{"id":698,"date":"2020-02-27T20:28:25","date_gmt":"2020-02-27T20:28:25","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=698"},"modified":"2025-07-18T20:47:17","modified_gmt":"2025-07-18T20:47:17","slug":"new-cofepris-submission-guide","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/new-cofepris-submission-guide\/","title":{"rendered":"New Cofepris submission guide"},"content":{"rendered":"

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 <\/p>\n

Introduction<\/strong><\/h3>\n

Last 20 February 2020, COFEPRIS<\/a> issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS<\/a>) \u2013a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations.<\/p>\n

In this article we highlight the main features you have to consider before submitting a request (here referred as \u201cthe dossier\u201d) to COFEPRIS. We focus only on submissions related with medical devices.<\/p>\n

 <\/p>\n

Characteristics of the dossier<\/strong><\/h3>\n

Considering that paper is used in the majority of the submissions. COFEPRIS has settled in this guide that all the dossiers presented in paper must have the following features:<\/p>\n

    \n
  1. Organized in separated files containing a maximum of 500 sheets each one.<\/li>\n
  2. Fastened with aluminum screw posts of adequate size to avoid loose sheets.<\/li>\n
  3. Use sheet protectors to save original documents that should not be perforated nor foliated (e.g. legal documents).<\/li>\n
  4. Identify each individual file with a printed label containing:\n
      \n
    1. Type of submission.<\/li>\n
    2. Company name.<\/li>\n
    3. Generic or distinctive name for the medical device.<\/li>\n
    4. File number.<\/li>\n
    5. Total files in the dossier.<\/li>\n<\/ol>\n<\/li>\n
    6. The cover color in all files, depending on the type of request, must be:<\/li>\n<\/ol>\n\n\n\n\n\n\n\n
      Type of request<\/strong><\/td>\nColor<\/strong><\/td>\n<\/tr>\n
      New sanitary registration<\/td>\nDark green<\/td>\n<\/tr>\n
      Extension of sanitary registration<\/td>\nPurple<\/td>\n<\/tr>\n
      Technical modification<\/td>\nOrange<\/td>\n<\/tr>\n
      Administrative modification<\/td>\nYellow<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/p>\n

      Moreover, you should avoid: <\/em><\/p>\n

        \n
      1. Perforate relevant information and seals.<\/li>\n
      2. Use sheet protectors for ordinary documents.<\/li>\n
      3. Underline, cross out, hide or highlight text.<\/li>\n
      4. Use sheet separators, adhesive strips (Post-it) and blank sheets.<\/li>\n<\/ol>\n

        Finally, it is recomended:<\/em><\/p>\n

          \n
        1. Print sheets by both sides.<\/li>\n
        2. Write \u201cNo Text\u201d in the back of one side printed sheets.<\/li>\n<\/ol>\n

           <\/p>\n

          Sheets numbering<\/strong><\/h3>\n

          <\/h3>\n

          The specifications for numbering all sheets contained in the dossier are as follow:<\/h4>\n