{"id":28485,"date":"2023-07-07T10:59:32","date_gmt":"2023-07-07T08:59:32","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=28485"},"modified":"2023-08-04T12:14:08","modified_gmt":"2023-08-04T10:14:08","slug":"mexico-registration-renewal-and-amendment-management-procedure-changed","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/07\/07\/mexico-registration-renewal-and-amendment-management-procedure-changed\/","title":{"rendered":"MEXICO: Registration renewal and amendment management procedure changed"},"content":{"rendered":"<h2>La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) published in the <a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5688295&amp;fecha=10\/05\/2023#gsc.tab=0\"><strong><em>Diario Oficial de la Federaci\u00f3n<\/em><\/strong><\/a>\u00a0on 10\/05\/2023 the update of the requirements for the <strong>renewal of the registration<\/strong> and for the submission of any post-registration <strong>changes<\/strong> of the medical device.<\/h2>\n<p>Concerning the requirements for <strong>renewing<\/strong> the registration of a medical device, it is stated that applications will be confirmed by a simple <strong>notification<\/strong> demonstrating the timeliness of the submission. The issued notification must be submitted together with the reference registration and retains the same <strong>registration number<\/strong>. The renewal process can be carried out electronically.<\/p>\n<p>The process for communicating <strong>post-registration changes<\/strong> to the Mexican Regulatory Authority varies according to the nature of the change to be made: <strong>administrative<\/strong> or <strong>technical<\/strong>. Administrative changes refer to <strong>transfers of rights<\/strong>, <strong>change of name<\/strong> <strong>or address of the foreign distributor<\/strong> and <strong>change of legal manufacturer <\/strong>and must be communicated by letter issued by the manufacturer within a period not exceeding 30 working days from the date on which the transfer agreement, change of name or address of the foreign distributor took place.<\/p>\n<p>Technical changes, on the other hand, concern <strong>a change of production site or the creation of new production sites<\/strong>, a change of <strong>classification of the medical device<\/strong> and a <strong>change of the expiry date<\/strong>. The notification of the change of production site or the creation of new production sites must specify the new references in detail, including information such as company name and address. On the other hand, the change of device classification must be supported by a risk assessment, and the change of expiry date must include real time shelf-life tests, in accordance with the requirements of <a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/03\/Norma-Oficial-Mexicana-NOM-241-SSA1-2021-ENG-REV.pdf\"><strong><em>NOM-241-SSA1-2021<\/em><\/strong><\/a>.<\/p>\n<p>By simplifying the procedure for handling renewals and post-registration changes, COFEPRIS thus demonstrates its intention to increase the interest of manufacturers to market their medical devices in Mexico, guaranteeing users and patients the best care with the most advanced devices.<\/p>\n<p>&gt;&gt;&gt; If you want to market medical devices in Mexico, Thema can assist you with the <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>Strategic-Regulatory Consulting<\/strong><\/a> service, can be your <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/\"><strong>Local Representative<\/strong><\/a> and can support you in <a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\"><strong>registering products<\/strong><\/a> with COFEPRIS.<\/p>\n<p><strong>Source\u00a0:<\/strong><\/p>\n<p><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5688295&amp;fecha=10\/05\/2023#gsc.tab=0\">AVISO referente a la venta del Suplemento para Dispositivos M\u00e9dicos 5.0 de la Farmacopea de los Estados Unidos Mexicanos<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (COFEPRIS) published in the Diario Oficial de la Federaci\u00f3n\u00a0on 10\/05\/2023 the update  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":28492,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-28485","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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