{"id":6670,"date":"2026-05-28T17:38:03","date_gmt":"2026-05-28T12:08:03","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6670"},"modified":"2026-05-28T17:38:03","modified_gmt":"2026-05-28T12:08:03","slug":"standard-ivd-evaluation-protocols","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/sa-en\/standard-ivd-evaluation-protocols\/","title":{"rendered":"ICMR &#038; CDSCO Release 39 Standard IVD Evaluation Protocols"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6670\" class=\"elementor elementor-6670\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-606ce9a e-flex e-con-boxed e-con e-parent\" data-id=\"606ce9a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-234dd982 e-con-full e-flex e-con e-child\" data-id=\"234dd982\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2569e0e9 elementor-widget elementor-widget-heading\" data-id=\"2569e0e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ICMR &#038; CDSCO Release 39 Standard IVD Evaluation Protocols<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-487212e elementor-widget elementor-widget-text-editor\" data-id=\"487212e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly released a compendium of 39 standardized protocols for evaluating In-Vitro Diagnostics (IVDs). This landmark move aims to enhance the performance, reliability, and global competitiveness of diagnostic tools developed in India.<\/span><\/p><p><span style=\"font-weight: 400;\">Also, read <\/span><a href=\"https:\/\/operonstrategist.com\/ivd-manufacturing\/\"><span style=\"font-weight: 400;\">IVD manufacturing<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-73997e26 e-con-full e-flex e-con e-child\" data-id=\"73997e26\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3d97fd2e e-con-full e-flex e-con e-child\" data-id=\"3d97fd2e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5eda84a0 elementor-widget elementor-widget-heading\" data-id=\"5eda84a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-466907be elementor-widget elementor-widget-wpforms\" data-id=\"466907be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/sa-en\/wp-json\/wp\/v2\/posts\/6670\" data-token=\"42a4e871549e8c9e5c65553f88b5f58e\" data-token-time=\"1780001875\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Email Text Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6670\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-49d6382c e-flex e-con-boxed e-con e-parent\" data-id=\"49d6382c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1477ed50 elementor-widget elementor-widget-heading\" data-id=\"1477ed50\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Scope of the Protocols\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-780c1087 elementor-widget elementor-widget-text-editor\" data-id=\"780c1087\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The protocols cover the evaluation of diagnostic kits for a wide range of diseases, including:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tuberculosis<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Malaria<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dengue<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Chikungunya<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Zika Virus<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Typhoid Fever<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Respiratory Viruses<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Chandipura Virus<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nipah Virus<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e374a99 elementor-widget elementor-widget-heading\" data-id=\"e374a99\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Expert Insights\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b695b8 elementor-widget elementor-widget-text-editor\" data-id=\"2b695b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h5><span style=\"font-weight: 400;\">Dr. Rajiv Bahl, Director General, ICMR<\/span><\/h5><p><span style=\"font-weight: 400;\">Dr. Bahl emphasized the importance of robust regulatory mechanisms to match India\u2019s fast-growing diagnostic industry. He stated that standardized evaluation protocols and accredited laboratory networks are critical for timely validation and market readiness of new diagnostic kits.<\/span><\/p><h5><span style=\"font-weight: 400;\">Dr. Rajeev Singh Raghuvanshi, DCGI<\/span><\/h5><p><span style=\"font-weight: 400;\">Dr. Raghuvanshi highlighted the significance of ensuring quality and performance of IVDs both at pre- and post-market stages. He noted that this initiative marks the world\u2019s first collaboration between a national regulatory authority and a national research institute to jointly develop standardized IVD protocols. This effort will streamline evaluation, accelerate availability, and support India\u2019s vision of affordable, accessible, and quality healthcare for all.<\/span><\/p><p><span style=\"font-weight: 400;\">Global Significance<\/span><\/p><p><span style=\"font-weight: 400;\">The compendium sets minimum standards, acceptance criteria, and uniform testing methods for IVD evaluation. By strengthening the validation process, the initiative ensures faster access to high-quality diagnostic products, not only for India but also for global markets.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7dcaadd elementor-widget elementor-widget-heading\" data-id=\"7dcaadd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Role of Operon Strategist\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e747c7 elementor-widget elementor-widget-text-editor\" data-id=\"3e747c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As a trusted regulatory and compliance partner, <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> assists medical device and IVD manufacturers in navigating the evolving regulatory landscape. Our team supports companies with:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulatory documentation and compliance with CDSCO standards<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/ivd-manufacturing\/\"><span style=\"font-weight: 400;\">IVD manufacturing and licensing guidance<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Market-entry strategies with adherence to global quality benchmarks<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">End-to-end support in product development and validation processes<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Through our expertise, we help manufacturers align with these newly introduced protocols, ensuring faster approvals, smoother compliance, and enhanced market readiness.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly released a compendium of 39 standardized protocols for evaluating In-Vitro Diagnostics (IVDs). This landmark move aims to enhance the performance, reliability, and global competitiveness of diagnostic tools developed in India. Also, read IVD manufacturing talk to our experts [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6807,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[57],"tags":[],"class_list":["post-6670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco-category"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6670","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/comments?post=6670"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6670\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media\/6807"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media?parent=6670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/categories?post=6670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/tags?post=6670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}