{"id":66843,"date":"2026-02-16T18:36:00","date_gmt":"2026-02-16T13:06:00","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=66843"},"modified":"2026-02-17T11:54:06","modified_gmt":"2026-02-17T06:24:06","slug":"refurbished-medical-devices","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/16-02-2026\/refurbished-medical-devices","title":{"rendered":"Refurbished Medical Devices in India: Access vs. Regulation"},"content":{"rendered":"\n<p><strong>Syllabus: GS2\/Issues Related To Health<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Context<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The import of refurbished high-end medical equipment has major implications for healthcare access, industry policy, and patient safety.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What Are Refurbished Medical Devices?<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Refurbished medical devices are previously used systems that have been restored to their original operating specifications and resold at significantly lower prices.<\/li>\n\n\n\n<li>These are typically capital-intensive machines used in advanced diagnostics and surgery.<\/li>\n\n\n\n<li>Examples include <strong>MRI scanners (Magnetic Resonance Imaging); CT scanners (Computed Tomography); PET-CT systems (Positron Emission Tomography\u2013CT); <\/strong>Advanced endoscopy and laparoscopy units; and Robotic navigation and surgery systems;<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-background has-fixed-layout\" style=\"background-color:#ebecf0\"><tbody><tr><td colspan=\"3\"><strong>Why Does Cost Matters?<\/strong><\/td><\/tr><tr><td><strong>Equipment<\/strong><\/td><td><strong>New Price<\/strong><\/td><td><strong>Refurbished Price<\/strong><\/td><\/tr><tr><td>1.5T MRI<\/td><td>\u20b94\u20138 crore<\/td><td>\u20b91\u20133.5 crore<\/td><\/tr><tr><td>PET-CT<\/td><td>About \u20b920 crore<\/td><td>\u20b960 lakh\u2013\u20b93.5 crore<\/td><\/tr><tr><td>CT scanner<\/td><td>\u20b92\u20134 crore<\/td><td>\u20b920 lakh\u2013\u20b92.5 crore<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li>For<strong> hospitals in Tier-2 and Tier-3 cities,<\/strong> <strong>district centres, and standalone diagnostic facilities,<\/strong> these savings can determine whether advanced diagnostics are available locally at all.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Current Regulatory Landscape in India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>No Dedicated Regulatory Pathway: <\/strong>India currently lacks a specific regulatory framework governing refurbished devices under the <strong>Medical Devices Rules, 2017<\/strong>.<\/li>\n\n\n\n<li>In 2020, all medical devices were<strong> notified as \u2018drugs\u2019 under the Drugs and Cosmetics Act<\/strong>, expanding central oversight, but <strong>no specific licensing pathway<\/strong> was created for refurbished products.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How Imports Are Currently Allowed?<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Imports of used medical equipment are governed primarily under the <strong>Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016<\/strong>. Under <strong>amendments introduced in December 2022:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Certain high-end used devices may be imported.<\/li>\n\n\n\n<li>Prior permission is required from the MoEFCC.<\/li>\n\n\n\n<li>Maintenance history, quality assurance reports, and compliance documentation must be submitted.<\/li>\n\n\n\n<li>Technical input from the Central Drugs Standard Control Organisation (CDSCO) is required.<\/li>\n\n\n\n<li>Import authorisation from the Directorate General of Foreign Trade (DGFT) is mandatory.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Regulatory Issues: <\/strong>CDSCO, in January 2025, stated <strong>refurbished devices cannot be imported for sale or distribution<\/strong> because there is <strong>no licensing provision<\/strong> under the <strong>Medical Devices Rules.<\/strong><\/li>\n\n\n\n<li>However, in November 2025, a <strong>technical expert committee under MoEFCC cleared multiple refurbished devices,<\/strong> including CT scanners, MRI systems, and robotic surgical units<strong> for reuse. <\/strong>This created a legal inconsistency:\n<ul class=\"wp-block-list\">\n<li><strong>MoEFCC approval under waste rules;<\/strong><\/li>\n\n\n\n<li><strong>CDSCO prohibition under medical device laws;<\/strong><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Import Dependency:<\/strong> India continues to depend heavily on imports for high-end imaging technologies due to complex manufacturing requirements, including <strong>precision detectors, advanced software systems, and sophisticated supply chains.<\/strong>\n<ul class=\"wp-block-list\">\n<li>Refurbished equipment is <strong>typically sourced from developed markets such as the US, Germany, Japan, and the Netherlands,<\/strong> where hospitals upgrade equipment before its full functional life ends.