{"id":1015,"date":"2026-10-09T05:55:40","date_gmt":"2026-10-09T05:55:40","guid":{"rendered":"https:\/\/satoriocs.com\/blogs\/?p=1015"},"modified":"2026-10-09T06:11:55","modified_gmt":"2026-10-09T06:11:55","slug":"class-c-d-manufacturing-licence-in-india-complete-guide-2026","status":"publish","type":"post","link":"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/","title":{"rendered":"Class C &#038; D Manufacturing Licence under MDR 2017 \u2013 Complete Step-by-Step Guide"},"content":{"rendered":"<p><!--\n  RANK MATH SETTINGS (enter these in the plugin, not in the post body)\n  Focus Keyword : Class C and D manufacturing licence\n  SEO Title     : Class C & D Manufacturing Licence in India: Complete Guide (2026)\n  Meta Desc     : Complete step-by-step guide to get Class C & D manufacturing licence under MDR 2017. Documents, process, timelines, fees and expert support from Satori OCS.\n  URL slug      : class-c-d-manufacturing-licence-mdr-2017\n--><\/p>\n<p><!-- ==================== CLASS C & D MANUFACTURING LICENCE BLOG ==================== --><\/p>\n<section class=\"pt-50 pb-50\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-12\">\n<p>                <!-- Introduction --><\/p>\n<p style=\"font-size:16px; line-height:1.7; text-align:justify;\">\n                    A <strong>Class C &#038; D manufacturing licence<\/strong> is mandatory if you plan to manufacture moderate-high or high-risk medical devices in India under the <strong>Medical Devices Rules, 2017 (MDR 2017)<\/strong>. These devices are regulated by the <strong>Central Licensing Authority (CLA)<\/strong> under CDSCO.\n                <\/p>\n<p style=\"font-size:16px; line-height:1.7; text-align:justify;\">\n                    This detailed guide covers the entire process \u2014 from classification to licence grant \u2014 so you can apply correctly and avoid common rejections.\n                <\/p>\n<p>                <!-- What devices need the licence --><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_89 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:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#What_Devices_Need_a_Class_C_D_Manufacturing_Licence\" >What Devices Need a Class C &#038; D Manufacturing Licence?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Who_Grants_the_Class_C_D_Manufacturing_Licence\" >Who Grants the Class C &#038; D Manufacturing Licence?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step-by-Step_Process_to_Get_Class_C_D_Manufacturing_Licence\" >Step-by-Step Process to Get Class C &#038; D Manufacturing Licence<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Class_C_D_Manufacturing_Licence_Process_Flowchart\" >Class C &#038; D Manufacturing Licence Process Flowchart<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_1_Confirm_Device_Classification\" >Step 1: Confirm Device Classification<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_2_Ensure_Quality_Management_System_QMS_Compliance\" >Step 2: Ensure Quality Management System (QMS) Compliance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_3_Appoint_Competent_Technical_Staff\" >Step 3: Appoint Competent Technical Staff<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_4_Prepare_Required_Documents\" >Step 4: Prepare Required Documents<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_5_Submit_Online_Application\" >Step 5: Submit Online Application<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_6_Site_Inspection_Audit\" >Step 6: Site Inspection \/ Audit<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Step_7_Scrutiny_Grant_of_Licence\" >Step 7: Scrutiny &#038; Grant of Licence<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Important_Timelines_for_Class_C_D_Manufacturing_Licence\" >Important Timelines for Class C &#038; D Manufacturing Licence<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Class_C_D_Manufacturing_Licence_Validity_Retention_Fee\" >Class C &#038; D Manufacturing Licence Validity &#038; Retention Fee<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Common_Reasons_for_Class_C_D_Manufacturing_Licence_Rejection\" >Common Reasons for Class C &#038; D Manufacturing Licence Rejection<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Class_C_D_Manufacturing_Licence_FAQs\" >Class C &#038; D Manufacturing Licence FAQs<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Who_issues_the_Class_C_D_manufacturing_licence\" >Who issues the Class C &#038; D manufacturing licence?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Is_Notified_Body_audit_mandatory_for_Class_C_D\" >Is Notified Body audit mandatory for Class C &#038; D?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Can_I_apply_for_both_Class_C_and_Class_D_devices_in_one_application\" >Can I apply for both Class C and Class D devices in one application?<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#How_Satori_OCS_Can_Help_You\" >How Satori OCS Can Help You<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/satoriocs.com\/blogs\/class-c-d-manufacturing-licence-in-india-complete-guide-2026\/#Need_Expert_Assistance_for_Your_Class_C_D_Manufacturing_Licence\" >Need Expert Assistance for Your Class C &#038; D Manufacturing Licence?<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"What_Devices_Need_a_Class_C_D_Manufacturing_Licence\"><\/span>\n                    What Devices Need a Class C &#038; D Manufacturing Licence?