{"id":83061,"date":"2026-08-25T18:05:25","date_gmt":"2026-08-25T12:35:25","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=83061"},"modified":"2026-08-25T18:06:02","modified_gmt":"2026-08-25T12:36:02","slug":"medical-device-rules-amendments","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/25-08-2026\/medical-device-rules-amendments","title":{"rendered":"India Proposes Medical Device Rule Changes To Boost Ease Of Business"},"content":{"rendered":"\n<p><strong>Syllabus: GS2\/ Health\/ Governance<\/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 Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to promote ease of doing business.\u00a0<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Key Proposed Amendments<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Simplification of Outsourced Sterilisation (Amendment to Rule 44): <\/strong>Manufacturers outsourcing sterilisation to a facility, holding a valid licence under the Medical Devices Rules, 2017, will <strong>no longer require a separate loan licence<\/strong> for the sterilisation activity.\n<ul class=\"wp-block-list\">\n<li><strong>Traceability will be retained:<\/strong> manufacturers must mention the licence number of the sterilisation facility on the medical device label.<\/li>\n\n\n\n<li><strong>A six-month transition period <\/strong>has been provided to allow companies to modify labels, packaging and related processes.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Standardised Testing Fees: <\/strong>A <strong>Ninth Schedule<\/strong> is proposed to prescribe uniform fees for medical device testing laboratories. It will <strong>reduce variations and uncertainty<\/strong> in testing charges.<\/li>\n\n\n\n<li><strong>Recognition of the European Union (Amendment to Rule 63): <\/strong>The European Union (EU) will be added to the list of <strong>recognised stringent regulatory jurisdictions<\/strong> for waiving clinical investigation requirements for certain medical devices without predicate devices in India.\n<ul class=\"wp-block-list\">\n<li>The existing list includes the <strong>US, UK, Australia, Canada and Japan.<\/strong><\/li>\n\n\n\n<li>Medical devices approved in the EU that meet the eligibility conditions can benefit from the waiver provisions in India.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Significance&nbsp;<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reduces unnecessary licensing<\/strong> and compliance requirements.<\/li>\n\n\n\n<li><strong>Enables quicker availability<\/strong> of eligible and innovative medical devices.<\/li>\n\n\n\n<li><strong>Standardised testing fees<\/strong> make compliance costs more predictable.<\/li>\n\n\n\n<li>Brings India&#8217;s regulatory framework closer to <strong>global practices.<\/strong><\/li>\n\n\n\n<li>A simpler and more predictable regulatory environment can <strong>promote investment and innovation<\/strong> in India&#8217;s medical-device industry.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Medical Devices Sector in India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The medical devices sector covers a wide range of products, including <strong>diagnostic equipment,<\/strong> imaging devices such as <strong>MRI and CT scanners, implants, surgical instruments,<\/strong> patient-monitoring equipment and in-vitro diagnostic (IVD) devices.<\/li>\n\n\n\n<li>India\u2019s medical devices market is projected to grow steadily from <strong>US$ 15.2 billion in 2025<\/strong> to US$ 50.1 billion by 2030.<\/li>\n\n\n\n<li><strong>FDI inflow<\/strong> in the medical and surgical appliances sector between April 2000- December 2025 stood at <strong>US$ 4.24 billion.<\/strong><\/li>\n<\/ul>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img data-dominant-color=\"ddd5d3\" data-has-transparency=\"false\" loading=\"lazy\" decoding=\"async\" width=\"628\" height=\"296\" src=\"https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/08\/image-229.png\" alt=\"medical devices sector in india\" class=\"not-transparent wp-image-83062\" style=\"--dominant-color: #ddd5d3; aspect-ratio:2.121680831969593;width:610px;height:auto\" srcset=\"https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/08\/image-229.png 628w, https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/08\/image-229-300x141.png 300w\" sizes=\"auto, (max-width: 628px) 100vw, 628px\" \/><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><strong>Government Initiatives<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>The National Medical Devices Policy 2023 <\/strong>supports India\u2019s medical devices sector through regulatory streamlining, infrastructure, R&amp;D, and investment promotion, boosting competitiveness and exports.