{"id":8440,"date":"2025-09-28T12:29:19","date_gmt":"2025-09-28T12:29:19","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8440"},"modified":"2025-09-28T12:45:46","modified_gmt":"2025-09-28T12:45:46","slug":"cdsco-physical-support-medical-devices-license","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/","title":{"rendered":"CDSCO Physical Support Medical Devices License &#8211; Process, Documents, Classification"},"content":{"rendered":"<p style=\"text-align: justify;\">Understanding the process of getting a CDSCO physical support medical devices license is significant for both manufacturers and importers. This license, mandated by the Central Drugs Standard Control Organization (<a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" target=\"_blank\" rel=\"nofollow noopener\">CDSCO<\/a>), ensures that physical support medical devices meet the quality and safety standards before they enter the market. The process of achieving this is lengthy and may confuse you if this is your first time. But in this post, we&#8217;ll explain in detail how to get the manufacturing and import physical support medical devices license in India.<\/p>\n<p>&nbsp;<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#What_are_Physical_Support_Medical_Devices\" >What are Physical Support 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:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#Risk_Classes_of_Physical_Support_Medical_Devices_by_CDSCO\" >Risk Classes of Physical Support Medical Devices by CDSCO<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#CDSCO_Classification_of_Physical_Support_Medical_Devices\" >CDSCO Classification of Physical Support Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#Types_of_CDSCO_Licenses_for_Physical_Support_Devices\" >Types of CDSCO Licenses for Physical Support 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:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#Application_Process_for_CDSCO_License_for_Physical_Support_Medical_Devices\" >Application Process for CDSCO License for Physical Support Medical Devices<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#1_Classification_of_the_Device\" >1. Classification of the Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#2_Application_for_Manufacturing_License_For_Indian_Manufacturers\" >2. Application for Manufacturing License (For Indian Manufacturers)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#3_Application_for_Import_License_For_Foreign_Manufacturers\" >3. Application for Import License (For Foreign Manufacturers)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#4_Submit_the_Application_Through_the_Medical_Device_Sugam_Portal\" >4. Submit the Application Through the Medical Device Sugam Portal<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#5_Documentation_Preparation\" >5. Documentation Preparation<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#Fee_for_Manufacturing_and_Importing_Physical_Support_Medical_Devices_in_India\" >Fee for Manufacturing and Importing Physical Support Medical Devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#How_to_Report_Post-Approval_Changes_in_Physical_Support_Medical_Device\" >How to Report Post-Approval Changes in Physical Support Medical Device?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/#How_Dueran_Consultant_Helps_You\" >How Dueran Consultant Helps You?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_are_Physical_Support_Medical_Devices\"><\/span>What are <span style=\"color: #2490eb;\">Physical Support<\/span> Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Physical support medical devices are different types of equipment designed to stabilise or support the body physically for individuals who have difficulty in moving or maintaining posture independently. They provide structural or functional support to specific body parts. Common examples of such devices include orthosis, Shoulder immobilizer, Orthopaedic bed and the like.<\/p>\n<p style=\"text-align: justify;\">The Physical support medical devices fall under the regulatory frameworks of the CDSCO and the respective state licensing authorities in India. The license by the issuing authority ensures that your devices and equipment meet safety and quality standards before clinicians use them for their patients or for conducting research.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Risk_Classes_of_Physical_Support_Medical_Devices_by_CDSCO\"><\/span>Risk Classes of <span style=\"color: #2490eb;\">Physical Support Medical Devices<\/span> by CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Before you understand the approval process for the CDSCO physical support medical devices license, you must be aware of the risk class of your device. All physical support medical devices fall under Four classes, i.e., Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (High risk). Some examples of Class A medical devices for physical support are an orthopaedic bed, a walking frame, and a shoulder immobiliser.<\/p>\n<p style=\"text-align: justify;\">Likewise, Class B medical devices with low-moderate risk are equipment like a physical therapy massager and a traction table. An example of a Class C medical device is a neuro-controlled ambulation exoskeleton and Class D is Cervical spine immobilization head ring.