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Class C devices are moderate-high risk and Class D devices are high risk. Common examples include:\n                <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Ventilators and anaesthesia machines<\/li>\n<li>Infusion pumps and dialysis equipment<\/li>\n<li>Orthopaedic implants and bone fixation devices<\/li>\n<li>Cardiac stents, pacemakers and heart valves<\/li>\n<li>Intraocular lenses and cochlear implants<\/li>\n<li>High-risk catheters and implantable devices<\/li>\n<li>Advanced diagnostic imaging systems<\/li>\n<\/ul>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    The exact classification is decided based on the parameters given in the <strong>First Schedule<\/strong> of MDR 2017 and the latest <a href=\"https:\/\/cdsco.gov.in\/\" target=\"_blank\" rel=\"noopener\">CDSCO<\/a> Class-wise list.\n                <\/p>\n<p>                <!-- Who Grants the Licence --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Who_Grants_the_Class_C_D_Manufacturing_Licence\"><\/span>\n                    Who Grants the Class C &#038; D Manufacturing Licence?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li><strong>Authority:<\/strong> Central Licensing Authority (Drugs Controller General of India \/ CDSCO)<\/li>\n<li><strong>Application Form:<\/strong> Form MD-7 (regular licence) or Form MD-8 (Loan Licence)<\/li>\n<li><strong>Licence Issued in:<\/strong> Form MD-9 (regular) or Form MD-10 (Loan Licence)<\/li>\n<\/ul>\n<p>                <!-- Step-by-Step Process --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Step-by-Step_Process_to_Get_Class_C_D_Manufacturing_Licence\"><\/span>\n                    Step-by-Step Process to Get Class C &#038; D Manufacturing Licence<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>                <!-- Class C & D Manufacturing Licence Process Flowchart --><\/p>\n<div style=\"margin:40px 0; padding:30px 20px; background:#f7f9fc; border-radius:10px;\">\n<h2 style=\"text-align:center; color:#102A43; margin-bottom:30px;\"><span class=\"ez-toc-section\" id=\"Class_C_D_Manufacturing_Licence_Process_Flowchart\"><\/span>\n                        Class C &#038; D Manufacturing Licence Process Flowchart<br \/>\n                    <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div style=\"display:flex; flex-direction:column; align-items:center; gap:0;\">\n                        <!-- Step 1 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 1<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Confirm Device Classification\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Check CDSCO Class-wise List &#038; First Schedule\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 2 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 2<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Ensure QMS Compliance\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                MDR 2017 Fifth Schedule \/ ISO 13485:2016\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 3 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 3<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Appoint Competent Technical Staff\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Manufacturing &#038; Testing In-charge\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 4 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 4<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Prepare Required Documents\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                MD-7\/MD-8, PMF, DMF, QMS Documents &#038; Supporting Records\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 5 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 5<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Submit Online Application\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Submit Application with Prescribed Fee to CLA\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 6 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#ffffff; border:2px solid #F57C00; border-radius:10px; padding:18px; text-align:center; box-shadow:0 3px 10px rgba(0,0,0,0.06);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 6<\/strong><\/p>\n<div style=\"color:#102A43; font-size:17px; font-weight:600; margin-top:5px;\">\n                                Site Inspection \/ Audit\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Inspection by Medical Device Officers \/ CDSCO\n                            <\/div>\n<\/p><\/div>\n<div style=\"font-size:28px; color:#F57C00; line-height:35px;\">\u2193<\/div>\n<p>                        <!-- Step 7 --><\/p>\n<div style=\"width:90%; max-width:650px; background:#102A43; border:2px solid #102A43; border-radius:10px; padding:20px; text-align:center; box-shadow:0 4px 12px rgba(0,0,0,0.10);\">\n                            <strong style=\"color:#F57C00; font-size:18px;\">Step 7<\/strong><\/p>\n<div style=\"color:#ffffff; font-size:18px; font-weight:600; margin-top:5px;\">\n                                Scrutiny &#038; Grant of Licence\n                            <\/div>\n<div style=\"font-size:14px; color:#ffffff; margin-top:5px;\">\n                                Central Licensing Authority \u2192 Form MD-9\n                            <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_1_Confirm_Device_Classification\"><\/span>\n                    Step 1: Confirm Device Classification<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Verify that your device is Class C or Class D using the CDSCO Class-wise list and First Schedule parameters. Wrong classification is one of the most common reasons for rejection.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_2_Ensure_Quality_Management_System_QMS_Compliance\"><\/span>\n                    Step 2: Ensure Quality Management System (QMS) Compliance<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Your manufacturing site must comply with the <strong>Quality Management System<\/strong> requirements specified in the <strong>Fifth Schedule<\/strong> of MDR 2017. Most manufacturers implement <strong>ISO 13485:2016<\/strong> as it aligns closely with these requirements. For Class C and D devices, the QMS requirements are more stringent.