{"id":1209,"date":"2021-01-25T02:26:47","date_gmt":"2021-01-25T02:26:47","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1209"},"modified":"2026-03-17T16:48:34","modified_gmt":"2026-03-17T16:48:34","slug":"technovigilance-for-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/technovigilance-for-medical-devices-in-mexico\/","title":{"rendered":"Technovigilance for Medical Devices in Mexico"},"content":{"rendered":"<p><span data-contrast=\"auto\">Technovigilance,\u00a0or Medical Device Surveillance,\u00a0is the activity that\u00a0ensures\u00a0that any medical technology in Mexico is correctly working and describes how to report any incident related to the device.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In this\u00a0article, we summarize the\u00a0technovigilance\u00a0requirements in Mexico, including:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">How to\u00a0identify\u00a0an adverse incident<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">When to report and when not to report an incident<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Responsible entities and reporting timelines<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Recent institutional changes in\u00a0technovigilance\u00a0authorities<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Legal Framework<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The Mexican Official Standard for\u00a0technovigilance\u00a0is the\u00a0<a href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=5275834&amp;fecha=30\/10\/2012#gsc.tab=0\" target=\"_blank\" rel=\"noopener\">NOM-240-SSA-2012<\/a> which establishes the requirements for installing, operating, and maintaining a technovigilance system in Mexico.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">This standard is aligned with other national and international regulations related to medical device post-market surveillance and vigilance systems.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">NOM-240-SSA-2012 applies exclusively to incidents that occur within Mexican territory. However, when an incident is reported in Mexico, the authority must also be informed about any corrective or preventive actions implemented both locally and in other countries, when applicable.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Recent Institutional Update<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:246,&quot;335559739&quot;:246,&quot;335559740&quot;:300}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Following the\u00a0<\/span><a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5778298&amp;fecha=15\/01\/2026#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Decree that reforms the General Health Law<\/span><\/a><span data-contrast=\"auto\">\u00a0\u00a0published on\u00a0January 15\u00a0and\u00a0<\/span><a href=\"https:\/\/www.gob.mx\/cofepris\/es\/articulos\/surge-el-centro-nacional-de-farmacovigilancia-y-tecnovigilancia-cenafyt?idiom=es\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">as communicated by COFEPRIS<\/span><\/a><span data-contrast=\"auto\">, the National Center of Pharmacovigilance (CNFV) has evolved into the<\/span><b><span data-contrast=\"auto\">\u00a0National Center for Pharmacovigilance and\u00a0Technovigilance\u00a0(CENAFyT)<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">This institutional evolution reflects the growing importance of\u00a0technovigilance\u00a0and medical devices within Mexico\u2019s health surveillance system, formally integrating pharmacovigilance and\u00a0technovigilance\u00a0activities under a single, strengthened authority.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Key Definitions<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The following definitions are essential for understanding\u00a0technovigilance\u00a0requirements in Mexico. For\u00a0additional\u00a0terms,<\/span><span data-contrast=\"auto\">\u00a0we suggest checking the\u00a0<\/span><a href=\"http:\/\/dof.gob.mx\/nota_detalle.php?codigo=5275834&amp;fecha=30\/10\/2012\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">norm<\/span><\/a><span data-contrast=\"auto\">\u00a0or feel free to\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">get in touch with us<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Incident<\/span><\/b><span data-contrast=\"auto\">: any event related to a medical device.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Adverse Incident<\/span><\/b><span data-contrast=\"auto\">: any event related to a medical device, caused by a malfunction and that could lead to death or health deterioration.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\"><b><span data-contrast=\"auto\">CENAFyT<\/span><\/b><span data-contrast=\"auto\">: The National Center for Pharmacovigilance and\u00a0Technovigilance, the authority responsible for receiving, assessing, and\u00a0monitoring\u00a0reported adverse incidents related to medicines and medical devices in Mexico.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\"><b><span data-contrast=\"auto\">Notification<\/span><\/b><span data-contrast=\"auto\">:\u00a0the act\u00a0<\/span><span data-contrast=\"auto\">of informing CENAFyT about the occurrence of an incident. Notifications may be\u00a0initial, follow-up, or final.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">When to report and\u00a0when\u00a0not to report an incident<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">We have defined an adverse incident and an incident, but it is still a vague description to\u00a0identify\u00a0when to\u00a0get in contact with\u00a0the authorities. Therefore, we provide a summary of when to report and not to report an incident:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">You need to report an incident in case any of the following 3 points prevails:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h5><b><span data-contrast=\"auto\">Point 1<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h5>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">It is related to a malfunction that caused\u00a0the\u00a0adverse incident.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">It is an\u00a0unpredicted\u00a0adverse incident. In other words, an adverse incident\u00a0not\u00a0identified\u00a0by the manufacturer during the risk evaluation.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Labels or manuals provide inaccurate information that caused the adverse incident.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">The medical device has interactions with other products or substances that lead to\u00a0the adverse incident.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">There are False Positives or Negatives in Diagnostic devices that lead to the adverse incident.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h5><b><span data-contrast=\"auto\">Point 2<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h5>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">The incident is related to\u00a0the medical device.