{"id":8479,"date":"2026-01-26T14:59:11","date_gmt":"2026-01-26T14:59:11","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8479"},"modified":"2026-01-26T14:59:11","modified_gmt":"2026-01-26T14:59:11","slug":"cdsco-paediatrics-neonatology-medical-devices-licensing-in-india","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/","title":{"rendered":"CDSCO Paediatrics &#038; Neonatology Medical Devices Licensing in India"},"content":{"rendered":"<p style=\"text-align: justify;\">India has a growing demand for paediatric and neonatology medical devices, which has made regulatory compliance a top priority for manufacturers and importers. The CDSCO paediatrics and neonatology medical devices license is a requirement that must be met to manufacture, import, or market these products in the country. If you plan to introduce advanced neonatal ventilators or innovative paediatric monitoring systems, understanding how the <a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" rel=\"nofollow\">CDSCO<\/a> framework works is significant.<\/p>\n<p style=\"text-align: justify;\">In this article, we\u2019ll explain the process to procure the CDSCO paediatrics and neonatology license in India. We\u2019ll go over the application process, classification of devices, and the stages for obtaining both manufacturing and import licenses for paediatrics and neonatology medical devices.<\/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-paediatrics-neonatology-medical-devices-licensing-in-india\/#CDSCOs_Role_in_Paediatrics_Neonatology_Medical_Devices\" >CDSCO\u2019s Role in Paediatrics &amp; Neonatology 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-paediatrics-neonatology-medical-devices-licensing-in-india\/#Classification_of_Paediatrics_Neonatology_Medical_Devices\" >Classification of Paediatrics &amp; Neonatology Medical 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-paediatrics-neonatology-medical-devices-licensing-in-india\/#CDSCO_Classification_of_Paediatrics_and_Neonatology_Medical_Devices\" >CDSCO Classification of Paediatrics and Neonatology 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-paediatrics-neonatology-medical-devices-licensing-in-india\/#When_Is_A_CDSCO_Paediatrics_Neonatology_License_Required\" >When Is A CDSCO Paediatrics &amp; Neonatology License Required?<\/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-paediatrics-neonatology-medical-devices-licensing-in-india\/#Import_License_for_Paediatrics_Neonatology_Medical_Devices\" >Import License for Paediatrics &amp; Neonatology Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/#Documentation_for_CDSCO_Paediatrics_Neonatology_Medical_Devices_License_for_Manufacturers_and_Importers\" >Documentation for CDSCO Paediatrics &amp; Neonatology Medical Devices License for Manufacturers and Importers<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/#Steps_to_Obtain_License_for_CDSCO_Paediatrics_Neonatology_Medical_Devices_in_India\" >Steps to Obtain License for CDSCO Paediatrics &amp; Neonatology 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-8\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/#License_and_Application_Fee_for_Medical_Devices\" >License and Application Fee for 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-9\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/#Note_that_this_license_is_valid_for_5_years_and_is_renewable_with_a_retention_fee_before_expiry\" >*Note that this license is valid for 5 years and is renewable with a retention fee before expiry.<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-paediatrics-neonatology-medical-devices-licensing-in-india\/#How_Dueran_Consultant_Helps_You\" >How Dueran Consultant Helps You?<\/a><\/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-paediatrics-neonatology-medical-devices-licensing-in-india\/#Conclusion\" >Conclusion:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CDSCOs_Role_in_Paediatrics_Neonatology_Medical_Devices\"><\/span>CDSCO\u2019s Role in Paediatrics &amp; Neonatology <span style=\"color: #2490eb;\">Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The Central Drugs Standard Control Organization (CDSCO) is India\u2019s national regulatory authority. It oversees the quality, safety, and performance of medical devices. For paediatric and neonatology equipment, such as infant apnoea monitor, incubators and oxygen monitor, this issuing authority makes sure that they abide by the strict safety and performance benchmarks.<\/p>\n<p style=\"text-align: justify;\">The CDSCO paediatrics medical devices license and CDSCO neonatology medical devices license are evidence of your devices being safe and do not cause irritation, infections, or even complications to the vulnerable patient group consisting of infants and children.