{"id":1024,"date":"2026-10-09T11:50:08","date_gmt":"2026-10-09T11:50:08","guid":{"rendered":"https:\/\/satoriocs.com\/blogs\/?p=1024"},"modified":"2026-10-09T11:50:11","modified_gmt":"2026-10-09T11:50:11","slug":"1024-2","status":"publish","type":"post","link":"https:\/\/satoriocs.com\/blogs\/1024-2\/","title":{"rendered":"Import Licence of Medical Devices in India: Complete Guide (2026)"},"content":{"rendered":"<p><!--\n  RANK MATH SETTINGS (enter these in the plugin, not in the post body)\n  Focus Keyword : Import Licence of Medical Devices in India\n  SEO Title     : Import Licence of Medical Devices in India: Complete Guide (2026)\n  Meta Desc     : Complete step-by-step guide to get Import Licence for Medical Devices under MDR 2017. Form MD-14, documents, process, timelines and expert support from Satori OCS.\n  URL slug      : import-licence-medical-devices-india\n--><\/p>\n<p><!-- ==================== IMPORT LICENCE OF MEDICAL DEVICES 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                    An <strong>Import Licence<\/strong> is mandatory if you want to import medical devices into India under the <strong>Medical Devices Rules, 2017 (MDR 2017)<\/strong>. The licence is granted by the <strong>Central Licensing Authority (CLA)<\/strong> under CDSCO in <strong>Form MD-15<\/strong>.\n                <\/p>\n<p style=\"font-size:16px; line-height:1.7; text-align:justify;\">\n                    This detailed guide covers the complete process \u2014 from classification to licence grant \u2014 so you can apply correctly and avoid common rejections.\n                <\/p>\n<p>                <!-- What is Import 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\/1024-2\/#What_is_an_Import_Licence_for_Medical_Devices\" >What is an Import Licence for Medical Devices?<\/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\/1024-2\/#Who_Needs_an_Import_Licence\" >Who Needs an Import 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\/1024-2\/#Who_Grants_the_Import_Licence\" >Who Grants the Import 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\/1024-2\/#Step-by-Step_Process_to_Get_Import_Licence_of_Medical_Devices\" >Step-by-Step Process to Get Import Licence of Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#Import_Licence_Process_Flowchart\" >Import 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-6\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#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-7\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#Step_2_Appoint_Authorised_Agent_in_India\" >Step 2: Appoint Authorised Agent in India<\/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\/1024-2\/#Step_3_Prepare_Required_Documents\" >Step 3: 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\/1024-2\/#Step_4_Submit_Online_Application_Form_MD-14\" >Step 4: Submit Online Application (Form MD-14)<\/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\/1024-2\/#Step_5_Scrutiny_by_CDSCO\" >Step 5: Scrutiny by CDSCO<\/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\/1024-2\/#Step_6_Overseas_Inspection_if_required\" >Step 6: Overseas Inspection (if required)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#Step_7_Grant_of_Import_Licence\" >Step 7: Grant of Import 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-13\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#Important_Points_About_Import_Licence\" >Important Points About Import Licence<\/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\/1024-2\/#Common_Reasons_for_Import_Licence_Rejection\" >Common Reasons for Import 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\/1024-2\/#Import_Licence_FAQs\" >Import 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\/1024-2\/#Is_Import_Licence_required_for_all_classes_of_medical_devices\" >Is Import Licence required for all classes of medical devices?<\/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\/1024-2\/#Can_a_foreign_manufacturer_apply_directly\" >Can a foreign manufacturer apply directly?<\/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\/1024-2\/#How_long_does_it_take_to_get_an_Import_Licence\" >How long does it take to get an Import 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-19\" href=\"https:\/\/satoriocs.com\/blogs\/1024-2\/#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\/1024-2\/#Need_Expert_Assistance_for_Your_Import_Licence\" >Need Expert Assistance for Your Import 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_is_an_Import_Licence_for_Medical_Devices\"><\/span>\n                    What is an Import Licence for Medical Devices?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    An Import Licence allows a company to legally import medical devices (Class A, B, C or D) into India for sale or distribution. Foreign manufacturers must appoint an <strong>Authorised Agent<\/strong> in India who applies for the licence on their behalf.\n                <\/p>\n<p>                <!-- Who Needs Import Licence --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Who_Needs_an_Import_Licence\"><\/span>\n                    Who Needs an Import 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>Foreign manufacturers of medical devices<\/li>\n<li>Indian importers \/ authorised agents<\/li>\n<li>Companies importing Class A, B, C or D medical devices<\/li>\n<li>Companies importing In-vitro Diagnostic (IVD) devices<\/li>\n<\/ul>\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_Import_Licence\"><\/span>\n                    Who Grants the Import 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 (CDSCO)<\/li>\n<li><strong>Application Form:<\/strong> Form MD-14<\/li>\n<li><strong>Licence Issued in:<\/strong> Form MD-15<\/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_Import_Licence_of_Medical_Devices\"><\/span>\n                    Step-by-Step Process to Get Import Licence of Medical Devices<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>                <!-- Import 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=\"Import_Licence_Process_Flowchart\"><\/span>\n                        Import 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                                Appoint Authorised Agent in India\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Power of Attorney is Mandatory\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                                Prepare Required Documents\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Free Sale Certificate, ISO 13485, DMF, Labels etc.\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                                Submit Online Application (Form MD-14)\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Apply on CDSCO Portal with Prescribed Fee\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                                Scrutiny by CDSCO\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Document Review &#038; Queries (if any)\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                                Overseas Inspection (if required)\n                            <\/div>\n<div style=\"font-size:14px; color:#243447; margin-top:5px;\">\n                                Especially for Class C &#038; D Devices\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                                Grant of Import Licence\n                            <\/div>\n<div style=\"font-size:14px; color:#ffffff; margin-top:5px;\">\n                                Central Licensing Authority \u2192 Form MD-15\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                    Identify whether your device is Class A, B, C or D using the CDSCO Class-wise list and First Schedule of MDR 2017. Classification decides the documentation and scrutiny level.