{"id":8395,"date":"2025-08-25T19:49:40","date_gmt":"2025-08-25T19:49:40","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8395"},"modified":"2025-08-26T09:10:03","modified_gmt":"2025-08-26T09:10:03","slug":"cdsco-dermatological-plastic-surgery-medical-devices-license","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/","title":{"rendered":"How to Get CDSCO Dermatological &#038; Plastic Surgery Medical Devices License"},"content":{"rendered":"<p style=\"text-align: justify;\">Manufacturers and Importers of dermatological and plastic surgery medical devices must comply with the rules of the Central Drugs Standard Control Organization (CDSCO) to market their products in India. In its absence, the safety, quality, and performance of these devices cannot be ascertained. As a result, you don&#8217;t get the license to sell them. For medical devices classified as Class A or B, the manufacturing license is issued by the State Licensing Authority (SLA), while for Class C and D devices, it is issued by the Central Drugs Standard Control Organization (CDSCO). However, for the import of devices across all classes (A, B, C, and D), the Central Drugs Standard Control Organization (CDSCO) is the responsible authority.<\/p>\n<p style=\"text-align: justify;\">In this post, we&#8217;ll explain the whole process for obtaining the Medical Device license for Dermatological and Plastic Surgery devices and how Dueran Consultant helps make it seamless.<\/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-dermatological-plastic-surgery-medical-devices-license\/#What_is_a_CDSCO_Medical_Device_License_for_Dermatological_and_Plastic_Surgery_Devices\" >What is a CDSCO Medical Device License for Dermatological and Plastic Surgery 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-dermatological-plastic-surgery-medical-devices-license\/#CDSCO_Classification_of_Dermatological_and_Plastic_Surgery_Devices\" >CDSCO Classification of Dermatological and Plastic Surgery Devices<\/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-dermatological-plastic-surgery-medical-devices-license\/#Classification_of_Medical_Devices_Pertaining_to_Dermatological_Plastic_Surgery\" >Classification of Medical Devices Pertaining to Dermatological &amp; Plastic Surgery<\/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-dermatological-plastic-surgery-medical-devices-license\/#Types_of_Licenses_for_Dermatological_and_Plastic_Surgery_Medical_Devices_in_India\" >Types of Licenses for Dermatological and Plastic Surgery 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-5\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/#Process_for_Dermatological_and_Plastic_Surgery_Medical_Devices_License_Approval\" >Process for Dermatological and\u00a0 Plastic Surgery Medical Devices License Approval<\/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-dermatological-plastic-surgery-medical-devices-license\/#1_Device_Identification_Classification\" >1. Device Identification &amp; Classification<\/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-dermatological-plastic-surgery-medical-devices-license\/#2_Appointment_of_Indian_Authorized_Agent_IAA\" >2. Appointment of Indian Authorized Agent (IAA)<\/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-dermatological-plastic-surgery-medical-devices-license\/#3_Documentation_Preparation\" >3. Documentation Preparation<\/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-dermatological-plastic-surgery-medical-devices-license\/#4_Online_Application_Submission\" >4. Online Application Submission<\/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-dermatological-plastic-surgery-medical-devices-license\/#5_Application_Review_Audit\" >5. Application Review &amp; Audit<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/#6_Grant_of_License\" >6. Grant of License<\/a><\/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:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/#Fee_for_CDSCO_License_for_Plastic_Surgery_and_Dermatological_Products\" >Fee for CDSCO License for Plastic Surgery and Dermatological Products<\/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-dermatological-plastic-surgery-medical-devices-license\/#Steps_for_Manufacturers_Importers_for_Registering_on_the_CDSCO_Medical_Devices_Sugam_Portal\" >Steps for Manufacturers &amp; Importers for Registering on the CDSCO Medical Devices Sugam Portal<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/#Recent_Changes_in_CDSCO_Guidelines\" >Recent Changes in CDSCO Guidelines<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-dermatological-plastic-surgery-medical-devices-license\/#How_Dueran_Consultant_Helps_with_the_Smooth_CDSCO_Licensing_Process\" >How Dueran Consultant Helps with the Smooth CDSCO Licensing Process<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_is_a_CDSCO_Medical_Device_License_for_Dermatological_and_Plastic_Surgery_Devices\"><\/span>What