{"id":8386,"date":"2025-08-20T03:13:32","date_gmt":"2025-08-20T03:13:32","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8386"},"modified":"2025-09-16T16:44:56","modified_gmt":"2025-09-16T16:44:56","slug":"post-approval-changes-for-medical-devices-in-india","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/","title":{"rendered":"Post-Approval Changes (PAC) for Medical Devices in India"},"content":{"rendered":"<p style=\"text-align: justify;\">In India, medical devices are strictly regulated under the Medical Device Rules, 2017, by the Central Drugs Standard Control Organization (CDSCO). When a device is approved, manufacturers and importers may seek modifications in licensing information over a period of time. These are called post-approval changes to medical devices, and they must meet regulatory procedures. Otherwise, the safety and performance of medical devices are at stake.<\/p>\n<p style=\"text-align: justify;\">This post explains medical devices post-approval changes, differences between major and minor changes, and how to get approval from the CDSCO.<\/p>\n<p>&nbsp;<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#What_Are_Post-Approval_Changes_for_Medical_Devices_in_India\" >What Are Post-Approval Changes for Medical Devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#Types_of_Post-Approval_Changes_for_Medical_Devices\" >Types of Post-Approval Changes for Medical Devices<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#1_Major_Changes_Require_CDSCO_Prior_Approval\" >1. Major Changes (Require CDSCO Prior Approval)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#2_Minor_Changes_Require_CDSCO_Notification_Only\" >2. Minor Changes (Require CDSCO Notification Only)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#CDSCO_Post_Approval_Changes_in_Medical_Devices_%E2%80%93_What_Is_the_Approval_Process\" >CDSCO Post Approval Changes in Medical Devices \u2013 What Is the Approval Process<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#Approval_Process_for_Major_Changes\" >Approval Process for Major Changes<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#Approval_Process_for_Minor_Changes\" >Approval Process for Minor Changes<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#Tips_to_Stay_Compliant\" >Tips to Stay Compliant<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#Pre-requisites_for_Doing_Post-Approval_Changes_in_Medical_Devices\" >Pre-requisites for Doing Post-Approval Changes in Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/post-approval-changes-for-medical-devices-in-india\/#How_Can_Dueran_Consultant_Help\" >How Can Dueran Consultant Help?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_Are_Post-Approval_Changes_for_Medical_Devices_in_India\"><\/span>What Are <span style=\"color: #2490eb;\">Post-Approval Changes<\/span> for Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Post-approval changes for medical devices in India refer to any modifications in the following aspects:<\/p>\n<ol style=\"text-align: justify;\">\n<li>Device Design<\/li>\n<li>Material of Construction<\/li>\n<li>Intended Use<\/li>\n<li>Manufacturing Process<\/li>\n<li>Testing<\/li>\n<li>Labelling<\/li>\n<li>Packaging<\/li>\n<\/ol>\n<p style=\"text-align: justify;\">Such changes are divided into major and minor changes. Major changes are those that require prior approval, and minor changes are those that require only notification. These post-approval changes determine the action that the manufacturer or importer must take before implementing the changes.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Types_of_Post-Approval_Changes_for_Medical_Devices\"><\/span><span style=\"color: #2490eb;\">Types of Post-Approval Changes<\/span> for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">According to the Sixth Schedule of the Medical Device Rules, 2017, post-approval changes in medical devices fall into two categories:<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"1_Major_Changes_Require_CDSCO_Prior_Approval\"><\/span><strong>1. <span style=\"color: #2490eb;\">Major<\/span> Changes (Require CDSCO Prior Approval)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Major changes are significant as they impact the quality, safety, or performance of your device. You need approval from CDSCO before implementing the changes. List of major post-approval Changes are as follows:<\/p>\n<p style=\"text-align: justify;\"><strong>1.<\/strong> Material of construction<\/p>\n<p style=\"text-align: justify;\"><strong>2.<\/strong> Design which shall affect quality in respect of its specifications, indication for use; performance and stability of the medical device<\/p>\n<p style=\"text-align: justify;\"><strong>3.<\/strong> Intended use or indication for use<\/p>\n<p style=\"text-align: justify;\"><strong>4.<\/strong> Method of sterilization<\/p>\n<p style=\"text-align: justify;\"><strong>5.<\/strong> Approved Shelf life<\/p>\n<p style=\"text-align: justify;\"><strong>6.<\/strong> Name or address of:<\/p>\n<p style=\"text-align: justify;\">(i) Domestic manufacturer or its manufacturing site<\/p>\n<p style=\"text-align: justify;\">(ii) Overseas manufacturer or its manufacturing site (for import only)<\/p>\n<p style=\"text-align: justify;\">(iii) Authorised agent (for import only)<\/p>\n<p style=\"text-align: justify;\"><strong>7.<\/strong> label excluding change in font size, font type, color, label design<\/p>\n<p style=\"text-align: justify;\"><strong>8.<\/strong> Manufacturing process, equipment or testing which shall affect quality of the device<\/p>\n<p style=\"text-align: justify;\"><strong>9.