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Classification_of_Paediatrics_Neonatology_Medical_Devices\"><\/span>Classification of Paediatrics &amp; Neonatology <span style=\"color: #2490eb;\">Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The CDSCO follows a risk-based classification system, which has a great effect on the licensing process. The official CDSCO classification of paediatrics and neonatology Medical Devices determines the right documentation, technical assessments, and the approval timeline.<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<tbody>\n<tr>\n<td style=\"text-align: center;\" width=\"57\"><span style=\"color: #2490eb;\"><strong>S. No<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"255\"><span style=\"color: #2490eb;\"><strong>Name of Product<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"83\"><span style=\"color: #2490eb;\"><strong>Risk Class<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"57\">1<\/td>\n<td width=\"255\">Aerosol tent, paediatric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">2<\/td>\n<td width=\"255\">Airway Pressure \/ Oxygen Monitor<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">3<\/td>\n<td width=\"255\">Anaesthesia Facemask, single use (paediatric)<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">4<\/td>\n<td width=\"255\">Anaesthesia Facemask, reusable (paediatric)<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">5<\/td>\n<td width=\"255\">Antimicrobial endotracheal tube, paediatric<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">6<\/td>\n<td width=\"255\">Assistive ergonomic chair mobility base<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">7<\/td>\n<td width=\"255\">Breathing circuit gas- flow sensor, reusable<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">8<\/td>\n<td width=\"255\">Breathing circuit gas- flow sensor, single- use<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">9<\/td>\n<td width=\"255\">Cerebral oximeter<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">10<\/td>\n<td width=\"255\">Circulating-air whole- body heating\/cooling system pad, reusable<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">11<\/td>\n<td width=\"255\">Circulating-air whole- body heating\/cooling system pad, single- use, sterile<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">12<\/td>\n<td width=\"255\">Circulating-fluid whole-body heating\/cooling system pad, reusable<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">13<\/td>\n<td width=\"255\">Circulating-fluid whole-body heating\/cooling system pad, single- use<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">14<\/td>\n<td width=\"255\">Closed-ended adhesive infant\/paediatric urine collection bag<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">15<\/td>\n<td width=\"255\">Craniofacial bone screw, bioabsorbable<\/td>\n<td width=\"83\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">16<\/td>\n<td width=\"255\">Craniofacial bone screw, non- bioabsorbable, sterile<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">17<\/td>\n<td width=\"255\">Electric pad whole- body heating system<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">18<\/td>\n<td width=\"255\">Electric pad whole- body heating system pad<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">19<\/td>\n<td width=\"255\">Enteral feeding kit, adult\/paediatric, sterile<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">20<\/td>\n<td width=\"255\">Exhaled-gas oesophageal intubation detector, paediatric<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">21<\/td>\n<td width=\"255\">External counterpulsation system, paediatric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">22<\/td>\n<td width=\"255\">External defibrillator electrode, paediatric, reusable<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">23<\/td>\n<td width=\"255\">External defibrillator electrode, paediatric, single-use<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">24<\/td>\n<td width=\"255\">Flexible bone nail, non-sterile<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">25<\/td>\n<td width=\"255\">Flexible bone nail, sterile<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">26<\/td>\n<td width=\"255\">Funnel chest remodelling bar<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">27<\/td>\n<td width=\"255\">Growth-correction orthopaedic fixation plate kit<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">28<\/td>\n<td width=\"255\">Hepatic ultrasound elastography system applicator<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">29<\/td>\n<td width=\"255\">Infant apnoea monitor<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">30<\/td>\n<td width=\"255\">Infant bed crib top<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">31<\/td>\n<td width=\"255\">Infant bed restraint<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">32<\/td>\n<td width=\"255\">Infant care table<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">33<\/td>\n<td width=\"255\">Infant heat shield<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">34<\/td>\n<td width=\"255\">Infant incubator control