{"id":660,"date":"2020-02-05T14:57:05","date_gmt":"2020-02-05T14:57:05","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=660"},"modified":"2025-04-01T15:59:16","modified_gmt":"2025-04-01T15:59:16","slug":"good-manufacturing-practices-guide-for-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/good-manufacturing-practices-guide-for-mexico\/","title":{"rendered":"Good Manufacturing Practices Guide for Mexico"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignnone wp-image-48\" role=\"img\" src=\"https:\/\/veraqueconsulting.com\/mx\/wp-content\/uploads\/sites\/3\/2019\/11\/dossier-1.svg\" alt=\"Good Manufacturing Practices Guide for Mexico\" width=\"133\" height=\"125\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">Last March the 20<\/span><span data-contrast=\"none\">th<\/span><span data-contrast=\"none\"> 2025, <\/span><a href=\"https:\/\/www.gob.mx\/cofepris\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">COFEPRIS<\/span><\/a><span data-contrast=\"none\"> updated its Guidelines for submitting documents that guarantee Good Manufacturing Practices (<\/span><b><span data-contrast=\"none\">GMP<\/span><\/b><span data-contrast=\"none\">).<\/span> <a href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5752433&amp;fecha=20\/03\/2025#gsc.tab=0\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">The agreement published in the Official Mexican Diary<\/span><\/a><span data-contrast=\"auto\"> describes the criteria to evaluate the good manufacturing practices certificates or equivalent documents <\/span><span data-contrast=\"none\">submitted when requesting, modifying or extending a medical device sanitary registration.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">In this review, we highlight the most important points included in this guideline.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">GMP\u2019s accepted by COFEPRIS<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">COFEPRIS accepts GMP certificates issued by:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"13\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">A Recognized Regulatory Authority (FDA, HC, MHLW, EMA, TGA, MFDS, MHPRA and Swissmedic).<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ol>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"13\" 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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">The Health Authority in the country where the product is manufactured.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Verification Inspections<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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=\"none\">You can get a GMP issued by COFEPRIS requesting a verification inspection by this authority. This option is useful when you do not have a valid GMP issued by any authority.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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=\"none\">The verification inspections are not eligible for devices that are considered <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#routes\" target=\"_blank\" rel=\"noopener\"><i><span data-contrast=\"none\">low risk<\/span><\/i><\/a><span data-contrast=\"none\"> or <\/span><a href=\"http:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5376857&amp;fecha=22\/12\/2014\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">not considered medical devices<\/span><\/a><span data-contrast=\"none\"> as well.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" 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=\"none\">Only one medical device line per request is valid for verification inspections for foreign manufacturers.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Validity of the GMP Certificate<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Any GMP submitted to COFEPRIS must meet the following conditions:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" 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=\"none\">Present the original document or notarized copy of the whole document, keeping the original in case COFEPRIS requests it for confirmation.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"10\" 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=\"none\">All GMPs must be legalized or apostilled in the same country where the authority issued the GMP certificate.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&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;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=\"none\">GMPs not issued physically or issued with electronic signature do not require to get apostille or being legalized but must indicate the access route. They might be verified on official sites when applicable.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"8\" 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=\"none\">The document must be valid upon submission to COFEPRIS.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&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;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=\"none\">The GMP certificate must remain valid upon the submission of the process. <\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"7\" 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=\"none\">If the CBPF or equivalent becomes invalid during the process of processing a sanitary registration, extension, or modification, this will not be an argument for <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#prevention\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">prevention<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">GMP certificates must include:<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ol>\n<li><span data-contrast=\"none\">Company name of the legal manufacturer.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Addresses of all manufacturing sites involved in the production of the medical device.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Expiration date. If not indicated, it is considered valid 30 months from the date of issuance.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Lines of production, products, medical devices or processes that are certified in the GMP.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Documents considered equivalent to a GMP certificate<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ol>\n<li><span data-contrast=\"none\">ISO 13485 certificate (current version) issued by a certified organization.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">MDSAP Audit Certificate, in accordance with the ISO 13485 standard.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Document certifying compliance with GMP, issued by a Recognized Regulatory Authority.\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">CE mark certificate issued by an authorized organism in the European Union.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Declaration of compliance with the GMP included in the Free Sale Certificate issued by a Recognized Regulatory Authority or, when applicable, by the Ministry of Health in the country of origin.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Documents that are not considered equivalent to a GMP certificate<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Certificate of Conformance.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Establishment Inspection Report (EIR) when a sanitary registration is requested through the <\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/#routes\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">standard process<\/span><\/a><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Documents considered as equivalent to the EIR for FDA <\/span><\/b><a href=\"http:\/\/dof.gob.mx\/nota_detalle.php?codigo=5164641&amp;fecha=26\/10\/2010\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Equivalency Agreement<\/span><\/b><\/a><b><span data-contrast=\"none\"> submissions<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li 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\"><span data-contrast=\"none\">For FDA approved class I medical devices: Last inspection report issued by an <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/cdrh-international-programs\/medical-device-single-audit-program-mdsap\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">MDSAP<\/span><\/a><span data-contrast=\"none\"> member.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li 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\"><span data-contrast=\"none\">For FDA approved class II medical devices with 510(k): ISO 13485 certificate (current version) issued by a MDSAP member.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Note<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">For FDA approved class II and III medical devices with PMA (Pre-Market Approval), there is no equivalent document and EIR must be presented.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Documents considered as equivalent to the GMP for Health Canada (HC) Equivalency Agreement route<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The following documents can be submitted to meet the COFEPRIS requirements:<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">ISO 13485 certificate (current version) issued by a MDSAP member.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">ISO 17021 certificate issued by the same MDSAP member that issued the ISO 13485.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\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;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">The organism (Registrar) issuing both certificates must be listed as a MDSAP member.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">To receive more updates about regulatory changes in Mexico please send us an email to <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">Also, check our <\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/mx\/guides\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">guidelines<\/span><\/b><\/a><b><span data-contrast=\"none\"> for further details and hints!<\/span><\/b><span data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Last March the 20th 2025, COFEPRIS updated its Guidelines for submitting documents that guarantee Good Manufacturing Practices (GMP). The agreement published in the Official Mexican Diary describes the criteria to evaluate the good manufacturing practices certificates or equivalent documents submitted when requesting, modifying or extending a medical device sanitary registration.\u00a0 \u00a0\u00a0 In this review, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":3917,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10,390],"tags":[13,11,12],"class_list":["post-660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gmp","category-mexico","tag-certificates","tag-gmp","tag-good-manufacturing-practices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Good Manufacturing Practices Guide for Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Check the latest requirements for Good Manufacturing Practices in Mexico. 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