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_3_Appoint_Competent_Technical_Staff\"><\/span>\n                    Step 3: Appoint Competent Technical Staff<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    You must appoint:\n                <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li><strong>Manufacturing in-charge:<\/strong> Degree in relevant Engineering \/ Pharmacy \/ Science + 2 years experience <strong>or<\/strong> Diploma + 4 years experience<\/li>\n<li><strong>Testing in-charge:<\/strong> Degree \/ Diploma in relevant field + minimum 2 years testing experience<\/li>\n<\/ul>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_4_Prepare_Required_Documents\"><\/span>\n                    Step 4: Prepare Required Documents<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Key documents for your Class C &#038; D manufacturing licence application include:\n                <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Covering letter<\/li>\n<li>Duly filled Form MD-7 \/ MD-8<\/li>\n<li>Constitution documents of the firm<\/li>\n<li>Site \/ Plant Master File (Appendix I of Fourth Schedule)<\/li>\n<li>Device Master File (Appendix II or III of Fourth Schedule)<\/li>\n<li>Essential Principles Checklist<\/li>\n<li>Undertaking for QMS compliance (Fifth Schedule)<\/li>\n<li>Layout of manufacturing premises<\/li>\n<li>List of equipment and instruments<\/li>\n<li>Details of technical staff with qualification and experience<\/li>\n<li>ISO 13485 certificate (highly recommended)<\/li>\n<li>Stability data \/ performance evaluation reports (as applicable)<\/li>\n<li>Fee challan<\/li>\n<\/ul>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_5_Submit_Online_Application\"><\/span>\n                    Step 5: Submit Online Application<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Submit the application through the CDSCO online portal along with the prescribed fee to the Central Licensing Authority.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_6_Site_Inspection_Audit\"><\/span>\n                    Step 6: Site Inspection \/ Audit<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    For Class C and D devices, the manufacturing site is inspected by Medical Device Officers or officers designated by the Central Licensing Authority to verify QMS compliance and manufacturing capability.\n                <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Inspection is more detailed compared to Class A and B devices<\/li>\n<li>Focus is on design controls, risk management, process validation and post-market systems<\/li>\n<\/ul>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_7_Scrutiny_Grant_of_Licence\"><\/span>\n                    Step 7: Scrutiny &#038; Grant of Licence<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    The Central Licensing Authority scrutinises the documents and inspection report. If everything is satisfactory, the Class C or D manufacturing licence is granted in <strong>Form MD-9<\/strong> (or MD-10 for loan licence).\n                <\/p>\n<p>                <!-- Important Timelines --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Important_Timelines_for_Class_C_D_Manufacturing_Licence\"><\/span>\n                    Important Timelines for Class C &#038; D Manufacturing Licence<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" style=\"font-size:15px;\">\n<thead style=\"background-color:#6ebb21; color:white;\">\n<tr>\n<th>Activity<\/th>\n<th>Timeline<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Document scrutiny<\/td>\n<td>As per Central Licensing Authority<\/td>\n<\/tr>\n<tr>\n<td>Site inspection \/ audit<\/td>\n<td>As scheduled by CDSCO<\/td>\n<\/tr>\n<tr>\n<td>Inspection report submission<\/td>\n<td>Within prescribed timeline after inspection<\/td>\n<\/tr>\n<tr>\n<td>Licence grant after satisfactory report<\/td>\n<td>As per CLA decision<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>                <!-- Licence Validity --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Class_C_D_Manufacturing_Licence_Validity_Retention_Fee\"><\/span>\n                    Class C &#038; D Manufacturing Licence Validity &#038; Retention Fee<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    The licence remains valid in perpetuity, subject to payment of <strong>licence retention fee<\/strong> every 5 years as specified in the Second Schedule of <a href=\"https:\/\/cdsco.gov.in\/\" target=\"_blank\" rel=\"noopener\">MDR 2017<\/a>.\n                <\/p>\n<p>                <!-- Common Reasons for Rejection --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Common_Reasons_for_Class_C_D_Manufacturing_Licence_Rejection\"><\/span>\n                    Common Reasons for Class C &#038; D Manufacturing Licence Rejection<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Incomplete or incorrect Device Master File \/ Plant Master File<\/li>\n<li>Non-compliance with Fifth Schedule (QMS)<\/li>\n<li>Lack of qualified technical staff<\/li>\n<li>Improper classification of device<\/li>\n<li>Incomplete Essential Principles Checklist<\/li>\n<li>Insufficient design control or risk management documentation<\/li>\n<li>Gaps in process validation or stability data<\/li>\n<\/ul>\n<p>                <!