unit<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">35<\/td>\n<td width=\"255\">Infant incubator warming hood<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">36<\/td>\n<td width=\"255\">Infant inguinal hernia truss<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">37<\/td>\n<td width=\"255\">Infant limb immobilizer, reusable<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">38<\/td>\n<td width=\"255\">Infant limb immobilizer, single- use<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">39<\/td>\n<td width=\"255\">Infant resuscitation cabinet<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">40<\/td>\n<td width=\"255\">Infant resuscitation table<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">41<\/td>\n<td width=\"255\">Infant scale, electronic<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">42<\/td>\n<td width=\"255\">Infant sleep positioner<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">43<\/td>\n<td width=\"255\">Infant warmer<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">44<\/td>\n<td width=\"255\">Infant whole-body immobilizer, reusable<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">45<\/td>\n<td width=\"255\">Infant whole-body immobilizer, single- use<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">46<\/td>\n<td width=\"255\">Infant\/regional-body warmer<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">47<\/td>\n<td width=\"255\">Infant-hammock bed mattress<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">48<\/td>\n<td width=\"255\">Infant-hammock bed mattress overlay<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">49<\/td>\n<td width=\"255\">Internal defibrillator electrode, paediatric<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">50<\/td>\n<td width=\"255\">Lacrimal intubation set<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">51<\/td>\n<td width=\"255\">Liquid crystal vein locator<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">52<\/td>\n<td width=\"255\">Microlaryngeal probe<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">53<\/td>\n<td width=\"255\">Multifunction cardiac electrode, paediatric<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">54<\/td>\n<td width=\"255\">Neonatal chest percussor<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">55<\/td>\n<td width=\"255\">Neonatal CPAP unit<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">56<\/td>\n<td width=\"255\">Neonatal electrocardiographic electrode<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">57<\/td>\n<td width=\"255\">Neonatal hypothermia cot<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">58<\/td>\n<td width=\"255\">Neonatal hypothermia cot heat- conduction mattress<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">59<\/td>\n<td width=\"255\">Neonatal hypothermia cot heat- retention pad<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">60<\/td>\n<td width=\"255\">Neonatal intensive- care ventilator<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">61<\/td>\n<td width=\"255\">Neonatal kangaroo care garment<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">62<\/td>\n<td width=\"255\">Neonatal physiologic monitoring system<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">63<\/td>\n<td width=\"255\">Neonatal pulmonary surfactant catheter<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">64<\/td>\n<td width=\"255\">Neonatal\/paediatric heart rate monitoring application software<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">65<\/td>\n<td width=\"255\">Neonatal\/paediatric heart rate monitoring hardware<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">66<\/td>\n<td width=\"255\">Nitric oxide delivery unit, system-based<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">67<\/td>\n<td width=\"255\">Non-rechargeable public semi- automated external defibrillator electrode, paediatric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">68<\/td>\n<td width=\"255\">Open-ended adhesive infant\/paediatric urine collection bag<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">69<\/td>\n<td width=\"255\">Open-surgery manual linear cutting stapler, reprocessed<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">70<\/td>\n<td width=\"255\">Open-surgery manual linear cutting stapler, reusable<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">71<\/td>\n<td width=\"255\">Open-surgery manual linear cutting stapler, single-use<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">72<\/td>\n<td width=\"255\">Open-surgery manual linear stapler, reusable<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">73<\/td>\n<td width=\"255\">Open-surgery manual linear stapler, single- use<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">74<\/td>\n<td width=\"255\">Ophthalmic tonometer, battery- operated<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">75<\/td>\n<td width=\"255\">Orthopaedic medialization instrument<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">76<\/td>\n<td