is a CDSCO <span style=\"color: #2490eb;\">Medical Device License<\/span> for Dermatological and Plastic Surgery Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">A Medical Devices license for Dermatological and Plastic Surgery devices is a mandatory approval from the Central Drugs Standard Control Organization or the concerned State Licensing Authority. This means that you can manufacture, import, sell, and distribute medical devices used in dermatological and plastic surgery in India after obtaining the required approval. This approval means that you are compliant with the Medical Device Rules, 2017. Doing so ensures that your device is safe and efficient for the intended user.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CDSCO_Classification_of_Dermatological_and_Plastic_Surgery_Devices\"><\/span>CDSCO Classification of <span style=\"color: #2490eb;\">Dermatological and Plastic Surgery<\/span> Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">To obtain a CDSCO medical device license, knowing device classification is significant. The four categories include Class A, B, C, and D, and each is based on the level of risk and intended use. The table below shows dermatological and plastic surgery Medical devices classification and their respective issuing licensing authority.<\/p>\n<div class=\"container table-responsive py-5\">\n<table width=\"615\">\n<tbody>\n<tr>\n<td style=\"text-align: center;\" width=\"120\"><strong>Type of License<\/strong><\/td>\n<td style=\"text-align: center;\" width=\"95\"><strong>Device Class<\/strong><\/td>\n<td style=\"text-align: center;\" width=\"110\"><strong>Risk Level<\/strong><\/td>\n<td style=\"text-align: center;\" width=\"162\"><strong>Licensing Authority<\/strong><\/td>\n<td style=\"text-align: center;\" width=\"128\"><strong>Required Licenses<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"120\">Manufacturing License<\/td>\n<td width=\"95\">Class A and B<\/td>\n<td width=\"110\">Low to Moderate<\/td>\n<td width=\"162\">State Licensing Authority (SLA)<\/td>\n<td width=\"128\">Form MD 5\/ Form MD 6<\/td>\n<\/tr>\n<tr>\n<td width=\"120\">Manufacturing License<\/td>\n<td width=\"95\">Class C and D<\/td>\n<td width=\"110\">Moderate to High<\/td>\n<td width=\"162\">CDSCO (Central Licensing Authority)<\/td>\n<td width=\"128\">Form MD 9\/ Form MD 10<\/td>\n<\/tr>\n<tr>\n<td width=\"120\">Import License<\/td>\n<td width=\"95\">Class A\/B\/C\/D<\/td>\n<td width=\"110\">Low to High<\/td>\n<td width=\"162\">CDSCO (Central Licensing Authority)<\/td>\n<td width=\"128\">Form MD 15<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_Pertaining_to_Dermatological_Plastic_Surgery\"><\/span><strong>Classification of Medical Devices Pertaining to <span style=\"color: #2490eb;\">Dermatological &amp; Plastic Surgery<\/span><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">All the products used in various clinical procedures related to dermatological and plastic surgery are classified as follows:<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<tbody>\n<tr>\n<td width=\"64\">\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=\"336\"><span style=\"color: #2490eb;\"><strong>Medical Device Name<\/strong><\/span><\/td>\n<td width=\"63\">\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=\"64\">1<\/td>\n<td width=\"336\">Organ bag<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">2<\/td>\n<td width=\"336\">Surgical camera and accessories<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">3<\/td>\n<td width=\"336\">Implantable ligating clip<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">4<\/td>\n<td width=\"336\">Laser surgical instrument for use in general and plastic surgery and in dermatology<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">5<\/td>\n<td width=\"336\">Low-energy ultrasound wound cleaner<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">6<\/td>\n<td width=\"336\">Non-powdered surgeon&#8217;s glove<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">7<\/td>\n<td width=\"336\">Surgical drape and drape accessories<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">8<\/td>\n<td width=\"336\">Suture retention device<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">9<\/td>\n<td width=\"336\">Ultraviolet lamp for dermatologic disorders<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">10<\/td>\n<td width=\"336\">Wound auto fluorescence imaging device<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">11<\/td>\n<td width=\"336\">Battery-powered trephine system<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">12<\/td>\n<td width=\"336\">Carbon dioxide laser<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">13<\/td>\n<td width=\"336\">Colonoscope, General &amp; Plastic