<\/li>\n\n\n\n<li><strong>100% FDI is allowed<\/strong> in the medical devices sector in India. Categories such as equipment and instruments, consumables and implants attract the most FDI.<\/li>\n\n\n\n<li><strong>The Scheme for Promotion of Medical Devices Parks<\/strong> aims to create common infrastructure and testing facilities for increased competitiveness and cost reduction of medical device units through optimisation of resources.\n<ul class=\"wp-block-list\">\n<li>Under the scheme, three parks have been approved and are at an advanced stage of development in <strong>Greater Noida (Uttar Pradesh), Ujjain (Madhya Pradesh) and Kanchipuram (Tamil Nadu).<\/strong>\u00a0<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Regulatory Framework: <\/strong>The <strong>Drugs and Cosmetics Act, 1940,<\/strong> and the Medical Devices Rules, 2017, control the import, manufacture, sale, and distribution of medical devices.<\/li>\n\n\n\n<li><strong>In 2026<\/strong>, the India\u2013EU FTA unlocked access to a <strong>US$ 572.3 billion EU pharma and MedTech market,<\/strong> boosting export opportunities for Indian medical devices through liberalised tariffs and preferential market access<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Challenges with Medical Devices Sector in India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>India still imports around 70\u201380% of its medical devices,<\/strong> particularly high-end and technologically advanced equipment.<\/li>\n\n\n\n<li><strong>Limited domestic manufacturing<\/strong> of critical components and raw materials.<\/li>\n\n\n\n<li><strong>High cost of R&amp;D and clinical investigations<\/strong>, which can discourage innovation.<\/li>\n\n\n\n<li><strong>Inadequate testing and manufacturing infrastructure<\/strong> in some segments.<\/li>\n\n\n\n<li>There is a <strong>shortage<\/strong> of specialised, industry-ready <strong>skilled manpower.<\/strong><\/li>\n\n\n\n<li><strong>Limited integration<\/strong> of Indian manufacturers into global value chains.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Way Ahead<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>India should reduce its import dependence on medical devices by promoting domestic manufacturing, R&amp;D, innovation and medical-device infrastructure.<\/li>\n\n\n\n<li>A predictable and streamlined regulatory framework, while ensuring quality, safety and traceability, can attract investment and position India as a global medical-device manufacturing hub.<\/li>\n<\/ul>\n\n\n\n<p><strong>Source: <\/strong><a href=\"https:\/\/www.thehindu.com\/news\/national\/medical-device-rules-eased-for-outsourced-sterilisation-eu-added-to-stringent-regulatory-jurisdictions\/article7138\" target=\"_blank\" rel=\"noopener\"><strong>TH<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong> Context <\/strong><\/p>\n<li class=\"ms-5\"> The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to promote ease of doing business.\u00a0 <\/li>\n<p><\/p>\n<p><strong>  Key Proposed Amendments <\/strong><\/p>\n<li class=\"ms-5\"> Simplification of Outsourced Sterilisation (Amendment to Rule 44): Manufacturers outsourcing sterilisation to a facility, holding a valid licence under the Medical Devices Rules, 2017, will no longer require a separate loan licence for the sterilisation activity. <\/li>\n<li class=\"ms-5\"> Traceability will be retained: manufacturers must mention the licence number of the sterilisation facility on the medical device label. <\/li>\n<p><a href=\"https:\/\/www.nextias.com\/ca\/current-affairs\/25-08-2026\/medical-device-rules-amendments\" class=\"btn btn-primary btn-sm float-end\">Read More<\/a><\/p>\n","protected":false},"author":15,"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-83061","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\/83061","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\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/comments?post=83061"}],"version-history":[{"count":2,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/83061\/revisions"}],"predecessor-version":[{"id":83064,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/83061\/revisions\/83064"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=83061"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=83061"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=83061"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}