{"id":1691,"date":"2021-03-05T18:57:23","date_gmt":"2021-03-05T18:57:23","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1691"},"modified":"2025-04-07T20:40:51","modified_gmt":"2025-04-07T20:40:51","slug":"mdsap-and-how-to-use-it-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/mdsap-and-how-to-use-it-in-mexico\/","title":{"rendered":"MDSAP and how to use it in Mexico"},"content":{"rendered":"<h2><b><span data-contrast=\"auto\">MDSAP and its implementation\u00a0<\/span><\/b><b><span data-contrast=\"auto\">for Sanitary Registration of Medical Devices in Mexico with Equivalency Agreements<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h2>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Since 2012\u00a0<\/span><span data-contrast=\"auto\">t<\/span><span data-contrast=\"auto\">he\u00a0<\/span><a href=\"http:\/\/www.imdrf.org\/workitems\/wi-mdsap.asp\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">International Medical Device Regulators Forum<\/span><\/a><span data-contrast=\"auto\">\u00a0(IMDRF) has been working in a project called\u00a0<\/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\">Medical Device Single Audit Program<\/span><\/a><span data-contrast=\"auto\">\u00a0(MDSAP)<\/span><span data-contrast=\"auto\">\u00a0with the aim of\u00a0<\/span><span data-contrast=\"auto\">conduct<\/span><span data-contrast=\"auto\">ing<\/span><span data-contrast=\"auto\">\u00a0a single regulatory audit of\u00a0 medical device manufacturer<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\">\u00a0that satisfies the relevant requirements of the regulatory authorities participating in the program<\/span><span data-contrast=\"auto\">. The MDSAP\u00a0<\/span><span data-contrast=\"auto\">must be<\/span><span data-contrast=\"auto\">\u00a0performed by a recognized\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/media\/142182\/download\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Auditing Organization<\/span><\/a><span data-contrast=\"auto\">\u00a0(AO).<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">The MDSAP working group is formed by international partners divided into Members, Official Observers and Affiliate Members:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">MDSAP Members<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Therapeutic Goods Administration of Australia<\/span><span data-contrast=\"auto\">\u00a0(TGA)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Brazil\u2019s<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Ag\u00eancia<\/span><span data-contrast=\"auto\">\u00a0Nacional de\u00a0<\/span><span data-contrast=\"auto\">Vigil\u00e2ncia<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Sanit\u00e1ria<\/span><span data-contrast=\"auto\">\u00a0(ANVISA)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Health Canada<\/span><span data-contrast=\"auto\">\u00a0(HC)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Japan\u2019s Ministry of Health,\u00a0<\/span><span data-contrast=\"auto\">Labour<\/span><span data-contrast=\"auto\">\u00a0and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency<\/span><span data-contrast=\"auto\">\u00a0(MHLW &amp; PMDA)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">U.S. Food and Drug Administration<\/span><span data-contrast=\"auto\">\u00a0(FDA)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">MDSAP Official Observers:<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)\u00a0<\/span><span data-contrast=\"auto\">Programme<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">European Union (EU)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"auto\">MDSAP Affiliate Members:\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Argentina&#8217;s National Administration of Drugs, Foods and Medical Devices (ANMAT)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Republic of Korea&#8217;s Ministry of Food and Drug Safety<\/span><span data-contrast=\"auto\">\u00a0(MFDS)<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">On 2017, after 3 years\u00a0<\/span><span data-contrast=\"auto\">the viability of the MDSAP<\/span><span data-contrast=\"auto\">\u00a0pilot was confirmed by the\u00a0<\/span><a href=\"https:\/\/fda.report\/media\/106289\/MDSAP-Final-Pilot-Report-July-2017.pdf\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">MDSAP\u00a0<\/span><span data-contrast=\"none\">Final\u00a0<\/span><span data-contrast=\"none\">Pilot Report<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Since then,\u00a0<\/span><span data-contrast=\"auto\">FDA continue<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\">\u00a0accept<\/span><span data-contrast=\"auto\">ing<\/span><span data-contrast=\"auto\">\u00a0MDSAP audit reports as a substitute for routine Agency inspections<\/span><span data-contrast=\"auto\">\u00a0(Establishment Inspections).