Surgery<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">14<\/td>\n<td width=\"336\">Copper vapour laser<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">15<\/td>\n<td width=\"336\">Cryosurgical unit and accessories<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">16<\/td>\n<td width=\"336\">Dermal dilator<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">17<\/td>\n<td width=\"336\">Dermatome<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">18<\/td>\n<td width=\"336\">Dermatome skin approximation tape<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">19<\/td>\n<td width=\"336\">Drape adhesive<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">20<\/td>\n<td width=\"336\">Electrically powered trephine system<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">21<\/td>\n<td width=\"336\">Electrosurgical cutting and coagulation device<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">22<\/td>\n<td width=\"336\">Electrosurgical device for over-the-counter aesthetic use<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">23<\/td>\n<td width=\"336\">Esophagoscope, General &amp; Plastic Surgery<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">24<\/td>\n<td width=\"336\">Eye pad<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">25<\/td>\n<td width=\"336\">Gas-powered dermatome<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">26<\/td>\n<td width=\"336\">Gas-powered surgical saw<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">27<\/td>\n<td width=\"336\">Gas-powered trephine system<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">28<\/td>\n<td width=\"336\">Gastroscope, General &amp; Plastic Surgery<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">29<\/td>\n<td width=\"336\">General electrosurgical unit<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">30<\/td>\n<td width=\"336\">Hemostatic knife<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">31<\/td>\n<td width=\"336\">Hydrophilic wound dressing<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">32<\/td>\n<td width=\"336\">Implantable staple<\/td>\n<td width=\"63\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">33<\/td>\n<td width=\"336\">Internal tissue marker<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">34<\/td>\n<td width=\"336\">Irrigating wound retractor device<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">35<\/td>\n<td width=\"336\">Laparoscope, General &amp; Plastic Surgery<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">36<\/td>\n<td width=\"336\">Laparoscopy Tray<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">37<\/td>\n<td width=\"336\">Liposuction catheter<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">38<\/td>\n<td width=\"336\">Manual operating table and accessories, and manual operating chair and accessories<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">39<\/td>\n<td width=\"336\">Manually-operated dermatome<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">40<\/td>\n<td width=\"336\">Occlusive wound dressing<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">41<\/td>\n<td width=\"336\">Plastic surgery osteotome<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">42<\/td>\n<td width=\"336\">Powered corneal trephine<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">43<\/td>\n<td width=\"336\">Powered dermatome<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">44<\/td>\n<td width=\"336\">Powered suction pump<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">45<\/td>\n<td width=\"336\">Removable skin clip<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">46<\/td>\n<td width=\"336\">Removable skin staple<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">47<\/td>\n<td width=\"336\">Reusable dermatome blade<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">48<\/td>\n<td width=\"336\">Single-use dermatome blade<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">49<\/td>\n<td width=\"336\">Skin marker<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">50<\/td>\n<td width=\"336\">Skin Stapler<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">51<\/td>\n<td width=\"336\">Soft tissue trephine<\/td>\n<td width=\"63\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">52<\/td>\n<td width=\"336\">Surgical apparel<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">53<\/td>\n<td width=\"336\">Surgical guillotine<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">54<\/td>\n<td width=\"336\">Surgical lamp<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\">55<\/td>\n<td width=\"336\">Surgical microscope and accessories<\/td>\n<td width=\"63\">A<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2><\/h2>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Types_of_Licenses_for_Dermatological_and_Plastic_Surgery_Medical_Devices_in_India\"><\/span>Types of Licenses for Dermatological and Plastic Surgery <span style=\"color: #2490eb;\">Medical Devices in India<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Licensing requirements differ according to your needs. Specific licenses are required by the manufacturers and importers, depending upon the class of your device.