{"id":4215,"date":"2026-02-10T18:31:40","date_gmt":"2026-02-10T18:31:40","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=4215"},"modified":"2026-02-11T19:58:09","modified_gmt":"2026-02-11T19:58:09","slug":"cofepris-adverse-incident-reporting-and-registration-holder-mrh-responsibilities","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/cofepris-adverse-incident-reporting-and-registration-holder-mrh-responsibilities\/","title":{"rendered":"COFEPRIS Adverse Incident Reporting and Registration Holder (MRH) Responsibilities"},"content":{"rendered":"<h3><b><span data-contrast=\"auto\">Introduction<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Technovigilance\u00a0in Mexico is a critical post-market surveillance activity that ensures medical devices\u00a0remain\u00a0safe and effective throughout their lifecycle. For\u00a0foreign\u00a0manufacturers entering the Mexican market, understanding adverse incident reporting and the role of the Mexican Registration Holder (MRH) is essential for compliance with NOM-240-SSA1\u00a0and COFEPRIS requirements.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This article explains what constitutes an adverse incident, who\u00a0is responsible for\u00a0reporting, and the timelines and processes involved.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Is\u00a0Technovigilance\u00a0in Mexico?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Technovigilance\u00a0or Medical Device Surveillance\u00a0refers to the systematic monitoring of medical devices after they have been placed on the market. Its goal is to detect, evaluate, and prevent risks associated with device use. In Mexico, this program is regulated by<a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5275834&amp;fecha=30\/10\/2012#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"> NOM-240-SSA1<\/a>, which aligns with international post-market surveillance standards.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Is an Adverse Incident?<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">An adverse incident is any event related to a medical device that results from a malfunction and could lead to death or significant health deterioration.\u00a0<\/span><span data-contrast=\"auto\">Examples\u00a0include:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li 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;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Unexpected device failures\u00a0not\u00a0identified\u00a0during risk evaluation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li 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;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Incorrect labeling or instructions causing harm.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li 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;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Interactions with other products or substances\u00a0leading\u00a0to adverse outcomes.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li 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;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Diagnostic errors (false positives or negatives) that compromise patient safety.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">The Role of the Registration Holder<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">The Mexico Registration Holder\u00a0(MRH)\u00a0is\u00a0the legal representative of the manufacturer and is primarily responsible for implementing and\u00a0maintaining\u00a0the\u00a0technovigilance\u00a0program.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Key responsibilities include:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li 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\">Coordinating incident reporting with manufacturers, distributors, and healthcare providers.<\/span><span data-ccp-props=\"{}\">\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;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\">Ensuring\u00a0timely\u00a0notifications to the National Center of Pharmacovigilance (CNFV) through COFEPRIS.<\/span><span data-ccp-props=\"{}\">\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;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\">Maintaining a\u00a0Technovigilance\u00a0Unit staffed with trained personnel familiar with NOM-240 requirements.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Manufacturers outside Mexico must\u00a0maintain\u00a0close communication with their MRH to ensure compliance and receive feedback on incidents occurring in Mexico or globally.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">COFEPRIS Adverse Incident Reporting Process<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">There are two official channels for reporting:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Hardcopy Submission: Using the official COFEPRIS format and delivering it to the Integral Services Center (CIS).<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Online Platform:\u00a0Submitting\u00a0notifications digitally via the COFEPRIS\u00a0technovigilance\u00a0portal.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Each\u00a0initial\u00a0notification must include:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Sanitary\u00a0Registration\u00a0number<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Device\u00a0identification\u00a0and\u00a0classification<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Description of the incident and its consequences<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Patient\u00a0and\u00a0operator\u00a0details<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" 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\">Actions\u00a0taken\u00a0following\u00a0the\u00a0event<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Follow-up and final notifications are\u00a0required\u00a0to close the case, detailing\u00a0corrective\u00a0and preventive measures.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It is important to note that not every issue involving a medical device is considered reportable. Section 7.2 of NOM\u2011240\u2011SSA1 clearly outlines the criteria for determining which incidents must be reported to COFEPRIS. For a more detailed explanation of these criteria and their appropriate application, you may refer to <a class=\"Hyperlink SCXW71732326 BCX0\" href=\"https:\/\/veraqueconsulting.com\/mx\/technovigilance-for-medical-devices-in-mexico\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW71732326 BCX0\" lang=\"ES-MX\" xml:lang=\"ES-MX\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW71732326 BCX0\" data-ccp-charstyle=\"Hyperlink\">Technovigilance<\/span><span class=\"NormalTextRun SCXW71732326 BCX0\" data-ccp-charstyle=\"Hyperlink\"> for Medical Devices in Mexico <\/span><\/span><\/a><\/span><span data-contrast=\"auto\">which\u00a0analyzes\u00a0in\u00a0depth\u00a0when\u00a0an\u00a0incident\u00a0should, and\u00a0should\u00a0not, be\u00a0reported.