\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">In<\/span><span data-contrast=\"auto\">\u00a02019 Health Canada switched to MDSAP and SCC is no longer issuing accreditation to Authorized Registrar<\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Even when\u00a0<\/span><span data-contrast=\"auto\">MDSAP\u00a0<\/span><span data-contrast=\"auto\">is currently\u00a0<\/span><a href=\"https:\/\/www.bsigroup.com\/en-GB\/medical-devices\/our-services\/Medical-Device-Single-Audit-Program\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">focused<\/span><\/a><span data-contrast=\"auto\">\u00a0on\u00a0<\/span><span data-contrast=\"auto\">easily\u00a0<\/span><span data-contrast=\"auto\">allow<\/span><span data-contrast=\"auto\">\u00a0medical device manufacturers\u00a0<\/span><span data-contrast=\"auto\">to market their products in<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">the\u00a0<\/span><span data-contrast=\"auto\">countries<\/span><span data-contrast=\"auto\">\u00a0of MDSAP Members,<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">i<\/span><span data-contrast=\"auto\">t\u2019s<\/span><span data-contrast=\"auto\">\u00a0global approach makes\u00a0<\/span><span data-contrast=\"auto\">it\u00a0<\/span><span data-contrast=\"auto\">useful for obtaining marketing authorization in<\/span><span data-contrast=\"auto\">\u00a0other countries such as<\/span><span data-contrast=\"auto\">\u00a0Mexico by<\/span><span data-contrast=\"auto\">\u00a0using<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/new-expedited-timelines-for-medical-device-registration-approvals-in-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Equivalency Agreement<\/span><\/a><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">Because the Equivalency Agreements<\/span><span data-contrast=\"auto\">\u00a0in Mexico<\/span><span data-contrast=\"auto\">\u00a0have not been updated<\/span><span data-contrast=\"auto\">\u00a0for MDSAP purposes<\/span><span data-contrast=\"auto\">,<\/span><span data-contrast=\"auto\">\u00a0COFEPRIS<\/span><span data-contrast=\"auto\">\u00a0included\u00a0<\/span><span data-contrast=\"auto\">it<\/span><span data-contrast=\"auto\">\u00a0in a<\/span><span data-contrast=\"auto\">\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/mx\/good-manufacturing-practices-guide-for-mexico\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">guide\u00a0<\/span><span data-contrast=\"none\">issued in 2020<\/span><\/a><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">for Good Manufacturing Practices and equivalent documents.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">For medical\u00a0<\/span><span data-contrast=\"auto\">devices<\/span><span data-contrast=\"auto\">\u00a0already approved in the USA\u00a0<\/span><span data-contrast=\"auto\">the following documents are<\/span><span data-contrast=\"auto\">\u00a0considered as equivalent to\u00a0<\/span><span data-contrast=\"auto\">t<\/span><span data-contrast=\"auto\">he\u00a0<\/span><span data-contrast=\"auto\">Establishment Inspection Report (EIR)<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">for\u00a0<\/span><span data-contrast=\"auto\">requests<\/span><span data-contrast=\"auto\">\u00a0submitted<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">through the<\/span><span data-contrast=\"auto\">\u00a0FDA Equivalency Agreement<\/span><span data-contrast=\"auto\">:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">M<\/span><span data-contrast=\"auto\">edical devices Class I FDA: Last inspection report issued by MDSAP<\/span><\/li>\n<li><span data-contrast=\"auto\">M<\/span><span data-contrast=\"auto\">edical devices Class II FDA with 510(k): ISO 13485 certificate (current version) issued by organism certified by MDSAP<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">On the other hand, the following d<\/span><span data-contrast=\"auto\">ocuments<\/span><span data-contrast=\"auto\">\u00a0are<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">considered <\/span><span data-contrast=\"auto\">equivalent<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">to <\/span><span data-contrast=\"auto\">the<\/span><span data-contrast=\"auto\">\u00a0Good Manufacturing Practices (<\/span><span data-contrast=\"auto\">GMP<\/span><span data-contrast=\"auto\">)<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">for<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">class II, III and IV\u00a0<\/span><span data-contrast=\"auto\">products\u00a0<\/span><span data-contrast=\"auto\">submitted\u00a0<\/span><span data-contrast=\"auto\">through the\u00a0<\/span><span data-contrast=\"auto\">Hea<\/span><span data-contrast=\"auto\">l<\/span><span data-contrast=\"auto\">th Canada<\/span><span data-contrast=\"auto\">\u00a0(HC)<\/span><span data-contrast=\"auto\">\u00a0Equivalency Agreement\u00a0<\/span><span data-contrast=\"auto\">path<\/span><span data-contrast=\"auto\">:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">ISO 13485 certificate (current version) issued by organism certified by MDSAP.\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">ISO 17021 certificate issued by the same organism certified by MDSAP who issues the ISO 13485 certificate submitted.