{"id":1110,"date":"2021-11-19T06:54:12","date_gmt":"2021-11-19T06:54:12","guid":{"rendered":"http:\/\/kgscert.com\/demo\/?page_id=1110"},"modified":"2021-11-19T07:10:42","modified_gmt":"2021-11-19T07:10:42","slug":"iatf-16949-certification-2-2-2-2-2-2-3","status":"publish","type":"page","link":"https:\/\/kgscert.com\/index.php\/iatf-16949-certification-2-2-2-2-2-2-3\/","title":{"rendered":"MDA Approved Assessments &#8211; Full Conformity Assessment"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1110\" class=\"elementor elementor-1110\">\n\t\t\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-top-section elementor-element elementor-element-2d55d78 elementor-section-height-min-height cert-cover elementor-section-boxed elementor-section-height-default elementor-section-items-middle jltma-glass-effect-no\" data-id=\"2d55d78\" data-element_type=\"section\" id=\"cert-cover\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3edaee0 jltma-glass-effect-no\" data-id=\"3edaee0\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-37a2f9e jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"37a2f9e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.20.0 - 26-03-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><p class=\"elementor-heading-title elementor-size-default\">Certification - Medical Devices<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-top-section elementor-element elementor-element-6cf836d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6cf836d\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;mountains&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" opacity=\"0.33\" d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-12457c9 jltma-glass-effect-no\" data-id=\"12457c9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-311c580f jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"311c580f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">MDA Approved Assessments<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-372365c jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"372365c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">CERTIFICATION<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b22c904 jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"5b22c904\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Full Conformity Assessment<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-inner-section elementor-element elementor-element-52811f5 elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"52811f5\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-146f3b5 jltma-glass-effect-no\" data-id=\"146f3b5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-76ef051 elementor-mobile-align-center jltma-glass-effect-no elementor-widget elementor-widget-button\" data-id=\"76ef051\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/kgscert.com\/\/index.php\/verify-certificate\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Verify Certificate<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4173180 jltma-glass-effect-no\" data-id=\"4173180\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dc4550b elementor-mobile-align-center jltma-glass-effect-no elementor-widget elementor-widget-button\" data-id=\"dc4550b\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/kgscert.com\/\/index.php\/quotation\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Request A QOUTE<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ebb30d2 jltma-glass-effect-no\" data-id=\"ebb30d2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-35054d71 jltma-glass-effect-no elementor-widget elementor-widget-image\" data-id=\"35054d71\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.20.0 - 26-03-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"605\" src=\"https:\/\/kgscert.com\/wp-content\/uploads\/2021\/11\/medical-1.jpg\" class=\"attachment-full size-full wp-image-1052\" alt=\"\" srcset=\"https:\/\/kgscert.com\/wp-content\/uploads\/2021\/11\/medical-1.jpg 1000w, https:\/\/kgscert.com\/wp-content\/uploads\/2021\/11\/medical-1-300x182.jpg 300w, https:\/\/kgscert.com\/wp-content\/uploads\/2021\/11\/medical-1-768x465.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-top-section elementor-element elementor-element-1b493a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"1b493a3\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3cadfd6 jltma-glass-effect-no\" data-id=\"3cadfd6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-inner-section elementor-element elementor-element-cdb7345 elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"cdb7345\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-6995598 jltma-glass-effect-no\" data-id=\"6995598\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-03084e7 jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"03084e7\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">What is Full Conformity Assessment?<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8c5a1b jltma-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"b8c5a1b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.20.0 - 26-03-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Full Conformity Assessment is an assessment of the level of compliance of a medical device to the requirements specific to the device as well as to the requirements specified by the Medical Device Authority (MDA) of Malaysia prior to placement of the device in the Malaysian market.<\/p><p>Full Conformity Assessment is carried out for medical devices that are intended to be registered with the Malaysian Medical Device Authority by Local Manufacturers of those devices or by the Local Authorised Representative of the foreign manufacturer of those devices. Registration of medical devices with MDA is done online via the Medical Device Centralised Online Application System (MeDC@St).<\/p><p>The Full Conformity Assessment is a very comprehensive method of assessment of a medical device equivalent to a CE mark assessment. MDA approved conformity assessment of medical devices can only be carried out by Conformity Assessment Bodies (CABs) that have been approved by MDA as per Section 10 of the Malaysia Medical Device Act 2012 (Act 737).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ma_el_bg_slider elementor-section elementor-top-section elementor-element elementor-element-5e896f22 elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"5e896f22\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ma_el_bg_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1774e05b jltma-glass-effect-no\" data-id=\"1774e05b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1fc2e33a jltma-glass-effect-no elementor-widget elementor-widget-ma-tabs\" data-id=\"1fc2e33a\" data-element_type=\"widget\" data-widget_type=\"ma-tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\n\t\t<div id=\"jltma--advance-tabs-1fc2e33a\" class=\"jltma--advance-tab two \" data-tab-effect=\"click\" data-tabs>\n\n\t\t\t\n\t\t\t\t<ul class=\"jltma--advance-tab-nav\">\n\t\t\t\t\t\t\t\t\t\t\t<li class=\"active\" data-tab data-tab-id=\"jltma-tab-1fc2e33a0\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"jltma--tab-title\">\n\t\t\t\t\t\t\t\tPre-requisite for Full Conformity Assessment?