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Technovigilance Responsibilities for Distributors and Healthcare Professionals in Mexico<\/span><\/b><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">In addition to the MRH and manufacturer, distributors and healthcare professionals also carry explicit responsibilities under NOM\u2011240-SSA1. Distributors must immediately communicate any suspected adverse incidents to the MRH and support documentation collection, device retrieval, and corrective actions. Healthcare professionals, who often detect issues first, are obligated to report incidents promptly and accurately, ensuring that early warning signals are not overlooked.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Effective\u00a0technovigilance\u00a0depends on\u00a0strong\u00a0collaboration among all\u00a0parties involved: the manufacturer, MRH, distributors, and healthcare professionals.\u00a0A well\u2011coordinated communication chain ensures\u00a0timely\u00a0reporting,\u00a0accurate\u00a0evaluation, and rapid implementation of necessary preventive or corrective measures to protect patient safety.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Adverse Incident Reporting Timelines<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The MRH must adhere to strict reporting deadlines:<\/span><span data-ccp-props=\"{}\">\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;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\">Public health threat: Within 2 working days<\/span><span data-ccp-props=\"{}\">\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;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\">Death or serious health deterioration: Within\u00a010 days<\/span><span data-ccp-props=\"{}\">\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;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\">Other\u00a0adverse\u00a0incidents:\u00a0Within\u00a030\u00a0days<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">FAQs: Mexico\u00a0Technovigilance\u00a0and Adverse Incident Reporting<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol>\n<li><span data-contrast=\"auto\"> What is technovigilance in Mexico?<\/span><br \/>\n<span data-contrast=\"auto\">Technovigilance\u00a0is the post-market surveillance program for medical devices regulated by NOM-240-SSA1. It ensures device safety through systematic monitoring and incident reporting.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><span data-contrast=\"auto\"> Who is responsible for reporting adverse incidents to COFEPRIS?<\/span><br \/>\n<span data-contrast=\"auto\">The Mexican Registration Holder is primarily responsible for reporting adverse incidents. However, manufacturers, distributors, healthcare professionals, patients, and any individual involved with the medical device can also file a report with COFEPRIS.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><span data-contrast=\"auto\"> What are the timelines for reporting adverse incidents?<\/span><\/li>\n<\/ol>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" 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\">Public\u00a0health\u00a0threat: 2\u00a0working\u00a0days<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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;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\">Death or serious health deterioration:\u00a010 days<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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;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\">Other\u00a0adverse\u00a0incidents: 30\u00a0days<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"4\">\n<li><span data-contrast=\"auto\"> How do you report an adverse incident to COFEPRIS?<\/span><br \/>\n<span data-contrast=\"auto\">Reports can be submitted via hardcopy using the official format or through the COFEPRIS online platform.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"5\">\n<li><span data-contrast=\"auto\"> Why is the Registration Holder critical for compliance?<\/span><br \/>\n<span data-contrast=\"auto\">The MRH manages the technovigilance program, ensures timely reporting, and acts as the legal representative of the manufacturer in Mexico.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Adverse incident reporting is not only a regulatory obligation but a vital practice to ensure patient safety and\u00a0maintain\u00a0market authorization in Mexico. Manufacturers should\u00a0establish\u00a0robust communication with their MRH and implement proactive\u00a0technovigilance\u00a0strategies.\u00a0A strong and collaborative relationship among manufacturers, the MRH, distributors, and healthcare professionals is essential to ensure\u00a0accurate\u00a0reporting and rapid risk mitigation.\u00a0When in doubt, authorities encourage reporting rather than withholding information.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u202fIf you need support in your\u00a0Technovigilance\u00a0Unit,\u00a0notifications\u00a0and\/or reports, 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","protected":false},"excerpt":{"rendered":"<p>Introduction\u00a0 \u00a0 Technovigilance\u00a0in Mexico is a critical post-market surveillance activity that ensures medical devices\u00a0remain\u00a0safe and effective throughout their lifecycle. For\u00a0foreign\u00a0manufacturers entering the Mexican market, understanding adverse incident reporting and the role of the Mexican Registration Holder (MRH) is essential for compliance with NOM-240-SSA1\u00a0and COFEPRIS requirements.\u00a0 This article explains what constitutes an adverse incident, who\u00a0is responsible [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4216,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[381,390],"tags":[],"class_list":["post-4215","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cofepris","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>COFEPRIS Adverse Incident Reporting and MRH Responsibilities - Veraque Mexico<\/title>\n<meta name=\"description\" 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