width=\"255\">Oxygen administration hood, paediatric<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">77<\/td>\n<td width=\"255\">Oxygen administration tent, neonatal\/paediatric<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">78<\/td>\n<td width=\"255\">Paediatric bed<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">79<\/td>\n<td width=\"255\">Paediatric blood donor set<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">80<\/td>\n<td width=\"255\">Paediatric cardiopulmonary bypass cannula<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">81<\/td>\n<td width=\"255\">Paediatric dental chair, electric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">82<\/td>\n<td width=\"255\">Paediatric dental chair, mechanical<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">83<\/td>\n<td width=\"255\">Paediatric dorsiflexion slant board<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">84<\/td>\n<td width=\"255\">Paediatric strabismus screening scanner<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">85<\/td>\n<td width=\"255\">Paediatric urine collection\/analysis kit<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">86<\/td>\n<td width=\"255\">Paediatric- temperature nasogastric\/orogastric tube<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">87<\/td>\n<td width=\"255\">Polyglyconate suture<\/td>\n<td width=\"83\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">88<\/td>\n<td width=\"255\">Blanket\/pad infant phototherapy unit<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">89<\/td>\n<td width=\"255\">Flotation therapy bed, neonatal<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">90<\/td>\n<td width=\"255\">Mobile steam washer\/disinfector<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">91<\/td>\n<td width=\"255\">Otoacoustic emission system, battery- powered<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">92<\/td>\n<td width=\"255\">Otoacoustic emission system, line-powered<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">93<\/td>\n<td width=\"255\">Overhead infant phototherapy unit<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">94<\/td>\n<td width=\"255\">Phototherapy eye protector, reusable<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">95<\/td>\n<td width=\"255\">Phototherapy eye protector, single-use<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">96<\/td>\n<td width=\"255\">Respiratory gas heating wire, infant<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">97<\/td>\n<td width=\"255\">Stationary pneumatic high-frequency ventilator respiration monitor<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">98<\/td>\n<td width=\"255\">Syringe pump<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">99<\/td>\n<td width=\"255\">Thoracic electrical impedance segmentography system<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">100<\/td>\n<td width=\"255\">Thoracic electrical impedance segmentography system electrode array<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">101<\/td>\n<td width=\"255\">Transcutaneous intracranial pressure sensor<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">102<\/td>\n<td width=\"255\">Wearable neonatal heart rate meter<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">103<\/td>\n<td width=\"255\">Antimicrobial infant garment<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">104<\/td>\n<td width=\"255\">Birthing bath<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">105<\/td>\n<td width=\"255\">Boiling water sterilizer<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">106<\/td>\n<td width=\"255\">Newborn-infant bed<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">107<\/td>\n<td width=\"255\">Resuscitator face mask, reusable<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">108<\/td>\n<td width=\"255\">Resuscitator face mask, single-use<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">109<\/td>\n<td width=\"255\">Warming infant bed, adjustable<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">110<\/td>\n<td width=\"255\">Warming infant bed, non-adjustable<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">111<\/td>\n<td width=\"255\">Bedrail pad<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">112<\/td>\n<td width=\"255\">Blanket\/pad infant phototherapy unit tester<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">113<\/td>\n<td width=\"255\">Blood transfusion set, exchange<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">114<\/td>\n<td width=\"255\">Blue light radiometer<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">115<\/td>\n<td width=\"255\">Cardiac septostomy catheter, balloon<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">116<\/td>\n<td width=\"255\">Cardiac septostomy catheter, blade<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">117<\/td>\n<td width=\"255\">Conventional infant incubator<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">118<\/td>\n<td