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CDSCO_Classification_of_Physical_Support_Medical_Devices\"><\/span>CDSCO <span style=\"color: #2490eb;\">Classification<\/span> of Physical Support Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The table below gives the latest classification of physical support devices:<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<tbody>\n<tr>\n<td width=\"51\">\n<p style=\"text-align: center;\"><span style=\"color: #2490eb;\"><strong>S. No<\/strong><\/span><\/p>\n<\/td>\n<td style=\"text-align: center;\" width=\"261\"><span style=\"color: #2490eb;\"><strong>Name of the Medical Devices<\/strong><\/span><\/td>\n<td width=\"76\">\n<p style=\"text-align: center;\"><span style=\"color: #2490eb;\"><strong>Risk Class<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">1<\/td>\n<td width=\"261\">Ankle continuous passive motion exerciser<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">2<\/td>\n<td width=\"261\">Ankle\/foot orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">3<\/td>\n<td width=\"261\">Balance board<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">4<\/td>\n<td width=\"261\">Bed traction frame<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">5<\/td>\n<td width=\"261\">Body arch traction table<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">6<\/td>\n<td width=\"261\">Canalith repositioning procedure chair, manual<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">7<\/td>\n<td width=\"261\">Cervical spine collar<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">8<\/td>\n<td width=\"261\">Cervical spine immobilization head ring<\/td>\n<td width=\"76\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">9<\/td>\n<td width=\"261\">Cervicothoracic spine orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">10<\/td>\n<td width=\"261\">Cervicothoracolumbosacral spine orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">11<\/td>\n<td width=\"261\">Chest-oscillation airway secretion clearing system<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">12<\/td>\n<td width=\"261\">Collar and cuff arm sling material<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">13<\/td>\n<td width=\"261\">Cranial orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">14<\/td>\n<td width=\"261\">Elbow orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">15<\/td>\n<td width=\"261\">Finger orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">16<\/td>\n<td width=\"261\">Flotation therapy bed, adult<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">17<\/td>\n<td width=\"261\">Flotation therapy bed, neonatal<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">18<\/td>\n<td width=\"261\">Foot orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">19<\/td>\n<td width=\"261\">Hand orthosis<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">20<\/td>\n<td width=\"261\">Hand\/finger splint<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">21<\/td>\n<td width=\"261\">Hand\/wrist continuous passive motion exerciser<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">22<\/td>\n<td width=\"261\">Hip\/knee continuous passive motion exerciser<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">23<\/td>\n<td width=\"261\">Horizontal non-powered traction system<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">24<\/td>\n<td width=\"261\">Incentive spirometer<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">25<\/td>\n<td width=\"261\">Intermittent traction system<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">26<\/td>\n<td width=\"261\">Kinetic bed<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">27<\/td>\n<td width=\"261\">Knee immobilizer<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">28<\/td>\n<td width=\"261\">Neuro-controlled ambulation exoskeleton<\/td>\n<td width=\"76\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">29<\/td>\n<td width=\"261\">Orthopaedic bed<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">30<\/td>\n<td width=\"261\">Paediatric dorsiflexion slant board<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">31<\/td>\n<td width=\"261\">Parapodium walking frame<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">32<\/td>\n<td width=\"261\">Physical therapy massager<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">33<\/td>\n<td width=\"261\">Shoulder continuous passive motion exerciser<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">34<\/td>\n<td width=\"261\">Shoulder immobilizer<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">35<\/td>\n<td width=\"261\">Swivel-walker<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">36<\/td>\n<td width=\"261\">Toe separator<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">37<\/td>\n<td width=\"261\">Traction table, line- powered<\/td>\n<td width=\"76\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"51\">38<\/td>\n<td width=\"261\">Wrist immobilizer<\/td>\n<td width=\"76\">A<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Types_of_CDSCO_Licenses_for_Physical_Support_Devices\"><\/span>Types of <span style=\"color: #2490eb;\">CDSCO Licenses<\/span> for Physical Support Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Different licenses are required for manufacturing, importing, Test, and for clinical investigation. Your application for a license should match the specific license you need.<\/p>\n<ul style=\"text-align: justify;\">\n<li>Manufacturing License: The Form MD-5 license is required for manufacturing of Class A &amp; B devices. Form MD-9 is needed to manufacture of Class C &amp; D physical support devices.<\/li>\n<li>Import License: The Form MD-15 license is required for importing medical devices of all classes.<\/li>\n<li>Loan License: The loan license is needed to manufacture devices using another manufacturer&#8217;s facility.\u00a0The Form MD-6 is loan license for manufacturing of Class A &amp; B devices. Form MD-10 is loan license for manufacturing of Class C &amp; D physical support devices.