{"id":5988,"date":"2026-04-10T11:52:18","date_gmt":"2026-04-10T11:52:18","guid":{"rendered":"https:\/\/operonstratstg.wpenginepowered.com\/?p=5988"},"modified":"2026-04-10T12:08:43","modified_gmt":"2026-04-10T12:08:43","slug":"parliamentary-panel-recommends-decentralisation-of-medical-device-approvals-in-india","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/om-en\/parliamentary-panel-recommends-decentralisation-of-medical-device-approvals-in-india\/","title":{"rendered":"Parliamentary Panel Recommends Decentralisation of Medical Device Approvals in India"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5988\" class=\"elementor elementor-5988\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9158dca e-flex e-con-boxed e-con e-parent\" data-id=\"9158dca\" 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-4be04d22 e-con-full e-flex e-con e-child\" data-id=\"4be04d22\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-253da9c0 elementor-widget elementor-widget-text-editor\" data-id=\"253da9c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tA Parliamentary Panel on Health and Family Welfare has proposed major reforms in India\u2019s medical device regulatory framework, aiming to reduce approval delays, improve efficiency, and strengthen the country\u2019s global competitiveness.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8af568b e-con-full e-flex e-con e-child\" data-id=\"8af568b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-519c446 elementor-widget elementor-widget-heading\" data-id=\"519c446\" 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\">Push for Decentralisation\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f6b3d9 elementor-widget elementor-widget-text-editor\" data-id=\"1f6b3d9\" 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>The panel has recommended decentralising approvals for all medical devices\u2014including imports and higher-risk Class C and D devices\u2014to State Drug Authorities, reducing dependency on the CDSCO. Read about <a href=\"https:\/\/operonstrategist.com\/cdsco-classification-for-medical-devices\/\">CDSCO classifications.<\/a><\/p><p>Currently, state authorities regulate drugs and low-risk devices (Class A\/B), while CDSCO oversees imports and high-risk devices. The panel believes this centralisation has created bottlenecks and slowed down approvals.<\/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-c2450f2 e-con-full e-flex e-con e-child\" data-id=\"c2450f2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3822e3b elementor-widget elementor-widget-heading\" data-id=\"3822e3b\" 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\">Concerns Over Approval Delays\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aa24207 elementor-widget elementor-widget-text-editor\" data-id=\"aa24207\" 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>The report highlighted critical inefficiencies in the current system:<\/p><ul><li>Around 62% of applications faced multiple query cycles<\/li><li>Over 250 import applications remained pending beyond 90 days. More about <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/cdsco-import-license\/\">CDSCO Import License<\/a><\/li><li>Even devices approved by global regulators experienced delays<\/li><\/ul><p><br \/>These issues were attributed to unclear submission requirements and an inefficient review process.<\/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-5c2957d e-con-full e-flex e-con e-child\" data-id=\"5c2957d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-121dd46 elementor-widget elementor-widget-heading\" data-id=\"121dd46\" 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\">Key Recommendations by the Panel\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6334457 elementor-widget elementor-widget-text-editor\" data-id=\"6334457\" 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>To streamline approvals and enhance transparency, the panel suggested:<\/p><ul><li>AI-assisted pre-submission validation in the MD Online portal<\/li><li>A \u201csingle comprehensive query\u201d system to avoid repeated queries<\/li><li>Creation of a dedicated facilitation cell to guide manufacturers under MDR 2017<\/li><li>Development of a unified National Regulatory Dashboard integrating central and state systems<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b9fc9f0 e-con-full e-flex e-con e-child\" data-id=\"b9fc9f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-265dded elementor-widget elementor-widget-heading\" data-id=\"265dded\" 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\">Self-Financing Regulatory System<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5042004 elementor-widget elementor-widget-text-editor\" data-id=\"5042004\" 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>The panel also proposed that CDSCO should become self-financing by utilising revenue generated from medical device licensing. A portion of these funds should be reinvested into:<\/p><ul><li>Digital infrastructure upgrades<\/li><li>Capacity building at both central and state levels<\/li><li>Real-time compliance monitoring systems<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d1bf93c e-con-full e-flex e-con e-child\" data-id=\"d1bf93c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f501084 elementor-widget elementor-widget-heading\" data-id=\"f501084\" 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-c1860cf elementor-widget elementor-widget-text-editor\" data-id=\"c1860cf\" 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>With evolving regulatory changes, companies will require expert guidance to stay compliant and competitive. <a href=\"https:\/\/operonstrategist.com\/\">Operon Strategist<\/a> can support medical device manufacturers through:<\/p><ul><li>Regulatory Strategy Planning: Aligning business models with decentralised approval pathways<\/li><li>Documentation &amp; Submission Support: Ensuring error-free applications to reduce query cycles<\/li><li>MDR 2017 Compliance: End-to-end assistance in meeting Indian regulatory requirements<\/li><li>Portal &amp; Process Navigation: Helping manufacturers efficiently manage CDSCO and state-level approvals<\/li><li>Market Entry Acceleration: Minimising delays and speeding up time-to-market<\/li><\/ul>\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>A Parliamentary Panel on Health and Family Welfare has proposed major reforms in India\u2019s medical device regulatory framework, aiming to reduce approval delays, improve efficiency, and strengthen the country\u2019s global competitiveness. Push for Decentralisation The panel has recommended decentralising approvals for all medical devices\u2014including imports and higher-risk Class C and D devices\u2014to State Drug Authorities, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":5989,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-5988","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-updates"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/5988","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/comments?post=5988"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/5988\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media\/5989"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media?parent=5988"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/categories?post=5988"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/tags?post=5988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}