{"id":1951,"date":"2021-10-04T17:10:55","date_gmt":"2021-10-04T17:10:55","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1951"},"modified":"2025-09-26T20:55:24","modified_gmt":"2025-09-26T20:55:24","slug":"low-risk-and-non-regulated-medical-devices","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/low-risk-and-non-regulated-medical-devices\/","title":{"rendered":"Low risk and non-regulated medical devices"},"content":{"rendered":"<p class=\"ai-optimize-26 ai-optimize-introduction\"><span data-contrast=\"auto\">Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the Ministry of Health categorizes medical devices as Class I, II, or III. Additionally, there is a sub-group known as Class I Low Risk, which is not a separate fourth class, but rather a sub-group of Class I devices. There are also products that are not subject to any sanitary control in Mexico, some of these non-regulated devices are identified through official lists.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-27\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-28\"><span data-contrast=\"auto\">This article provides detailed information about non-regulated products and guidance on how to identify them using these official lists. It also outlines the requirements in case your products fall under the Class I Low Risk. It is worth mentioning that Class I Low Risk devices follow a very simple regulatory process, making them a convenient option if you are looking to enter the Mexican market.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-29\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-30\"><b><span data-contrast=\"auto\">Agreements and requirements<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-31\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-32\"><span data-contrast=\"auto\">As mentioned in our\u202f<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Ultimate Guide for Regulatory Affairs in Mexico<\/span><\/a><span data-contrast=\"auto\">, there is a legal framework to define the classification of medical devices in Mexico. Moreover, there are guidelines for the\u202f<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">classification and grouping<\/span><\/a><span data-contrast=\"auto\">\u202fof any medical device according to its intended use and level of risk.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-33\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-34\"><span data-contrast=\"auto\">In addition to existing guidelines and regulations, the Ministry of Health published an updated official list on July 7th, 2025, identifying medical devices considered low-risk, as well as products that, based on their nature, characteristics, and intended use, are not classified as health supplies<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-35\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-36\"><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5762237&amp;fecha=07\/07\/2025#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">This 2025 Agreement<\/span><\/a><span data-contrast=\"auto\"> replaces the obsolete agreements from <\/span><a href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=5227732&amp;fecha=31\/12\/2011#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">2011<\/span><\/a><span data-contrast=\"auto\"> and <\/span><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5376857&amp;fecha=22\/12\/2014#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">2014<\/span><\/a><span data-contrast=\"auto\">. One of its key improvements is the consolidation of both low-risk and non-regulated devices into a single document. Previously, these categories were distributed across separate annexes \u2014one in each of the now outdated documents.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-37\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-38\"><span data-contrast=\"auto\">\u202f<\/span><b><span data-contrast=\"auto\">2025<\/span><\/b> <b><span data-contrast=\"auto\">Agreement \u2013 Annexes<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-39\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-40\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\"><b><span data-contrast=\"auto\">Annex 1: <\/span><\/b><span data-contrast=\"auto\">lists medical devices considered as low risk.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-65\" style=\"list-style-type: none\">\n<ul>\n<li class=\"ai-optimize-41\" data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Some of the products listed include, among others: face masks, surgical clothing, external prostheses and simple wound dressings.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-66\" style=\"list-style-type: none\">\n<ul>\n<li class=\"ai-optimize-42\" data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"auto\">Annex 2: specifies products that do classify as Class I Low Risk medical devices but <\/span><span data-contrast=\"auto\">do not require a sanitary registration<\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"ai-optimize-43\"><span data-ccp-props=\"{&quot;335559685&quot;:1440}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-44\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" 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\"><b><span data-contrast=\"auto\">Annex 3: <\/span><\/b><span data-contrast=\"auto\">lists products not considered as medical devices.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-67\" style=\"list-style-type: none\">\n<ul>\n<li class=\"ai-optimize-45\" data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">This annex includes 1984 products. Some examples included: TV systems (for operating rooms), rehab chairs, and immobilizers.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"ai-optimize-46\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-47\"><span data-contrast=\"auto\">In summary, to find out if a product is considered a low-risk medical device, refer to Annex 1&amp;2. To identify products not classified as medical devices, consult Annex 3 of the 2025 Agreement.\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-48\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-49\"><span data-contrast=\"auto\">It is important to note that some products not listed in the annexes may still be considered Class I Low Risk or non-medical devices. In such cases, a careful <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/services\/classification-and-grouping-assessment\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">classification assessment<\/span><\/a><span data-contrast=\"auto\"> should be made with expert support.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-50\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3 class=\"ai-optimize-51\"><b><span data-contrast=\"auto\">Class I \u2013 Low Risk Medical Devices<\/span><\/b><br \/>\n<span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p class=\"ai-optimize-52\"><span data-contrast=\"auto\">Low-risk medical devices do require sanitary registration. However, compared to the regulatory processes for Class I, II, and III devices, the Class I Low Risk pathway is<\/span><a href=\"https:\/\/checklist.veraqueconsulting.com\/i\/checklist-for-medical-device-registration-class-1-low-risk-devices\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\"> less intricated<\/span><\/a><span data-contrast=\"auto\">. The required documents are mostly administrative:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-53\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li class=\"ai-optimize-54\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Official application format<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-55\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Payment of fees<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-56\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Warehouse notice of the holder and distributor<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-57\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Power of attorney of the applicant<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-58\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Letter of authorization, issued by the manufacturer<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li class=\"ai-optimize-59\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" 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;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Instructions of use<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p class=\"ai-optimize-60\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-61\"><span data-contrast=\"auto\">In other words, at present the Class I low risk regulatory process does not require any technical report or study to be presented. Nevertheless, the\u202f<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/holding-services\/?%22%20\\t%20%22_blank\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Holder<\/span><\/a><span data-contrast=\"auto\">\u202fof these authorizations in Mexico must comply with local regulations (have a medical device warehouse, follow the technovigilance program, etc.). You can find more details about these requirements in the following \u202f<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/when-and-how-to-choose-a-medical-device-distributor-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">article<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-62\"><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-63\"><span data-contrast=\"auto\">In case you need to confirm if your product is considered as a low-risk medical device or is not regulated by COFEPRIS please contact us at\u202f<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p class=\"ai-optimize-64\"><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the Ministry of Health categorizes medical devices as Class I, II, or III. Additionally, there is a sub-group known as Class I Low Risk, which is not a separate fourth class, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1952,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-1951","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>Low risk and non-regulated medical devices - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Find more details on how to find if your products are considered a non-medical device or Class I low risk. 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