<\/li>\n<li>Test License: The Form MD-13 test license is crucial for manufacturing a limited quantity of devices for testing, Clinical investigation, Demonstration, Training, Test &amp; evaluation. Similarly, Form MD-17 test license is required for importing such devices.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Application_Process_for_CDSCO_License_for_Physical_Support_Medical_Devices\"><\/span>Application <span style=\"color: #2490eb;\">Process for CDSCO License<\/span> for Physical Support Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">To obtain a CDSCO registration for Physical support medical devices for manufacturing and import licenses, follow these detailed steps aligned with the latest rules in India.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"1_Classification_of_the_Device\"><\/span><span style=\"color: #2490eb;\">1.<\/span> Classification of the Device<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">First, classify your physical support medical device according to CDSCO&#8217;s risk-based classes (A, B, C, or D), which have already been mentioned in the previous sections. It will determine the risk profile according to the intended use of your device.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"2_Application_for_Manufacturing_License_For_Indian_Manufacturers\"><\/span><span style=\"color: #2490eb;\">2.<\/span> Application for Manufacturing License (For Indian Manufacturers)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For Class A &amp; B devices, Indian manufacturers should apply to the State Licensing Authority (SLA). This needs you to fill out Form MD-3 and the license will be issued as MD-5.<\/p>\n<p style=\"text-align: justify;\">For Class C &amp; D devices, apply to the Central Licensing Authority (CLA) using Form MD-7. Your license will be issued as MD-9. Also, your manufacturing facility need to be compliant with ISO 13485:2016 standards for quality management systems, as CDSCO abides by QMS.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"3_Application_for_Import_License_For_Foreign_Manufacturers\"><\/span><span style=\"color: #2490eb;\">3.<\/span> Application for Import License (For Foreign Manufacturers)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">To get an import license for physical support medical devices, foreign manufacturers should appoint an Indian Authorised Agent (IAA). Such an entity or person must have a valid wholesale\/manufacturing license.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"4_Submit_the_Application_Through_the_Medical_Device_Sugam_Portal\"><\/span><span style=\"color: #2490eb;\">4.<\/span> Submit the Application Through the Medical Device Sugam Portal<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Medical Device SUGAM is an e-governance platform developed by CDSCO. It is used for CDSCO registration for physical support medical devices, tracking submission status, and communication with CDSCO. Activate your account on this portal to submit the needed documents.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"5_Documentation_Preparation\"><\/span><span style=\"color: #2490eb;\">5.<\/span> Documentation Preparation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Prepare and submit complete technical documentation:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Device Master File<\/li>\n<li>Plant Master File<\/li>\n<li>ISO 13485 certificate<\/li>\n<li>CE certificate<\/li>\n<li>Declaration of Conformity<\/li>\n<li>Free Sale Certificate\/ Certificate to foreign government (CFG issued by US FDA)<\/li>\n<li>Legalised Power of Attorney<\/li>\n<li>An undertaking that you have provided the correct information<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Fee_for_Manufacturing_and_Importing_Physical_Support_Medical_Devices_in_India\"><\/span>Fee for Manufacturing and Importing <span style=\"color: #2490eb;\">Physical Support Medical Devices in India<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The regulatory fees in India for the manufacture and Import of physical support medical devices are set according to the device class under the Medical Devices Rules, 2017:<\/p>\n<div class=\"container table-responsive py-5\">\n<table width=\"615\">\n<tbody>\n<tr>\n<td width=\"131\">\n<p style=\"text-align: center;\"><span style=\"color: #2490eb;\"><strong>Device Class<\/strong><\/span><\/p>\n<\/td>\n<td style=\"text-align: center;\" width=\"199\"><span style=\"color: #2490eb;\"><strong>Government Fees<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"159\"><span style=\"color: #2490eb;\"><strong>Licensing Authority<\/strong><\/span><\/td>\n<td width=\"127\">\n<p style=\"text-align: center;\"><span style=\"color: #2490eb;\"><strong>Required Licenses<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"131\"><strong>Manufacturing License<\/strong><\/td>\n<td width=\"199\"><\/td>\n<td width=\"159\"><\/td>\n<td width=\"127\"><\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class A<\/td>\n<td width=\"199\">Rs. 5,000 for one site and Rs. 500 for each medical device.<\/td>\n<td width=\"159\">State Licensing Authority (SLA)<\/td>\n<td rowspan=\"2\" width=\"127\">Form MD 5\/ Form MD 6<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class B<\/td>\n<td width=\"199\">Rs. 5,000 for one site and Rs. 500 for each medical device.