<\/p>\n<ul style=\"text-align: justify;\">\n<li>Form MD-5 &amp; Form MD-6 license is a prerequisite for producing or manufacturing Class A and B dermatological and plastic surgery devices, which is issued by the State Licensing Authority.<\/li>\n<li>Form MD-9 &amp; Form MD-10 license, issued by CDSCO, is for producing Class C and D devices.<\/li>\n<li>Foreign manufacturers who want to import products in India should first submit Form MD-14. A successful review of this form will get you the approval in the form of the MD 15 import license for all Classes of Medical devices (Class A, B, C, and D).<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Process_for_Dermatological_and_Plastic_Surgery_Medical_Devices_License_Approval\"><\/span>Process for Dermatological and\u00a0 Plastic Surgery <span style=\"color: #2490eb;\">Medical Devices License<\/span> Approval<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">To obtain a medical device license, you must first determine its risk class and then prepare the necessary documents in the correct format. If you need guidance or assistance at any step, our team at Dueran Consultant is here for you.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"1_Device_Identification_Classification\"><\/span><span style=\"color: #2490eb;\">1.<\/span> Device Identification &amp; Classification<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Verify if your device is notified or non-notified (i.e., not strictly regulated by the CDSCO). Then, classify the device (A, B, C, or D) based on risk and intended usage.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"2_Appointment_of_Indian_Authorized_Agent_IAA\"><\/span><span style=\"color: #2490eb;\">2.<\/span> Appointment of Indian Authorized Agent (IAA)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For foreign manufacturers, an IAA represents you in India. The IAA must have the Wholesale license or registration Certificate (Form MD-42) for selling the device. Additionally, the authorisation you grant to the IAA must be documented by a power of attorney.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"3_Documentation_Preparation\"><\/span><span style=\"color: #2490eb;\">3.<\/span> Documentation Preparation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Preparing documents is the most significant step in obtaining the CDSCO License for dermatological and plastic surgery devices. It is a lengthy and meticulous process that is prone to errors. The following documents are essential:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Application Form (With product and applicant details)<\/li>\n<li>Challan TR6 (Fee payment proof)<\/li>\n<li>ISO 13485 Certificate (Quality Management System Certificate)<\/li>\n<li>Power of Attorney (For foreign manufacturers)<\/li>\n<li>Required Undertakings as per Medical Devices Rules, 2017<\/li>\n<li>CE Certificate (if applicable)<\/li>\n<li>Free Sale Certificate<\/li>\n<li>Plant Master File &amp; Device Master File<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"4_Online_Application_Submission\"><\/span><span style=\"color: #2490eb;\">4.<\/span> Online Application Submission<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">After preparing the documents, visit the CDSCO Medical Device SUGAM Portal. Register on the site with a valid email and confirm it via the link sent to your email. This will activate your account, and the verification process will begin. After verification, submit the relevant forms on the portal and upload all required documents.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"5_Application_Review_Audit\"><\/span><span style=\"color: #2490eb;\">5.<\/span> Application Review &amp; Audit<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">CDSCO reviews the application you have submitted. It will also conduct a facility audit. If it identifies any Non-Conformance (NC) issues, you must address them.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"6_Grant_of_License\"><\/span><span style=\"color: #2490eb;\">6.<\/span> Grant of License<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Upon successful review, CDSCO will issue the license, which remain valid in perpetuity, unless it has been cancelled or surrendered, provided the licence holder deposits the licence retention fee every five years.