width=\"255\">Cranial orthosis<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">119<\/td>\n<td width=\"255\">Home BPAP unit<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">120<\/td>\n<td width=\"255\">Multi-purpose saline solution<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">121<\/td>\n<td width=\"255\">Nappy changing table, portable<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">122<\/td>\n<td width=\"255\">Nasal aspirator, electric<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">123<\/td>\n<td width=\"255\">Open infant incubator<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">124<\/td>\n<td width=\"255\">Oral medicine dropper<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">125<\/td>\n<td width=\"255\">Oxygen breath analyser<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">126<\/td>\n<td width=\"255\">Oxygen terminal unit<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">127<\/td>\n<td width=\"255\">Pulmonary function analysis system, paediatric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">128<\/td>\n<td width=\"255\">Reactive-gel heating pad<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">129<\/td>\n<td width=\"255\">Respiratory apnoea monitoring system<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">130<\/td>\n<td width=\"255\">Rocking infant bed, electric<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">131<\/td>\n<td width=\"255\">Skin transilluminator, battery-powered<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">132<\/td>\n<td width=\"255\">Skin transilluminator, line-powered<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">133<\/td>\n<td width=\"255\">Teething device, fluid- filled<\/td>\n<td width=\"83\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">134<\/td>\n<td width=\"255\">Teething device, non- fluid-filled<\/td>\n<td width=\"83\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">135<\/td>\n<td width=\"255\">Transport infant incubator<\/td>\n<td width=\"83\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"57\">136<\/td>\n<td width=\"255\">Visual-reinforcement- audiometry reward system<\/td>\n<td width=\"83\">B<\/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=\"CDSCO_Classification_of_Paediatrics_and_Neonatology_Medical_Devices\"><\/span>CDSCO Classification of <span style=\"color: #2490eb;\">Paediatrics and Neonatology Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<thead>\n<tr>\n<td style=\"text-align: center;\"><strong><span style=\"color: #2490eb;\">Class<\/span><\/strong><\/td>\n<td style=\"text-align: center;\"><strong><span style=\"color: #2490eb;\">Risk Level<\/span><\/strong><\/td>\n<td style=\"text-align: center;\"><strong><span style=\"color: #2490eb;\">Examples of Devices<\/span><\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Class A<\/strong><\/td>\n<td>Low Risk<\/td>\n<td>Infant Care Table<\/td>\n<\/tr>\n<tr>\n<td><strong>Class B<\/strong><\/td>\n<td>Low-Moderate Risk<\/td>\n<td>Wearable neonatal heart rate meter, Rocking Infant bed electric, Teething device, fluid filled<\/td>\n<\/tr>\n<tr>\n<td><strong>Class C<\/strong><\/td>\n<td>Moderate-High Risk<\/td>\n<td>Neonatal CPAP Unit, Neonatal intensive-care ventilator<\/td>\n<\/tr>\n<tr>\n<td><strong>Class D<\/strong><\/td>\n<td>High Risk<\/td>\n<td>Craniofacial bone screw, bioabsorbable<\/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=\"When_Is_A_CDSCO_Paediatrics_Neonatology_License_Required\"><\/span>When Is A <span style=\"color: #2490eb;\">CDSCO Paediatrics &amp; Neonatology<\/span> License Required?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">If you fall into one of the following categories, you must register and gain approval for the license by CDSCO.<\/p>\n<ul style=\"text-align: justify;\">\n<li>Manufacturer of paediatric or neonatology devices in India<\/li>\n<li>Import paediatric or neonatology medical devices from overseas<\/li>\n<li>Distributor of medical devices<\/li>\n<li>An entity conducting R&amp;D activities<\/li>\n<li>Foreign enterprise holding an Indian subsidiary<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Import_License_for_Paediatrics_Neonatology_Medical_Devices\"><\/span><span style=\"color: #2490eb;\">Import License<\/span> for Paediatrics &amp; Neonatology Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The import license Form MD-15 is essential for foreign manufacturers to ensure that their devices follow India\u2019s safety, quality, and performance standards before they enter the Indian market. For this, you need to appoint an Indian Authorized Agent, or IAA, who will then obtain a Medical Device Registration Certificate (Form MD-42).<\/p>\n<p style=\"text-align: justify;\"><strong>The <span style=\"color: #2490eb;\">import license<\/span> process follows the steps given below:<\/strong><\/p>\n<ol style=\"text-align: justify;\">\n<li>Appoint an IAA who has a valid manufacturing or wholesale license (Form 20B, 21B) or Medical Device Registration Certificate (Form MD-42), as it authorizes them to import your paediatric or neonatology medical devices.