{"id":1935,"date":"2021-09-20T21:55:30","date_gmt":"2021-09-20T21:55:30","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1935"},"modified":"2025-05-16T23:33:14","modified_gmt":"2025-05-16T23:33:14","slug":"good-manufacturing-practices-certificate-issued-by-cofepris","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/good-manufacturing-practices-certificate-issued-by-cofepris\/","title":{"rendered":"Good Manufacturing Practices certificate issued by COFEPRIS"},"content":{"rendered":"<p>In a <a href=\"https:\/\/veraqueconsulting.com\/mx\/mdsap-and-how-to-use-it-in-mexico\/\" target=\"_blank\" rel=\"noopener\">previous article<\/a>, we talked about the Good Manufacturing Practices (GMPs) certificates that can be used in Mexico. This certificate is broadly used in the Medical Device Industry, and it is a way to demonstrate that processes are followed to guarantee the quality of the product.<\/p>\n<p>&nbsp;<\/p>\n<p>In this document, we will discuss about the Good Manufacturing Practices issued by COFEPRIS for <strong>medical devices made in Mexico<\/strong>. This is particularly interesting, for those International medical device companies looking to expand their manufacturing facilities to other countries.<\/p>\n<p>&nbsp;<\/p>\n<h2><strong>GMP Certificate<\/strong><\/h2>\n<p>&nbsp;<\/p>\n<p>In Mexico, the Good Manufacturing Practices certificate is applicable to the manufacture of medicines, medical devices or other health supplies manufactured and marketed <strong>in the country<\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p>The Mexican regulations related to GMP\u2019s are:<\/p>\n<ul>\n<li>The General Law of Health<\/li>\n<li>Regulations for Health Supplies<\/li>\n<li>Regulations from the General Law of Health regarding to Controls for Health-related Activities, Establishments, Products and Services<\/li>\n<li>NOM-241-SSA1, Good Manufacturing Practices for the establishments dedicated to produce medical devices<\/li>\n<li>This standard defines all the regulatory conditions to be audited and considers both, documentary and infrastructure requirements for the manufacturing facility.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Any medical device manufacturer interested to establish a <strong>health supplies manufacturing site in Mexico<\/strong>, must satisfy the above-mentioned regulations before requesting a GMP certificate. It is worth mentioning, that this is not mandatory if the facility is located abroad the Mexican republic. That being the case (having a facility outside Mexico), it is still necessary to present a GMP certificate like ISO 13485, MDSAP, CE certificate, or the GMPs certificate released by the Ministry of Health in the country of origin.<\/p>\n<p>&nbsp;<\/p>\n<p>Then, in order to receive the GMPs certificate from COFEPRIS, the first step is to apply for a <a href=\"https:\/\/www.gob.mx\/tramites\/ficha\/visita-de-verificacion-sanitaria-para-certificacion-de-buenas-practicas-de-fabricacion-de-farmacos-medicamentos-y-otros-insumos-para-la-salud-en-establecimientos-ubicados-en-mexico-y-en-el-extranjero-para-el-otorgamiento-o-prorroga-del-registro-sanitario\/COFEPRIS4267\" target=\"_blank\" rel=\"noopener\">Sanitary Verification Visit<\/a> (an audit). For such visit, it is necessary to comply with the following requirements:<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Official Format (COFEPRIS-05-016-C)<\/li>\n<li>Payment of fees<\/li>\n<li>General data of the establishment<\/li>\n<li>Medical device(s) to be audited<\/li>\n<li>Establishments involved in the manufacturing process<\/li>\n<li>Process carried out in each establishment<\/li>\n<li>Indication of use of the medical device(s) to be audited<\/li>\n<li>Person designated to attend the visit<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>On the other hand, the technical requirements are:<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Organizational charts<\/li>\n<li>Description of the production areas<\/li>\n<li>Flowchart of the manufacturing processes<\/li>\n<li>Summary of the Quality Management System<\/li>\n<li>Validation and qualification reports.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>This process is mandatory for all manufacturers located in Mexico, but optional for foreign manufacturers. For instance, it could be useful when the manufacturer that will register and sell their products in Mexico, is not able to provide a GMP or ISO 13485 certificate.<\/p>\n<p>&nbsp;<\/p>\n<p><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">In more recent developments,<\/span> <\/span><span class=\"TextRun Underlined SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">an <\/span><\/span><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5752433&amp;fecha=20\/03\/2025#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span class=\"FieldRange SCXW207134159 BCX0\"><span class=\"TextRun Underlined SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW207134159 BCX0\" data-ccp-charstyle=\"Hyperlink\">agreement was published <\/span><\/span><\/span><span class=\"TextRun Underlined SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">o<\/span><\/span><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">n March 20<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">,<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\"> 2025,<\/span> <span class=\"NormalTextRun SCXW207134159 BCX0\">regarding<\/span> <\/span><\/a><span class=\"FieldRange SCXW207134159 BCX0\"><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW207134159 BCX0\">COFEPRIS criteria for<\/span><\/span><span class=\"TextRun Underlined SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW207134159 BCX0\" data-ccp-charstyle=\"Hyperlink\"> documents that guarantee GMP.<\/span><\/span><\/span><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"> <span class=\"NormalTextRun SCXW207134159 BCX0\">According to this announcement, the MDSAP certificate will <\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">continue to<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\"> be recognized as an equivalent to GMP for new registrations, renewals, and modifications of sanitary <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207134159 BCX0\">registr<\/span><\/span><span class=\"TrackedChange SCXW207134159 BCX0\"><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207134159 BCX0\">ations<\/span><\/span><\/span><span class=\"TextRun SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">. <\/span><\/span><em><span class=\"TextRun Underlined SCXW207134159 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW207134159 BCX0\">This recognition applies <\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">solely <\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">to products manufactured outside Mexican territory<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\"> or manufacture<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">rs <\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">establis<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\">hed<\/span><span class=\"NormalTextRun SCXW207134159 BCX0\"> in national territory, subcontracted by the legal manufacturer of the medical device abroad.<\/span><\/span><span class=\"EOP SCXW207134159 BCX0\" data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/em><\/p>\n<p>&nbsp;<\/p>\n<p>It is important to note that the validity and application of the contents of this announcement rely solely on COFEPRIS\u2019 criteria. We will closely monitor any further developments related to this new announcement.<\/p>\n<p>&nbsp;<\/p>\n<p>If you have questions or need help obtaining Certificates issued by COFEPRIS please contact us at <a href=\"mailto:contact@veraqueconsulting.com\">contact@veraqueconsulting.com<\/a> or visit our <a href=\"https:\/\/veraqueconsulting.com\/mx\/guides\/\" target=\"_blank\" rel=\"noopener\">guidelines<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In a previous article, we talked about the Good Manufacturing Practices (GMPs) certificates that can be used in Mexico. This certificate is broadly used in the Medical Device Industry, and it is a way to demonstrate that processes are followed to guarantee the quality of the product. &nbsp; In this document, we will discuss about [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1936,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-1935","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico"],"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>Good Manufacturing Practices certificate issued by COFEPRIS - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Find more details about Good Manufacturing Practices for companies located in Mexico. 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