\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t<li class=\"\" data-tab data-tab-id=\"jltma-tab-1fc2e33a1\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"jltma--tab-title\">\n\t\t\t\t\t\t\t\tHow is a medical device eligible for Full Conformity Assessment?\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t<li class=\"\" data-tab data-tab-id=\"jltma-tab-1fc2e33a2\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"jltma--tab-title\">\n\t\t\t\t\t\t\t\tWhat about Class A medical devices?\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t<li class=\"\" data-tab data-tab-id=\"jltma-tab-1fc2e33a3\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"jltma--tab-title\">\n\t\t\t\t\t\t\t\tWhat is needed to be submitted for Full Conformity Assessment?\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t<\/ul>\n\n\t\t\t\t\n\t\t\t\t<div class=\"tab-content\">\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"jltma-tab-1fc2e33a0\" class=\"jltma--advance-tab-content tab-pane active\">\n\t\t\t\t\t\t\t<p><strong>Pre-requisite for Full Conformity Assessment?<\/strong><\/p><p>Prior to engaging KGS to carry out Product Verification for a medical device:<\/p><ul><li>The Local Manufacturer shall have a valid ISO 13485 Certificate<\/li><li>The Local Authorised Representative shall have a valid GDPMD certificate<\/li><li>Both the Local Manufacturer and Local Authorised Representative shall have valid establishment license issued by the Malaysian Medical Device Authority<\/li><\/ul>\t\t\t\t\t\t<\/div><!-- jltma--advance-tab-content -->\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"jltma-tab-1fc2e33a1\" class=\"jltma--advance-tab-content tab-pane \">\n\t\t\t\t\t\t\t<p><strong>How is a medical device eligible for Full Conformity Assessment?<\/strong><\/p><p>For a device to be eligible to proceed for Full Conformity Assessment, the following criteria shall be satisfied:<\/p><ul><li>The medical device is not having pre-market approval or has not been subjected to conformity assessment by a recognized foreign regulatory authority or notified body as specified in the Table 1 of the MDA Circular 2\/2014.<\/li><li>The medical device shall be of Class B, C or D<\/li><\/ul>\t\t\t\t\t\t<\/div><!-- jltma--advance-tab-content -->\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"jltma-tab-1fc2e33a2\" class=\"jltma--advance-tab-content tab-pane \">\n\t\t\t\t\t\t\t<p><strong>What about Class A medical devices?<\/strong><\/p><p>Class A medical devices are exempted from conformity assessment procedures as per the Medical Device (Exemption) Order 2016, hence, can be registered with by MDA directly via the Medical Device Centralised Online Application System (MeDC@St).<\/p>\t\t\t\t\t\t<\/div><!-- jltma--advance-tab-content -->\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"jltma-tab-1fc2e33a3\" class=\"jltma--advance-tab-content tab-pane \">\n\t\t\t\t\t\t\t<p><strong>What is needed to be submitted for Full Conformity Assessment?<\/strong><\/p><p>Full conformity Assessment in Malaysia is similar to CE certification or US FDA premarket approval application. No predicate device or prior approval can be used as a leverage for this approval or to follow a simplified registration process. In a Full Conformity Assessment, a thorough scientific and regulatory review is conducted to evaluate the safety and effectiveness of medical devices, regardless of risk classification. The following will be assessed comprehensively:<\/p><ul><li><strong>Medical Device Quality management system (MDQMS): <\/strong><\/li><\/ul><p>Consideration will be given to any relevant existing certification and, if not satisfied, KGS may carry out an on-site audit of the manufacturer\u2019s facility. Criteria for acceptance of existing certification shall include the following:<\/p><ol><li>QMS certificate issued by MDA registered CAB;<\/li><li>QMS certificate issued by any notified body listed in New Approach Notified and Designated (NANDO);<\/li><li>QMS certificate issued by certification bodies from reference regulatory countries (US, Canada, Australia, Japan, EU);<\/li><\/ol><ul><li><strong>Post-market surveillance system (PMS): <\/strong><\/li><\/ul><p>To ensure a PMS is established, maintained and implemented by the establishment. The following processes shall be documented, maintained and implemented by the establishment:<\/p><ol><li>complaint handling;<\/li><li>distribution records;<\/li><li>mandatory problem\/adverse event reporting;<\/li><li>field corrective action; and<\/li><li>\u00a0<\/li><\/ol><ul><li><strong>Technical documentation:<\/strong><\/li><\/ul><p>A complete Common Submission Dossier Template (CSDT) must be established by the manufacturer. No abridged version will be accepted. Each and every test report and clinical evaluation reports must be made available and submitted when requested, for thorough evaluation. The adequacy of the documented evidence is determined in support of the manufacturer\u2019s declaration of conformity to the EPSP through a review of the CSDT and technical documentation.<\/p><ul><li><strong>Declaration of conformity: <\/strong><\/li><\/ul><p>Medical Devices manufacturers shall attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance (EPSP) and other requirements of Act 737 and the subsidiary regulations under it, documented in a written \u2018Declaration of Conformity\u2019 (DOC).<\/p>\t\t\t\t\t\t<\/div><!-- jltma--advance-tab-content -->\n\t\t\t\t\t\t\t\t\t<\/div> <!-- tab-content -->\n\n\n\t\t\t\t\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Certification &#8211; Medical Devices MDA Approved Assessments CERTIFICATION Full Conformity Assessment Verify Certificate Request A QOUTE What is Full Conformity Assessment? Full Conformity Assessment is an assessment of the level of compliance of a medical device to the requirements specific to the device as well as to the requirements specified by the Medical Device Authority [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"_links":{"self":[{"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/pages\/1110"}],"collection":[{"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/comments?post=1110"}],"version-history":[{"count":0,"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/pages\/1110\/revisions"}],"wp:attachment":[{"href":"https:\/\/kgscert.com\/index.php\/wp-json\/wp\/v2\/media?parent=1110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}