{"id":999,"date":"2026-10-06T07:10:55","date_gmt":"2026-10-06T07:10:55","guid":{"rendered":"https:\/\/satoriocs.com\/blogs\/?p=999"},"modified":"2026-10-09T06:23:46","modified_gmt":"2026-10-09T06:23:46","slug":"how-to-get-class-b-medical-device-licence-in-india-mdr-2017","status":"publish","type":"post","link":"https:\/\/satoriocs.com\/blogs\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/","title":{"rendered":"Complete Step-by-Step Guide for Class B Manufacturing Licence under MDR 2017"},"content":{"rendered":"<p><!--\nRANK MATH SETTINGS (enter these in the plugin, not in the post body)\nFocus Keyword : Class B manufacturing licence\nSEO Title     : Class B Manufacturing Licence in India: Easy 7-Step Guide (2026)\nMeta Desc     : Get your Class B manufacturing licence under MDR 2017 without rejections. Learn the 7 steps, documents, timelines and fees in this complete guide for India.\nURL slug      : class-b-manufacturing-licence\n--><\/p>\n<p><!-- ==================== CLASS B 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 B manufacturing licence<\/strong> is mandatory if you plan to manufacture low-moderate risk medical devices in India under the <strong>Medical Devices Rules, 2017 (MDR 2017)<\/strong>. Class B devices are regulated by the <strong>State Licensing Authority (SLA)<\/strong>.\n            <\/p>\n<p style=\"font-size:16px; line-height:1.7; text-align:justify;\">\n                This detailed guide covers the entire process, from classification to licence grant, so you can apply correctly and avoid common rejections.<br \/>\n                 <!-- 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#What_Devices_Need_a_Class_B_Manufacturing_Licence\" >What Devices Need a Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Who_Grants_the_Class_B_Manufacturing_Licence\" >Who Grants the Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Step-by-Step_Process_to_Get_Class_B_Manufacturing_Licence\" >Step-by-Step Process to Get Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Class_B_Manufacturing_Licence_Process_Flowchart\" >Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Step_6_Notified_Body_Audit\" >Step 6: Notified Body 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Step_7_Scrutiny_Grant_of_Licence\" >Step 7: Scrutiny &amp; 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Important_Timelines_for_a_Class_B_Manufacturing_Licence\" >Important Timelines for a Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Class_B_Manufacturing_Licence_Validity_Retention_Fee\" >Class B Manufacturing Licence Validity &amp; 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Common_Reasons_for_Class_B_Manufacturing_Licence_Rejection\" >Common Reasons for Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Class_B_Manufacturing_Licence_FAQs\" >Class B 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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#How_long_does_a_Class_B_manufacturing_licence_take\" >How long does a Class B manufacturing licence take?<\/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\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Who_issues_the_Class_B_manufacturing_licence\" >Who issues the Class B manufacturing 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-18\" href=\"https:\/\/satoriocs.com\/blogs\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#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-19\" href=\"https:\/\/satoriocs.com\/blogs\/how-to-get-class-b-medical-device-licence-in-india-mdr-2017\/#Need_Expert_Assistance_for_Your_Class_B_Manufacturing_Licence\" >Need Expert Assistance for Your Class B 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_B_Manufacturing_Licence\"><\/span>\n                What Devices Need a Class B Manufacturing Licence?<br \/>\n            <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"font-size:16px; line-height:1.7;\">\n                Class B medical devices are low-to-moderate risk devices. Common examples include:\n            <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Hypodermic needles and syringes<\/li>\n<li>Blood pressure monitors<\/li>\n<li>Surgical gloves (sterile)<\/li>\n<li>Urinary catheters<\/li>\n<li>Suction equipment<\/li>\n<li>Hearing aids<\/li>\n<li>Ultrasound transducers<\/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_B_Manufacturing_Licence\"><\/span>\n                Who Grants the Class B 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> State Licensing Authority (State Drugs Controller)<\/li>\n<li><strong>Application Form:<\/strong> Form MD-3 (regular licence) or Form MD-4 (Loan Licence)<\/li>\n<li><strong>Licence Issued in:<\/strong> Form MD-5 (regular) or Form MD-6 (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_B_Manufacturing_Licence\"><\/span>\n                Step-by-Step Process to Get Class B Manufacturing Licence<br \/>\n            <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><!-- Class B 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_B_Manufacturing_Licence_Process_Flowchart\"><\/span>\n        Class B 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<p>        <!-- 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-3\/MD-4, 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\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                Notified Body Audit\n            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                Manufacturing Site &#038; QMS Compliance Audit\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                State Licensing Authority \u2192 Form MD-5\n            <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/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 B 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.