\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">The organism (Registrar) issuing both certificates must be listed as certified by MSDA<\/span><span data-contrast=\"auto\">P<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span class=\"TextRun SCXW120407731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120407731 BCX0\">Recently, <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">a<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">n<\/span> <\/span><a class=\"Hyperlink SCXW120407731 BCX0\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5752433&amp;fecha=20\/03\/2025#gsc.tab=0\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW120407731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW120407731 BCX0\" data-ccp-charstyle=\"Hyperlink\">agreement was published in the Official Mexican Diary<\/span> <span class=\"NormalTextRun SCXW120407731 BCX0\" data-ccp-charstyle=\"Hyperlink\">on March <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\" data-ccp-charstyle=\"Hyperlink\">20<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\" data-ccp-charstyle=\"Hyperlink\">,<\/span> <span class=\"NormalTextRun SCXW120407731 BCX0\" data-ccp-charstyle=\"Hyperlink\">2025<\/span><\/span><\/a><span class=\"TextRun SCXW120407731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120407731 BCX0\">,<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> regarding COFEPRIS criteria for<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> do<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">cume<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">nts that guarantee GMP.<\/span> <span class=\"NormalTextRun SCXW120407731 BCX0\">According to this announcement, the MDSAP certificate will <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">continue to<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> be recognized as an equivalent to GMP<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">s<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> for new registrations, renewals, and modifications of sanitary registr<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">ations<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">.<em> This recognition applies <\/em><\/span><em><span class=\"NormalTextRun SCXW120407731 BCX0\">solely <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">to products manufactured <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">outside<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> the<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> Mexican territory<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">,<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> or <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">to <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">manufacturers <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">established<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> in <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">the <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">national territory<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\"> s<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">ubcontracte<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">d by the <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">foreign <\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">legal manufacturer of the medical device<\/span><span class=\"NormalTextRun SCXW120407731 BCX0\">.<\/span><\/em><\/span><em><span class=\"EOP SCXW120407731 BCX0\" data-ccp-props=\"{&quot;335557856&quot;:16777215,&quot;335559739&quot;:216}\">\u00a0<\/span><\/em><\/p>\n<p>&nbsp;<\/p>\n<p>It is important to note that the validity and application of the contents of this announcement rely solely on COFEPRIS\u2019 criteria. We will closely monitor any further developments related to this new announcement.<\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">If you have any questions regarding MDSAP and its validity in Mexico to obtain Sanitary Registrations for Medical Devices using the\u00a0<\/span><span data-contrast=\"auto\">fast track<\/span><span data-contrast=\"auto\">\u00a0process known as Equivalency Agreements please contact\u00a0<\/span><span data-contrast=\"auto\">us at <a href=\"mailto:contact@veraqueconsulting.com\" target=\"_blank\" rel=\"noopener\">contact@veraqueconsulting.com<\/a>.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>MDSAP and its implementation\u00a0for Sanitary Registration of Medical Devices in Mexico with Equivalency Agreements\u00a0 &nbsp; Since 2012\u00a0the\u00a0International Medical Device Regulators Forum\u00a0(IMDRF) has been working in a project called\u00a0Medical Device Single Audit Program\u00a0(MDSAP)\u00a0with the aim of\u00a0conducting\u00a0a single regulatory audit of\u00a0 medical device manufacturers\u00a0that satisfies the relevant requirements of the regulatory authorities participating in the program. The [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1692,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[390],"tags":[],"class_list":["post-1691","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MDSAP and how to use it in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Find more details about how to use the Medical Device Single Audit in Mexico for Medical Devices. 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