\/a> (the Mexican FDA) issues after evaluating a set of requirements.<\/p>\n<p>In addition, there are <strong>two ways<\/strong> to obtain the Sanitary Registration:<\/p>\n<p>The <em><a href=\"https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/registro-de-dispositivos-medicos-nuevos\" target=\"_blank\" rel=\"noopener noreferrer\">ordinary process<\/a><\/em> and the <em>equivalency agreement.<\/em><\/p>\n<p>On the other hand, COFEPRIS has determined that the requirements to get the Sanitary Registration of a medical device in Mexico by the ordinary process are similar (<em>Equivalent<\/em>) to that needed for approval of a medical device in the <a href=\"http:\/\/dof.gob.mx\/nota_detalle.php?codigo=5164641&amp;fecha=26\/10\/2010\" target=\"_blank\" rel=\"noopener noreferrer\">United States of America, Canada<\/a> or <a href=\"http:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5231033&amp;fecha=25\/01\/2012\" target=\"_blank\" rel=\"noopener noreferrer\">Japan<\/a> respectively. Hence COFEPRIS created the <strong>equivalency agreements.<\/strong><\/p>\n<p>In order to be eligible to apply for the <strong>equivalency agreement <\/strong>route,\u00a0a series of requirements must be fulfilled. The most important is to hold a valid approval from either the <a href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_blank\" rel=\"noopener noreferrer\">Food and Drug Administration (FDA)<\/a>, <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices.html\" target=\"_blank\" rel=\"noopener noreferrer\">Health Canada<\/a> or <a href=\"https:\/\/www.pmda.go.jp\/english\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">the Ministry of Health Welfare and Labor<\/a> depending on which country the medical device has been approved for its marketing.<\/p>\n<p>There are many perks of requesting a sanitary registry through the equivalency agreement pathway, specifically:<\/p>\n<ul>\n<li>Less technical and legal documentation is requested by COFEPRIS.<\/li>\n<li>The review and approval times are shorter<\/li>\n<li>Reduced translation costs.<\/li>\n<\/ul>\n<p>However, the equivalency agreement is not exempt of drawbacks. For instance, it could be harder to get the medical device approved in one of the countries listed above.<\/p>\n<p>In addition, the rules in these countries may change and gather the right documentation to be submitted to COFEPRIS can be complicated or time consuming.<\/p>\n<p>It is important to notice that this kind of requests are not eligible to be reviewed by an authorized <a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener noreferrer\">third party<\/a>. Therefore, COFEPRIS will review them directly with more strict criteria and the documents and information submitted must be correct to avoid delays and take advantage of this fast track route.<\/p>\n<p><strong>Check similar notes in our <a href=\"https:\/\/veraqueconsulting.com\/mx\/guides\/\" target=\"_blank\" rel=\"noopener noreferrer\">Guides<\/a>.<\/strong><\/p>\n<p><em>We want to thank <a href=\"https:\/\/www.linkedin.com\/in\/hugo-vite-a2807380\/\" target=\"_blank\" rel=\"noopener noreferrer\">Hugo Vite<\/a> for his support on writing this document.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization. The aforementioned authorization is a document called Sanitary Registration, which COFEPRIS (the Mexican FDA) issues after evaluating a set of requirements. In addition, there are two ways to obtain the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":308,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,390],"tags":[8],"class_list":["post-640","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-equivalency-agreement","category-mexico","tag-equivalency-agreement"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Equivalency Agreement summary - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"A brief summary to better understand the equivalency agreement process for medical devices in Mexico. 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