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_2_Appoint_Authorised_Agent_in_India\"><\/span>\n                    Step 2: Appoint Authorised Agent in India<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Every foreign manufacturer must appoint an <strong>Authorised Agent<\/strong> in India through a valid Power of Attorney. The Authorised Agent is responsible for all regulatory communications with CDSCO.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_3_Prepare_Required_Documents\"><\/span>\n                    Step 3: 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 required for Import 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-14<\/li>\n<li>Power of Attorney in favour of Authorised Agent<\/li>\n<li>Free Sale Certificate from the country of origin (preferably from USA, EU, UK, Canada, Japan or Australia)<\/li>\n<li>ISO 13485 certificate of the manufacturing site<\/li>\n<li>Device Master File \/ Technical documentation<\/li>\n<li>Plant Master File of overseas manufacturing site<\/li>\n<li>Labels and Instructions for Use (IFU)<\/li>\n<li>Essential Principles Checklist<\/li>\n<li>Undertaking regarding residual shelf life<\/li>\n<li>Constitution documents of the Authorised Agent<\/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_4_Submit_Online_Application_Form_MD-14\"><\/span>\n                    Step 4: Submit Online Application (Form MD-14)<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    The Authorised Agent submits the application on the CDSCO online portal 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_5_Scrutiny_by_CDSCO\"><\/span>\n                    Step 5: Scrutiny by CDSCO<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    CDSCO reviews the submitted documents. Queries (if any) are raised and must be replied within the given timeline.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_6_Overseas_Inspection_if_required\"><\/span>\n                    Step 6: Overseas Inspection (if required)<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 Class D devices, CDSCO may conduct an overseas inspection of the manufacturing site. Inspection is usually waived if the device is already approved in regulated markets (USA, EU, UK, Canada, Japan, Australia).\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Step_7_Grant_of_Import_Licence\"><\/span>\n                    Step 7: Grant of Import Licence<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    After satisfactory scrutiny (and inspection if applicable), the Central Licensing Authority grants the Import Licence in <strong>Form MD-15<\/strong>.\n                <\/p>\n<p>                <!-- Important Points --><\/p>\n<h2 style=\"color:#6ebb21; margin-top:40px; margin-bottom:20px; font-size:26px;\"><span class=\"ez-toc-section\" id=\"Important_Points_About_Import_Licence\"><\/span>\n                    Important Points About Import 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>Import Licence is site-specific and product-specific<\/li>\n<li>Residual shelf life of imported devices must meet the requirements (generally minimum 40% or 50% remaining)<\/li>\n<li>Licence remains valid in perpetuity subject to retention fee every 5 years<\/li>\n<li>Any change in constitution, manufacturing site or product requires prior approval or intimation<\/li>\n<\/ul>\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_Import_Licence_Rejection\"><\/span>\n                    Common Reasons for Import 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 documentation<\/li>\n<li>Missing or invalid Free Sale Certificate<\/li>\n<li>Improper Power of Attorney<\/li>\n<li>Non-compliance with residual shelf-life rules<\/li>\n<li>Incorrect device classification<\/li>\n<li>Incomplete Device Master File or labels<\/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=\"Import_Licence_FAQs\"><\/span>\n                    Import 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=\"Is_Import_Licence_required_for_all_classes_of_medical_devices\"><\/span>\n                    Is Import Licence required for all classes of medical devices?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Yes. Import Licence in Form MD-15 is required for Class A, B, C and D medical devices.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"Can_a_foreign_manufacturer_apply_directly\"><\/span>\n                    Can a foreign manufacturer apply directly?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    No. A foreign manufacturer must appoint an Authorised Agent in India who will apply for the Import Licence.\n                <\/p>\n<h4 style=\"margin-top:25px; margin-bottom:10px; font-size:18px; color:#333;\"><span class=\"ez-toc-section\" id=\"How_long_does_it_take_to_get_an_Import_Licence\"><\/span>\n                    How long does it take to get an Import Licence?<br \/>\n                <span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"font-size:16px; line-height:1.7;\">\n                    Timeline depends on completeness of documents, class of device and whether overseas inspection is required. With proper documentation, the process is usually faster for devices already approved in regulated markets.\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                    Obtaining an Import Licence requires accurate documentation, correct classification, and proper coordination with CDSCO.\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 importers and foreign 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>Authorised Agent services<\/li>\n<li>Preparation of complete documentation for Form MD-14<\/li>\n<li>Free Sale Certificate and Power of Attorney guidance<\/li>\n<li>Liaison with CDSCO<\/li>\n<li>Support for residual shelf-life compliance<\/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_Import_Licence\"><\/span>Need Expert Assistance for Your Import 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>An Import Licence is mandatory if you want to import medical devices into India under the Medical Devices Rules, 2017 (MDR 2017). The licence is granted by the Central Licensing Authority (CLA) under CDSCO in Form MD-15. This detailed guide covers the complete process \u2014 from classification to licence grant \u2014 so you can apply [&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":[139,34,68],"class_list":["post-1024","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home","category-medical-device-regulations-global-compliance","tag-iso-13485","tag-medical-device","tag-regulatory-requirements"],"_links":{"self":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1024","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=1024"}],"version-history":[{"count":2,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1024\/revisions"}],"predecessor-version":[{"id":1028,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/1024\/revisions\/1028"}],"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=1024"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/categories?post=1024"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/tags?post=1024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}