<\/strong> Primary packaging material<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"2_Minor_Changes_Require_CDSCO_Notification_Only\"><\/span><strong>2. <span style=\"color: #2490eb;\">Minor<\/span> Changes (Require CDSCO Notification Only)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Minor changes impact the quality, safety, or performance of the device in a way that isn&#8217;t significant. So, they need just the CDSCO notification. But it is important to notify the CDSCO within the stipulated timelines of the change. Examples of minor changes include:<\/p>\n<ol style=\"text-align: justify;\">\n<li>Design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device;<\/li>\n<li>Minor Changes in the manufacturing process, equipment, or testing which shall not affect quality of the device;<\/li>\n<li>Packaging specifications excluding primary packaging material<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CDSCO_Post_Approval_Changes_in_Medical_Devices_%E2%80%93_What_Is_the_Approval_Process\"><\/span>CDSCO Post Approval Changes in Medical Devices \u2013 <span style=\"color: #2490eb;\">What Is the Approval Process<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><em>The approval process depends on the type of the change, if it is major or minor:<\/em><\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Approval_Process_for_Major_Changes\"><\/span>Approval Process for <span style=\"color: #2490eb;\">Major Changes<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul style=\"text-align: justify;\">\n<li>Application Submission: Manufacturers\/ Importers must submit a request to the CDSCO for approval.<\/li>\n<li>CDSCO Review: The CDSCO reviews the request and either grants approval or raises objections.<\/li>\n<li>Approval: After successful examination of documents, authority grant the approval for major changes.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Approval_Process_for_Minor_Changes\"><\/span>Approval Process for <span style=\"color: #2490eb;\">Minor Changes<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul style=\"text-align: justify;\">\n<li>Notification: Inform the CDSCO within 30 days of making the change.<\/li>\n<li>Approval: Only notification is required.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Tips_to_Stay_Compliant\"><\/span><span style=\"color: #2490eb;\">Tips<\/span> to Stay Compliant<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\"><em>Here are some effective ways to stay compliant with the medical devices post-approval changes process:<\/em><\/p>\n<ul style=\"text-align: justify;\">\n<li>Categorise changes into major\/ and minor categories accurately.<\/li>\n<li>Have clear documentation for all the major and minor changes.<\/li>\n<li>Comply the official timelines for notifications related to your change and follow them diligently.<\/li>\n<li>Communicate with our regulatory experts for guidance that will help you avoid compliance issues.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Pre-requisites_for_Doing_Post-Approval_Changes_in_Medical_Devices\"><\/span>Pre-requisites for Doing Post-Approval Changes in <span style=\"color: #2490eb;\">Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Before you make the changes and ask for approval, you must have the following ready:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Manufacturers\/ Importers must have valid manufacturing\/ Import license. It means Form MD-5\/Form MD-6 for Class A\/B or Form MD-9\/ Form MD-10 for Class C\/D devices. Importers must hold a valid import license in Form MD-15.<\/li>\n<li>Manufacturers\/ Importers must have updated Device Master File (DMF) or Plant Master file (PMF) as applicable. It should be in line with the proposed change.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_Can_Dueran_Consultant_Help\"><\/span>How Can <span style=\"color: #2490eb;\">Dueran Consultant<\/span> Help?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">As a leader in offering regulatory guidance and support, we help you to understand whether it is major or minor changes, further preparation of technical documentation and managing submissions through the CDSCO MD SUGAM portal.<\/p>\n<p style=\"text-align: justify;\">We also keep a steady communication with the CDSCO officials on your behalf, track timelines for approvals or notifications, and provide customised compliance advice. You can seek our assistance in filing of major or minor Post approval changes to the existing manufacturing or Import licenses by contacting us anytime or schedule a free consultation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, medical devices are strictly regulated under the Medical Device Rules, 2017, by the Central Drugs Standard Control Organization<\/p>\n","protected":false},"author":1,"featured_media":8433,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[624,622,623,620,621],"class_list":["post-8386","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-post-approval-changes-in-medical-devices","tag-medical-devices-post-approval-changes","tag-post-approval-changes-for-medical-devices-in-india","tag-post-approval-changes-in-medical-devices","tag-post-approval-medical-devices-changes"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Post-Approval Changes for Medical Devices in India | CDSCO<\/title>\n<meta name=\"description\" content=\"Navigate post-approval Changes for medical devices under CDSCO. 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