<\/li>\n<li>Submit the Form MD-14 online at the Medical Device Sugam Portal. Fill the form with the needed documents, like the manufacturer\u2019s details, device classification, international certifications, Free Sale Certificate from the country of origin, Plant master file and Device master file.<\/li>\n<li>Once Form MD-15 or the import license for paediatric or neonatology medical device is issued, importers can proceed with customs clearance for their products.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Documentation_for_CDSCO_Paediatrics_Neonatology_Medical_Devices_License_for_Manufacturers_and_Importers\"><\/span>Documentation for <span style=\"color: #2490eb;\">CDSCO Paediatrics &amp; Neonatology<\/span> Medical Devices License for Manufacturers and Importers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Manufacturers and importers must abide by a list of comprehensive documentation. It applies to both the CDSCO Paediatrics Medical Devices license and the CDSCO Neonatology Medical Devices license, and covers the following:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Device Master File (DMF)<\/li>\n<li>Plant Master File (PMF)<\/li>\n<li>ISO 13485 certification<\/li>\n<li>CE\/FDA approvals (if applicable)<\/li>\n<li>Test License in Form MD-13 (for domestic manufacturers)<\/li>\n<li>Clinical evaluation reports (where required)<\/li>\n<li>Test reports from accredited labs<\/li>\n<li>Power of Attorney (for imports)<\/li>\n<li>Free Sale Certificate (for imports)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Steps_to_Obtain_License_for_CDSCO_Paediatrics_Neonatology_Medical_Devices_in_India\"><\/span>Steps to Obtain License for <span style=\"color: #2490eb;\">CDSCO Paediatrics &amp; Neonatology<\/span> Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">To gain the regulatory approval, you need to follow these steps. It starts with device classification, application submission, audit by the issuing authority officials, and finally the issuance of license.<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<thead>\n<tr>\n<td width=\"91\"><span style=\"color: #2490eb;\"><strong>Step<\/strong><\/span><\/td>\n<td width=\"536\"><span style=\"color: #2490eb;\"><strong>Description<\/strong><\/span><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"91\">Step 1<\/td>\n<td width=\"536\"><strong>Device Classification for Paediatrics &amp; Neonatology<\/strong> \u2013 The first step is to classify the paediatric or neonatology medical device according to CDSCO regulatory guidelines. Accurate classification determines the applicable regulatory pathway for devices like neonatal ventilators, paediatric thermometers, and other life-support equipment.<\/td>\n<\/tr>\n<tr>\n<td width=\"91\">Step 2<\/td>\n<td width=\"536\"><strong>Documentation Preparation<\/strong> \u2013 Prepare all necessary supporting documents for paediatric and neonatology devices, including technical details, safety data, clinical evaluation reports, and quality certifications relevant to the device.<\/td>\n<\/tr>\n<tr>\n<td width=\"91\">Step 3<\/td>\n<td width=\"536\"><strong>Application Form Completion<\/strong> \u2013 Fill out the applicable CDSCO registration form for Paediatrics Medical Devices license or Neonatology Medical Devices license with all required information, ensuring accuracy and completeness.<\/td>\n<\/tr>\n<tr>\n<td width=\"91\">Step 4<\/td>\n<td width=\"536\"><strong>Online Submission<\/strong> \u2013 Submit the completed application online through the CDSCO portal along with the necessary fees and documents, ensuring it is categorized under the correct device class.<\/td>\n<\/tr>\n<tr>\n<td width=\"91\">Step 5<\/td>\n<td width=\"536\"><strong>Review and Inspection<\/strong> \u2013 CDSCO officials will verify the submitted documents and review the application. For paediatric and neonatology devices, a facility inspection may be conducted, in case of domestic manufacturers to check whether it meets the compliance standards of manufacturing as per MDR-2017.<\/td>\n<\/tr>\n<tr>\n<td width=\"91\">Step 6<\/td>\n<td width=\"536\"><strong>Approval and Licensing<\/strong> \u2013 Upon successful evaluation, CDSCO will approve the paediatric or neonatology medical device and issue the required license. This authorises the legal sale and distribution of paediatric or neonatology devices in India.