<\/td>\n<td width=\"159\">State Licensing Authority (SLA)<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class C<\/td>\n<td width=\"199\">Rs. 50,000 for one site and Rs. 1,000 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<td rowspan=\"2\" width=\"127\">Form MD 9\/ Form MD 10<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class D<\/td>\n<td width=\"199\">Rs. 50,000 for one site and Rs. 1,000 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"131\"><strong>Import License<\/strong><\/td>\n<td width=\"199\"><\/td>\n<td width=\"159\"><\/td>\n<td width=\"127\"><\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class A<\/td>\n<td width=\"199\">USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<td rowspan=\"4\" width=\"127\">Form MD 15<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class B<\/td>\n<td width=\"199\">USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class C<\/td>\n<td width=\"199\">USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"131\">Class D<\/td>\n<td width=\"199\">USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.<\/td>\n<td width=\"159\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"text-align: justify;\"><em>*Note that this license is valid for 5 years and is renewable with a retention fee before expiry.<\/em><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_to_Report_Post-Approval_Changes_in_Physical_Support_Medical_Device\"><\/span>How to Report <span style=\"color: #2490eb;\">Post-Approval Changes<\/span> in Physical Support Medical Device?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">According to CDSCO, Post Approval Changes must be reported to the licensing authority which includes but not limited to following:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Construction material<\/li>\n<li>Design that impacts the quality of the device<\/li>\n<li>Performance and stability of the equipment<\/li>\n<li>Purpose or use<\/li>\n<li>Sterilization method<\/li>\n<li>Official shelf life<\/li>\n<li>The name or address of the Indian manufacturer or its manufacturing site<\/li>\n<li>\u00a0The name or address of the Overseas manufacturer or its manufacturing site (for importers)<\/li>\n<li>Change in the Indian authorized agent.<\/li>\n<li>Change in label<\/li>\n<li>Manufacturing process or testing that impact\u2019s the performance or quality of the device<\/li>\n<li>Packaging material<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">To report the changes, you must prepare the updated documents. It should have the updated specifications, risk assessments, test results, packaging designs, and SOP\u2019s. After that, submit the application to CDSCO under the Post Approval Changes category.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_Dueran_Consultant_Helps_You\"><\/span>How <span style=\"color: #2490eb;\">Dueran Consultant<\/span> Helps You?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Our team offers specialised regulatory consulting to help manufacturers and importers secure CDSCO physical support medical device licenses with ease. The licensing process may look easy, but it is complex and needs due diligence. We help make it easier for our clients through end-to-end support and guidance with form submissions, documentation, and interactions with the issuing authorities for both manufacturing and import permits.<\/p>\n<p style=\"text-align: justify;\">Our <strong><a href=\"https:\/\/www.dueranconsultancy.com\/\">Dueran consultant<\/a><\/strong> experts handle applications for Low to moderate &amp; moderate to high-risk devices. We provide complete support for notified and non-notified medical devices. Contact us anytime to book a free consultation for your case.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Understanding the process of getting a CDSCO physical support medical devices license is significant for both manufacturers and importers. This<\/p>\n","protected":false},"author":1,"featured_media":8441,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[659,656,653,654,655,657,658],"class_list":["post-8440","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-classification-of-physical-support-medical-devices","tag-cdsco-license-for-physical-support-medical-devices","tag-cdsco-physical-support-medical-devices","tag-cdsco-physical-support-medical-devices-license","tag-cdsco-registration-for-physical-support-medical-devices","tag-import-physical-support-medical-devices-license","tag-physical-support-medical-devices-in-india"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CDSCO Physical Support Medical Devices License - [Process]<\/title>\n<meta name=\"description\" content=\"Find the detailed process to obtain a CDSCO physical support medical devices license and learn how Dueran Consultant makes it easy.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDSCO Physical Support Medical Devices License - [Process]\" \/>\n<meta property=\"og:description\" content=\"Find the detailed process to obtain a CDSCO physical support medical devices license and learn how Dueran Consultant makes it easy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-physical-support-medical-devices-license\/\" \/>\n<meta property=\"og:site_name\" content=\"Blog Insights on Medical Regulatory Services\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-28T12:29:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-28T12:45:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.dueranconsultancy.com\/blog\/wp-content\/uploads\/2025\/09\/CDSCO-Physical-Support-Medical-Devices.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"450\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.dueranconsultancy.com\\\/blog\\\/cdsco-physical-support-medical-devices-license\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.dueranconsultancy.com\\\/blog\\\/cdsco-physical-support-medical-devices-license\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/www.dueranconsultancy.com\\\/blog\\\/#\\\/schema\\\/person\\\/d04ad734c45d4ef8aa9a7dccc3717a86\"},\"headline\":\"CDSCO Physical Support Medical Devices License &#8211; 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