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Fee_for_CDSCO_License_for_Plastic_Surgery_and_Dermatological_Products\"><\/span>Fee for CDSCO License for <span style=\"color: #2490eb;\">Plastic Surgery and Dermatological Products<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul style=\"text-align: justify;\">\n<li>The Government fee for Class A and B medical devices for domestic manufacturers is Rs. 5,000 for one site and Rs. 500 for each medical device.<\/li>\n<li>The Government fee for Class C and D medical devices for domestic manufacturers is Rs. 50,000 for one site and Rs. 1,000 for each medical device.<\/li>\n<li>The Government fee for an Import License of Class A medical devices is USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device.<\/li>\n<li>The Government fee for an Import License of Class B medical devices is USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.<\/li>\n<li>The Government fee for Import License of Class C &amp; D medical devices is USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Steps_for_Manufacturers_Importers_for_Registering_on_the_CDSCO_Medical_Devices_Sugam_Portal\"><\/span>Steps for <span style=\"color: #2490eb;\">Manufacturers &amp; Importers<\/span> for Registering on the CDSCO Medical Devices Sugam Portal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><strong>The process for registration is as follows:<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>On your browser, go to <a href=\"https:\/\/cdscomdonline.gov.in\/NewMedDev\/Homepage\">https:\/\/cdscomdonline.gov.in\/NewMedDev\/Homepage<\/a><\/li>\n<li>Tap the registration link from the portal.<\/li>\n<li>Use a valid email ID and contact number to register.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>Submit the following documents:<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>Your ID proofs<\/li>\n<li>An Affidavit<\/li>\n<li>Your corporate address proofs<\/li>\n<li>A copy of your manufacturing or wholesale licenses.<\/li>\n<li>Validate registration via OTP.<\/li>\n<li>Now, you can log in and start your application process.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Recent_Changes_in_CDSCO_Guidelines\"><\/span>Recent Changes in <span style=\"color: #2490eb;\">CDSCO<\/span> Guidelines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">This year, CDSCO has put in place some new processes for manufacturers and importers of medical devices. These include:<\/p>\n<ul style=\"text-align: justify;\">\n<li>System auto-generated Neutral Code: Manufacturers with a valid license can get a Neutral Code for export, directly via the Medical Devices Online Portal. It eased up with the earlier manual issuance method set up by the Licensing Authority.<\/li>\n<li>Auto-generation of Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC): The new auto-generation mechanism for MSC and NCC certificates for licensed medical devices. If you have applied through the previous portal, you must reapply to get the auto-generated certificates.<\/li>\n<li>Re-classification of risk class: Many devices have undergone risk re-classification. Review the updated table for reclassified devices given earlier in this post.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_Dueran_Consultant_Helps_with_the_Smooth_CDSCO_Licensing_Process\"><\/span>How <span style=\"color: #2490eb;\">Dueran Consultant<\/span> Helps with the Smooth CDSCO Licensing Process<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Challenges with the classification of devices, documentation, and keeping updated with the rules of CDSCO are common for importers and manufacturers. We provide customised regulatory solutions to help you get the license without delay. Beyond solving typical issues, we also create a regulatory strategy to open up potential opportunities for you to sell and grow your brand in India.<\/p>\n<p style=\"text-align: justify;\">Contact us anytime to get proactive support for dermatological and plastic surgery device approval.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Manufacturers and Importers of dermatological and plastic surgery medical devices must comply with the rules of the Central Drugs Standard<\/p>\n","protected":false},"author":1,"featured_media":8404,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[625,627,629,626,628,630],"class_list":["post-8395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-dermatological-plastic-surgery-medical-devices","tag-cdsco-dermatological-medical-devices","tag-cdsco-license-for-dermatological","tag-cdsco-license-for-dermatological-and-plastic-surgery","tag-cdsco-license-for-dermatological-and-plastic-surgery-product","tag-cdsco-medical-device-import-license-for-dermatologists"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dermatological and Plastic Surgery Medical Devices[In-depth Info]<\/title>\n<meta name=\"description\" content=\"Complete process for getting a CDSCO license for Dermatological and Plastic Surgery Medical Devices. 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