<\/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=\"License_and_Application_Fee_for_Medical_Devices\"><\/span>License and Application Fee for <span style=\"color: #2490eb;\">Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Depending on the classification of your medical device, the application process, fees, and processing time can be distinct. Below is a detailed overview of the CDSCO licensing requirements for each class of paediatrics and neonatology devices, as well as fees associated with your licence:<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<thead>\n<tr>\n<td style=\"text-align: center;\" width=\"106\"><span style=\"color: #2490eb;\"><strong>Device Class<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"198\"><span style=\"color: #2490eb;\"><strong>Government Fees<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"141\"><span style=\"color: #2490eb;\"><strong>Licensing Authority<\/strong><\/span><\/td>\n<td style=\"text-align: center;\" width=\"179\"><span style=\"color: #2490eb;\"><strong>Required Licenses<\/strong><\/span><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"106\"><strong>Manufacturing License for Paediatrics &amp; Neonatology Devices<\/strong><\/td>\n<td colspan=\"3\" width=\"518\"><\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class A<\/td>\n<td width=\"198\">Rs. 5,000 for one site and Rs. 500 for each medical device.<\/td>\n<td width=\"141\">State Licensing Authority (SLA)<\/td>\n<td rowspan=\"2\" width=\"179\">Form MD 5\/ Form MD 6<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class B<\/td>\n<td width=\"198\">Rs. 5,000 for one site and Rs. 500 for each medical device.<\/td>\n<td width=\"141\">State Licensing Authority (SLA)<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class C<\/td>\n<td width=\"198\">Rs. 50,000 for one site and Rs. 1,000 for each medical device.<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<td rowspan=\"2\" width=\"179\">Form MD 9\/ Form MD 10<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class D<\/td>\n<td width=\"198\">Rs. 50,000 for one site and Rs. 1,000 for each medical device.<\/p>\n<p>&nbsp;<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"106\"><strong>Import License for Paediatrics &amp; Neonatology Devices<\/strong><\/td>\n<td colspan=\"3\" width=\"518\"><\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class A<\/td>\n<td width=\"198\">USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device.<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<td rowspan=\"4\" width=\"179\">Form MD 15<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class B<\/td>\n<td width=\"198\">USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.<\/p>\n<p>&nbsp;<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class C<\/td>\n<td width=\"198\">USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.<\/p>\n<p>&nbsp;<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<tr>\n<td width=\"106\">Class D<\/td>\n<td width=\"198\">USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.<\/p>\n<p>&nbsp;<\/td>\n<td width=\"141\">CDSCO (Central Licensing Authority)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Note_that_this_license_is_valid_for_5_years_and_is_renewable_with_a_retention_fee_before_expiry\"><\/span>*Note that this license is valid for 5 years and is renewable with a retention fee before expiry.<span class=\"ez-toc-section-end\"><\/span><\/h3>\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;\">As a leader in CDSCO regulatory service provider, matching the industry requirements, <a href=\"https:\/\/www.dueranconsultancy.com\/\">Dueran Consultant<\/a> helps you identify the applicable guidelines, the class of your device, and the documentation. We also notify you of any changes to the process and respond promptly to CDSCO queries. You can trust us to handle the complexities of this process.<\/p>\n<p style=\"text-align: justify;\">We\u2019ll make sure that everything runs smoothly while you provide the necessary information as needed. Reach us through phone, call, or email, and we\u2019ll quickly schedule a no-obligation consultation.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span style=\"color: #2490eb;\">:<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The licensing process for CDSCO paediatrics &amp; neonatology medical devices is rigorous, but imperative for patient safety and product quality. No matter the license you apply for, it can be a CDSCO Paediatrics Medical Devices license or a CDSCO Neonatology Medical Devices license, you must be aware of your device\u2019s classification, key documentation, and approval steps, as mentioned above.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>India has a growing demand for paediatric and neonatology medical devices, which has made regulatory compliance a top priority for<\/p>\n","protected":false},"author":1,"featured_media":8481,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[692,687,690,688,691,689],"class_list":["post-8479","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-neonatology-medical-devices-license","tag-cdsco-pediatrics-neonatology-medical-devices","tag-cdsco-pediatrics-and-neonatology-license-in-india","tag-cdsco-pediatrics-and-neonatology-medical-devices-license","tag-cdsco-pediatrics-medical-devices-license","tag-import-license-for-pediatrics-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CDSCO Paediatrics &amp; 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