{"id":640,"date":"2020-01-24T18:55:22","date_gmt":"2020-01-24T18:55:22","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=640"},"modified":"2026-10-21T00:46:44","modified_gmt":"2026-10-21T00:46:44","slug":"equivalency-agreement-summary","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/equivalency-agreement-summary\/","title":{"rendered":"Equivalency Agreement summary"},"content":{"rendered":"

Last Updated: October 2026<\/span><\/span><\/span>\u00a0<\/span><\/em><\/p>\n

Every controlled medical device 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<\/a> (the Mexican FDA) issues after evaluating a set of requirements.<\/p>\n

In addition, there are two ways<\/strong> to obtain the Sanitary Registration:<\/p>\n

    \n
  1. The ordinary process<\/a><\/em><\/li>\n
  2. The equivalency agreements<\/em><\/li>\n<\/ol>\n

     <\/p>\n

    COFEPRIS has determined that the requirements to get the Sanitary Registration of a medical device in Mexico by the ordinary process are similar (Equivalent<\/em>) to<\/span><\/span><\/span> to<\/span><\/span><\/span> those evaluated by certain reference regulatory authorities<\/span><\/span><\/span>. <\/span><\/span><\/span>H<\/span>ence,<\/span><\/span><\/span> COFEPRIS created the <\/span><\/span><\/span>equivalency agreements.<\/span><\/span><\/span>\u00a0<\/span><\/strong><\/p>\n

    In order to<\/span><\/span><\/span> be eligible to apply for the <\/span><\/span><\/span>equivalency agreement <\/span><\/span><\/span>route, a series of requirements must be fulfilled. <\/span><\/span><\/span> The most important is to hold a valid approval from a recognized reference regulatory authority eligible under the applicable equivalency agreement, including authorities from Australia, Brazil, Canada<\/span><\/span><\/span> (Health Canada)<\/span><\/span><\/a><\/span>, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom and the United States of America<\/span><\/span><\/span> (<\/span><\/span><\/span>FDA<\/span><\/span><\/span><\/a>)<\/span><\/span><\/span>.<\/span><\/span><\/span>\u00a0<\/span><\/p>\n

    There are many perks of requesting a sanitary registry through the equivalency agreement pathway, specifically:<\/p>\n