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h5><b><span data-contrast=\"auto\">Point 3<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/h5>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">The incident caused or could cause patient death or important health deterioration.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">You do not need to report an incident when:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">The malfunction was detected\u00a0prior\u00a0the device usage. In the meantime, the malfunction would not cause death or important health deterioration.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">When the\u00a0patient\u00a0condition was the real cause of the event.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Expired devices were used.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">Responsible parties<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A surveillance program is part of any entity or party related to the medical device. Even patients,\u00a0nurses\u00a0and physicians are encouraged to report an incident. Nevertheless, the norm clearly\u00a0states\u00a0that\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/holding-services\/?\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">the sanitary registration holder<\/span><\/a><span data-contrast=\"auto\">\u00a0as the local representant of the device manufacturer, is the main responsible of handling the\u00a0technovigilance\u00a0program in Mexico.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In other words, any manufacturer outside in Mexico who has registered his products in Mexico, must be sure who acts as its Mexican Registration Holder\u00a0in order to\u00a0request any feedback related to incidents in Mexico or even worldwide. You can check more details about your specific role in\u00a0our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/mexican-registration-holder-ultimate-guide\/#technovigilance\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">guides<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Timelines to notify an event<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">As a result of the efforts of the MoH (Ministry of Health) to make the\u00a0Technovigilance\u00a0accessible and for more people, any notification can be performed online via the\u00a0<\/span><a href=\"https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/sistema-en-linea-de-notificacion-de-incidentes-adversos-de-dispositivos-medicos\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">COFEPRIS webpage<\/span><\/a><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">The sanitary registration holder must notify adverse incidents within the following timelines:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Public health threat: within\u00a02 working days<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Death or serious health deterioration: within\u00a010 calendar days<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&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\">Any other adverse incident: within\u00a030 calendar days<\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">Frequently asked questions (<\/span><\/b><b><span data-contrast=\"auto\">FAQ)<\/span><\/b><\/h3>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<ol>\n<li><strong>What is technovigilance in Mexico?\n<p><\/strong><span data-contrast=\"auto\">Technovigilance\u00a0is the post-market surveillance system that\u00a0monitors\u00a0the safety and performance of medical devices used in Mexico. Its purpose is to detect, evaluate, and prevent adverse incidents that could affect patient safety or public health.<\/span><\/li>\n<li><strong>What authority receives technovigilance reports?\n<p><span data-contrast=\"auto\"><br \/>\n<\/span><\/strong>As of March 2024,\u00a0technovigilance\u00a0reports are evaluated by\u00a0<strong>CENAFyT<\/strong> (National Center for Pharmacovigilance and\u00a0Technovigilance), following its evolution from the former CNFV.<strong><\/p>\n<p><\/strong><\/li>\n<li><strong>Does the change from CNFV to CENAFyT affect technovigilance obligations?\n<p><\/strong><br \/>\nIn practice, no.<\/p>\n<p>The reporting obligations, timelines, and responsibilities established in NOM-240-SSA-2012 remain unchanged. The institutional change mainly seeks to strengthen and modernize the surveillance framework, with a strong focus on updating the NOM-240 Technovigilance Standard in the future.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><\/h3>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">We have identified when to report and when not to report incidents, timelines and responsible parties in Mexico. Nevertheless, the authority encourages to promote the pro notification criteria in cases it is not clear to report or not.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although not discussed in this article, even if no incidents are reported during a\u00a05 year\u00a0period, it is still necessary to present a\u00a0Technovigilance\u00a0report to the authorities, as a requirement of the extension of the registration. You can find more details in\u00a0our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#routes\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">Regulatory Guide<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Please, contact us at\u00a0<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"auto\">contact@veraqueconsulting.com<\/span><\/a><span data-contrast=\"auto\">\u00a0to know more about this topic or any other question you may have about the sanitary regulation in Mexico. You can also check\u00a0our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/guides\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"auto\">guidelines<\/span><\/a><span data-contrast=\"auto\">\u00a0with more details about the regulatory process in Mexico.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Technovigilance,\u00a0or Medical Device Surveillance,\u00a0is the activity that\u00a0ensures\u00a0that any medical technology in Mexico is correctly working and describes how to report any incident related to the device.\u00a0 \u00a0 In this\u00a0article, we summarize the\u00a0technovigilance\u00a0requirements in Mexico, including:\u00a0 How to\u00a0identify\u00a0an adverse incident\u00a0 When to report and when not to report an incident\u00a0 Responsible entities and reporting timelines\u00a0 Recent [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1210,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[381,390],"tags":[20,23,385],"class_list":["post-1209","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cofepris","category-mexico","tag-cofepris","tag-medical-device","tag-technovigilance"],"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>Technovigilance for Medical Devices in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Get more details about the surveilance norm in the country. 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