-- FAQ --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Class_C_D_Manufacturing_Licence_FAQs\"><\/span>\n                    Class C &#038; D Manufacturing Licence FAQs<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Who_issues_the_Class_C_D_manufacturing_licence\"><\/span>\n                    Who issues the Class C &#038; D manufacturing licence?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    The Central Licensing Authority (CDSCO) issues it in Form MD-9, or MD-10 for a loan licence.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Is_Notified_Body_audit_mandatory_for_Class_C_D\"><\/span>\n                    Is Notified Body audit mandatory for Class C &#038; D?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    For Class C and D devices, the inspection is primarily conducted by officers of the Central Licensing Authority. The process is more rigorous than Class B.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Can_I_apply_for_both_Class_C_and_Class_D_devices_in_one_application\"><\/span>\n                    Can I apply for both Class C and Class D devices in one application?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Yes, provided the devices can be grouped as per the medical device grouping guidelines and are manufactured at the same site under the same Quality Management System.\n                <\/p>\n<p>                <!-- How Satori OCS Can Help --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"How_Satori_OCS_Can_Help_You\"><\/span>\n                    How Satori OCS Can Help You<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Navigating the Class C &#038; D manufacturing licence process requires accurate documentation, robust QMS implementation, and proper coordination with the Central Licensing Authority.\n                <\/p>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    At <strong><a href=\"https:\/\/satoriocs.com\/\" style=\"color:#6ebb21;\">Satori One Click Solutions (Satori OCS)<\/a><\/strong>, we provide end-to-end support for medical device manufacturers, including:\n                <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Device classification support<\/li>\n<li>Preparation of Plant Master File &#038; Device Master File<\/li>\n<li>QMS (ISO 13485) gap assessment and implementation<\/li>\n<li>Complete documentation for Form MD-7 \/ MD-9<\/li>\n<li>Risk management and design control documentation support<\/li>\n<li>Liaison with Central Licensing Authority \/ CDSCO<\/li>\n<\/ul>\n<p style=\"font-size:16px; line-height:1.7; margin-top:20px;\">\n                    We have successfully helped multiple clients obtain manufacturing and import licences under MDR 2017.\n                <\/p>\n<p>                <!-- CTA Box --><\/p>\n<div style=\"background-color:#f8f9fa; border-left:5px solid #6ebb21; padding:25px 30px; margin-top:40px; border-radius:6px;\">\n<h4 style=\"color:#6ebb21; margin-bottom:15px;\"><span class=\"ez-toc-section\" id=\"Need_Expert_Assistance_for_Your_Class_C_D_Manufacturing_Licence\"><\/span>Need Expert Assistance for Your Class C &#038; D Manufacturing Licence?<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; margin-bottom:15px;\">\n                        Visit our Medical Devices Licensing page or schedule a free consultation with our experts.\n                    <\/p>\n<p style=\"margin-bottom:8px;\">\n                        <a href=\"https:\/\/satoriocs.com\/Medical-Devices-Licensing-in-India\" style=\"color:#6ebb21; font-weight:600; text-decoration:underline;\"><br \/>\n                            Medical Devices Licensing in India<br \/>\n                        <\/a>\n                    <\/p>\n<p style=\"margin-bottom:8px;\">\n                        <a href=\"https:\/\/satoriocs.com\/\" style=\"color:#6ebb21; font-weight:600; text-decoration:underline;\"><br \/>\n                            Schedule Free Consultation<br \/>\n                        <\/a>\n                    <\/p>\n<p style=\"margin-top:15px; margin-bottom:0; font-size:15px;\">\n                        <strong>Email:<\/strong> satoriocs@gmail.com<br \/>\n                        <strong>Phone:<\/strong> +91 98290 98077\n                    <\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<p><!-- ==================== END OF BLOG ==================== --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Class C &#038; D manufacturing licence is mandatory if you plan to manufacture moderate-high or high-risk medical devices in India under the Medical Devices Rules, 2017 (MDR 2017). These devices are regulated by the Central Licensing Authority (CLA) under CDSCO. This detailed guide covers the entire process \u2014 from classification to licence grant \u2014 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1021,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pagelayer_contact_templates":[],"_pagelayer_content":"","footnotes":""},"categories":[1,4],"tags":[48,139,34,68],"class_list":["post-1015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home","category-medical-device-regulations-global-compliance","tag-health-canada","tag-iso-13485","tag-medical-device","tag-regulatory-requirements"],"_links":{"self":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/comments?post=1015"}],"version-history":[{"count":1,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1015\/revisions"}],"predecessor-version":[{"id":1019,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1015\/revisions\/1019"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media\/1021"}],"wp:attachment":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media?parent=1015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/categories?post=1015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/tags?post=1015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}