\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 B 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-3 \/ MD-4<\/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<\/li>\n<li>ISO 13485 certificate (highly recommended)<\/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 designated online portal of the Ministry of Health &amp; Family Welfare \/ CDSCO along with the prescribed fee.\n            <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_6_Notified_Body_Audit\"><\/span>\n                Step 6: Notified Body Audit<br \/>\n            <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                For Class B devices, a registered <strong>Notified Body<\/strong> must audit your manufacturing site for QMS compliance.\n            <\/p>\n<ul style=\"font-size:16px; line-height:1.8; padding-left:20px;\">\n<li>Audit should be completed within 90 days of application<\/li>\n<li>Notified Body submits the audit report to the State Licensing Authority within 30 days of audit completion<\/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 &amp; 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 State Licensing Authority scrutinises the documents and audit report. If everything is satisfactory, the Class B manufacturing licence is granted in <strong>Form MD-5<\/strong> (or MD-6 for loan licence) within 20 days of receiving the audit report.\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_a_Class_B_Manufacturing_Licence\"><\/span>\n                Important Timelines for a Class B 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 State Licensing Authority<\/td>\n<\/tr>\n<tr>\n<td>Notified Body audit<\/td>\n<td>Within 90 days of application<\/td>\n<\/tr>\n<tr>\n<td>Audit report submission<\/td>\n<td>Within 30 days of audit<\/td>\n<\/tr>\n<tr>\n<td>Licence grant after audit report<\/td>\n<td>Within 20 days<\/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_B_Manufacturing_Licence_Validity_Retention_Fee\"><\/span>\n                Class B Manufacturing Licence Validity &amp; 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_B_Manufacturing_Licence_Rejection\"><\/span>\n                Common Reasons for Class B 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<\/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_B_Manufacturing_Licence_FAQs\"><\/span>\n                Class B 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=\"How_long_does_a_Class_B_manufacturing_licence_take\"><\/span>\n                How long does a Class B manufacturing licence take?<br \/>\n            <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                The Notified Body audit is due within 90 days of application, and the licence is granted within 20 days of the audit report reaching the State Licensing Authority. Document scrutiny time varies by state.\n            <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Who_issues_the_Class_B_manufacturing_licence\"><\/span>\n                Who issues the Class B manufacturing licence?<br \/>\n            <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                The State Licensing Authority (State Drugs Controller) issues it in Form MD-5, or MD-6 for a loan licence.\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 B manufacturing licence process requires accurate documentation, proper QMS implementation, and coordination with Notified Bodies and the State 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 &amp; Device Master File<\/li>\n<li>QMS (ISO 13485) gap assessment and implementation<\/li>\n<li>Complete documentation for Form MD-3 \/ MD-5<\/li>\n<li>Coordination with Notified Bodies<\/li>\n<li>Liaison with State Licensing Authorities<\/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_B_Manufacturing_Licence\"><\/span>Need Expert Assistance for Your Class B 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<\/div>\n<\/section>\n<p> <!-- ==================== END OF BLOG ==================== --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Class B manufacturing licence is mandatory if you plan to manufacture low-moderate risk medical devices in India under the Medical Devices Rules, 2017 (MDR 2017). Class B devices are regulated by the State Licensing Authority (SLA). This detailed guide covers the entire process, from classification to licence grant, so you can apply correctly and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1023,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pagelayer_contact_templates":[],"_pagelayer_content":"","footnotes":""},"categories":[1,4],"tags":[34,73,68],"class_list":["post-999","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home","category-medical-device-regulations-global-compliance","tag-medical-device","tag-regulatory-compliance","tag-regulatory-requirements"],"_links":{"self":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/999","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=999"}],"version-history":[{"count":7,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/999\/revisions"}],"predecessor-version":[{"id":1013,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/999\/revisions\/1013"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media\/1023"}],"wp:attachment":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media?parent=999"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/categories?post=999"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/tags?post=999"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}