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>New Policy Committee<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong>Department of Pharmaceuticals<\/strong> informed the Rajya Sabha that the <strong>Ministry of Health and Family Welfare<\/strong>, in February 2026, has <strong>constituted a committee<\/strong> to <strong>develop a formal policy on refurbished medical devices.<\/strong><\/li>\n\n\n\n<li>The committee aims to:\n<ul class=\"wp-block-list\">\n<li>define what qualifies as \u2018refurbished\u2019;<\/li>\n\n\n\n<li>develop methods to evaluate safety, performance, and remaining useful life;<\/li>\n\n\n\n<li>recommend guidance on waste disposal;<\/li>\n\n\n\n<li>examine regulatory alignment;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Stakeholder Perspectives<\/strong><\/h2>\n\n\n\n<p><strong>International Manufacturers (MTAI):<\/strong> The <strong>Medical Technology Association of India (MTAI)<\/strong>, representing over 50 international manufacturers, argues that:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A blanket ban would hurt affordability.<\/li>\n\n\n\n<li>India needs a<strong> globally aligned, time-bound policy.<\/strong><\/li>\n\n\n\n<li>Refurbished devices should be <strong>allowed only through original equipment manufacturers (OEMs)<\/strong> to ensure legal accountability, proper servicing, and patient safeguards.<\/li>\n\n\n\n<li>MTAI maintains that refurbished equipment:\n<ul class=\"wp-block-list\">\n<li>Expands access in smaller cities;<\/li>\n\n\n\n<li>Supports healthcare worker training goals;<\/li>\n\n\n\n<li>Aligns with India\u2019s export ambitions for healthcare professionals;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><strong>Domestic Manufacturers (AiMeD): <\/strong>The <strong>Association of Indian Medical Device Industry (AiMeD)<\/strong> strongly opposes relaxing restrictions without a robust framework aligned with international regulatory standards.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Their concerns include unknown usage histories, inconsistent performance, limited traceability, shorter remaining lifespan, and risk of India becoming a \u2018dumping ground\u2019.<\/li>\n\n\n\n<li><strong>AiMeD <\/strong>argues that legalising imports could undermine \u2018Make in India\u2019 initiatives and weaken preparedness during future health emergencies.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Way Ahead: What Happens Next?<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The government\u2019s policy committee will need to establish a clear legal definition, align environmental and medical regulations, create a<strong> licensing pathway under Medical Devices Rules<\/strong>, define quality, testing, and lifespan standards, and ensure transparency for buyers and patients.<\/li>\n\n\n\n<li>If crafted carefully, the framework <strong>could improve patient safety, expand affordable access, support domestic industry, and ensure regulatory coherence.<\/strong><\/li>\n\n\n\n<li>The outcome will <strong>shape India\u2019s diagnostic infrastructure<\/strong> and its <strong>long-term medical technology ambitions.<\/strong><\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/indianexpress.com\/article\/explained\/explained-health\/refurbished-medical-devices-india-global-vs-domestic-10530125\/\" target=\"_blank\" rel=\"noopener\">Source: IE<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong> Context <\/strong><\/p>\n<li class=\"ms-5\"> The import of refurbished high-end medical equipment has major implications for healthcare access, industry policy, and patient safety. <\/li>\n<p><\/p>\n<p><strong> What Are Refurbished Medical Devices? <\/strong><\/p>\n<li class=\"ms-5\"> Refurbished medical devices are previously used systems that have been restored to their original operating specifications and resold at significantly lower prices. <\/li>\n<li class=\"ms-5\"> These are typically capital-intensive machines used in advanced diagnostics and surgery. <\/li>\n<p><a href=\" https:\/\/www.nextias.com\/ca\/current-affairs\/16-02-2026\/refurbished-medical-devices \" 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More<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"class_list":["post-66843","post","type-post","status-publish","format-standard","hentry","category-current-affairs"],"acf":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/66843","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/comments?post=66843"}],"version-history":[{"count":4,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/66843\/revisions"}],"predecessor-version":[{"id":66851,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/66843\/revisions\/66851"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=66843"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=66843"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=66843"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}