{"id":2972,"date":"2022-09-06T17:08:40","date_gmt":"2022-09-06T17:08:40","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=2972"},"modified":"2025-10-14T20:56:12","modified_gmt":"2025-10-14T20:56:12","slug":"letters-of-authorization","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/letters-of-authorization\/","title":{"rendered":"Letters of Authorization"},"content":{"rendered":"<p class=\"ai-optimize-23 ai-optimize-introduction\"><span data-contrast=\"auto\">A Letter of Authorization (LoA), also known as Letter of Representation, is a type of agreement between two companies in which one authorizes the other to perform certain activities and get responsibilities on behalf of the first company. In this article, we will explain the use of LoAs for the Medical Device industry in Mexico.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-25\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-26\"><span data-contrast=\"auto\">LoAs are an essential requirement to register a medical device in Mexico. This document must be issued by the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/the-medical-device-manufacturer-definition-the-mexico-case\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Manufacturer<\/span><\/a><span data-contrast=\"auto\"> of the medical device on favor of the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/holding-services\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Mexican Registration Holder<\/span><\/a><span data-contrast=\"auto\"> (MRH) or local importer\/distributor.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-27\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-28\"><span data-contrast=\"auto\">According to the <\/span><a href=\"http:\/\/www.ordenjuridico.gob.mx\/Documentos\/Federal\/pdf\/wo88318.pdf\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Regulation on Health Supplies<\/span><\/a><span data-contrast=\"auto\"> Articles 161 and 180, LoAs must have the following requirements:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-29\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol>\n<li class=\"ai-optimize-30\"><span data-contrast=\"auto\"> Only required when products are not manufactured in Mexico.<\/span><\/li>\n<li class=\"ai-optimize-31\"><span data-contrast=\"auto\">Need to be authenticated in the country of origin through Legalization or <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/process-to-apostille-legal-documents\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Apostille<\/span><\/a><span data-contrast=\"auto\">.<\/span><\/li>\n<\/ol>\n<p class=\"ai-optimize-32\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-33\"><span data-contrast=\"auto\">Additionally, it is recommended that LoAs include the following points:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-34\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-35\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Include the manufacturer\u2019s name and address. It is suggested to be mentioned exactly as in the GMP (Good Manufacturing Practice) Certificate.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-36\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Indicate the MRH and\/or importer\/distributor legal name and address as appears in the tax ID.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-37\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">List the activities that the manufacturer authorizes the MRH and\/or <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#stakeholders\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">importer\/distributor<\/span><\/a><span data-contrast=\"auto\"> to do, such as: importation, distribution, storage, marketing, participation in tenders, service, being able to participate in registrations and other regulatory procedures in <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#cofepris\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">COFEPRIS<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-38\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">It can be related to all the manufacturer products or certain devices.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-39\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">May appoint the MRH and\/or importer\/distributor as exclusive or non-exclusive distributor.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-40\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Should include the date of issuance and validity (typically 5 years)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-41\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"7\" data-aria-level=\"1\"><span data-contrast=\"auto\">Must include the manufacturer letterhead and be signed by a person with authority to sign contracts (Owners, Directors, Managers, etc.)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-42\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"8\" data-aria-level=\"1\"><span data-contrast=\"auto\">The LoA is then Notarized and authenticated in the country of origin<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-43\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"9\" data-aria-level=\"1\"><span data-contrast=\"auto\">Can be in Spanish or <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/new-amendments-in-the-regulation-for-medical-devices-in-mexico-less-translation-requirements-and-easier-renewal-processes-among-the-important-updates\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">other language<\/span><\/a><span data-contrast=\"auto\">.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p class=\"ai-optimize-44\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-45\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-46\"><b><span data-contrast=\"auto\">Conclusions<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-47\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-48\"><span data-contrast=\"auto\">LoAs are key documents issued by foreign manufacturers to allow companies in Mexico to register or distribute medical devices. These documents must accomplish legal requirements and consider additional points to have control of registrations and sales. If you need help building your letter of representation please contact us at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Letter of Authorization (LoA), also known as Letter of Representation, is a type of agreement between two companies in which one authorizes the other to perform certain activities and get responsibilities on behalf of the first company. In this article, we will explain the use of LoAs for the Medical Device industry in Mexico.\u00a0 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2973,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-2972","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>Letters of Authorization | Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Letters of authorization requirements for the Medical Device Industry in Mexico. 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