{"id":8472,"date":"2026-01-18T17:47:52","date_gmt":"2026-01-18T17:47:52","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8472"},"modified":"2026-01-18T17:52:41","modified_gmt":"2026-01-18T17:52:41","slug":"cdsco-neurological-medical-devices","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-neurological-medical-devices\/","title":{"rendered":"CDSCO Neurological Medical Devices Registration in India"},"content":{"rendered":"<p style=\"text-align: justify;\">Medical devices that help diagnose and treat neurological conditions (issues related to the brain and nervous system) are advancing rapidly in India. But before they are used to save the lives of patients, <a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\">CDSCO<\/a> ensures that they meet rigorous safety standards. If you manufacture or import neurological medical devices in India, you must note the updated requirements. It will facilitate you in getting the manufacturing (MD-5, MD-6, MD-9 and MD-10) or import (MD-15) license quickly. Keep reading as we explain all that you should do to produce and sell neurological medical devices in India.<\/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-neurological-medical-devices\/#What_CDSCO_Says_About_Neurological_Medical_Devices\" >What CDSCO Says About Neurological 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-neurological-medical-devices\/#CDSCO_Medical_Device_Classification_for_Neurology\" >CDSCO Medical Device Classification for Neurology<\/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-neurological-medical-devices\/#Which_License_Do_You_Need_to_Manufacture_Your_Neurological_Device_in_India\" >Which License Do You Need to Manufacture Your Neurological Device in India?<\/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-neurological-medical-devices\/#Which_License_Do_You_Need_to_Import_Your_Neurological_Device_in_India\" >Which License Do You Need to Import Your Neurological Device 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-neurological-medical-devices\/#Checklist_for_the_Manufacturing_License_of_Neurological_Devices\" >Checklist for the Manufacturing License of Neurological 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-neurological-medical-devices\/#How_to_Get_the_Form_MD-15_License_to_Import_Neurological_Devices_in_India\" >How to Get the Form MD-15 License to Import Neurological Devices in India?<\/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-neurological-medical-devices\/#Concluding_Words\" >Concluding Words:<\/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-neurological-medical-devices\/#Frequently_Asked_Questions_FAQs\" >Frequently Asked Questions (FAQ&#8217;s)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-neurological-medical-devices\/#1_Can_a_Foreign_Manufacturer_Apply_for_MD-15_Directly\" >1. Can a Foreign Manufacturer Apply for MD-15 Directly?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-neurological-medical-devices\/#Import_License_for_your_Neurological_Device\" >Import License for your Neurological Device:<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_CDSCO_Says_About_Neurological_Medical_Devices\"><\/span>What CDSCO Says About <span style=\"color: #2490eb;\">Neurological<\/span> Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The CDSCO, or Central Drugs Standard Control Organisation, is India&#8217;s primary medical device regulator under the Ministry of Health and Family Welfare. It operates through the Drug Controller General of India (DCGI), who leads all regulatory operations.<\/p>\n<p style=\"text-align: justify;\">Few years back, CDSCO published its foundational neurological device classification list. CDSCO medical device classification for Neurology ensures that all devices meet regulatory standards. Based on the risk class of every device, it needs to undergo a specific licensing process.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CDSCO_Medical_Device_Classification_for_Neurology\"><\/span>CDSCO <span style=\"color: #2490eb;\">Medical Device<\/span> Classification for Neurology<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">CDSCO license for neurological medical devices operates on a risk-based classification framework, dividing devices into 4 risk categories. These are:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Low-risk Class A devices<\/li>\n<li>Low to moderate risk Class B devices<\/li>\n<li>Moderate high-risk Class C devices<\/li>\n<li>High-risk Class D devices<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The class-wise list of medical devices is published by the CDSCO which shows the regulatory requirements and allows manufacturers to plan the product development, testing, and approval processes of their neurological devices. You can also refer to the table below to check which class your device belongs to. From deep-brain stimulation systems, neurostimulators, to Electroencephalographic monitoring systems, and more, everything is classified here.<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<tbody>\n<tr>\n<td width=\"63\">\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=\"339\"><span style=\"color: #2490eb;\"><strong>Device Name<\/strong><\/span><\/td>\n<td width=\"88\">\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=\"63\">1<\/td>\n<td width=\"339\">Analgesic PENS system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">2<\/td>\n<td width=\"339\">Analgesic TENS system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">3<\/td>\n<td width=\"339\">Analytical non- scalp cutaneous electrode<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">4<\/td>\n<td width=\"339\">Analytical non- scalp cutaneous lead<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">5<\/td>\n<td width=\"339\">Analytical scalp electrode<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">6<\/td>\n<td width=\"339\">Analytical scalp lead<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">7<\/td>\n<td width=\"339\">Aneurysm clip<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">8<\/td>\n<td width=\"339\">Antiseizure\/psychiatric-therapy vagus nerve electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">9<\/td>\n<td width=\"339\">Atrial cerebrospinal fluid catheter<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">10<\/td>\n<td width=\"339\">Autonomic neuropathy heart rate meter<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">11<\/td>\n<td width=\"339\">Bare-metal intracranial vascular stent<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">12<\/td>\n<td width=\"339\">Behavioural therapy electrical stimulation system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">13<\/td>\n<td width=\"339\">Bladder\/bowel- evacuation implantable electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">14<\/td>\n<td width=\"339\">Brain injury adjunctive interpretive electroencephalograph assessment aid.<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">15<\/td>\n<td width=\"339\">Brain-responsive electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">16<\/td>\n<td width=\"339\">Cardiac-therapy vagus nerve electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">17<\/td>\n<td width=\"339\">Cerebral perfusion catheter<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">18<\/td>\n<td width=\"339\">Cerebrospinal fluid manometer,<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">19<\/td>\n<td width=\"339\">Cerebrospinal fluid shunt valve programmer<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">20<\/td>\n<td width=\"339\">Coma-arousal vagus nerve electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">21<\/td>\n<td width=\"339\">Cortical electrode<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">22<\/td>\n<td width=\"339\">Cranial bur<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">23<\/td>\n<td width=\"339\">Cranial electrotherapy stimulator<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">24<\/td>\n<td width=\"339\">Cranial perforator<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">25<\/td>\n<td width=\"339\">Cranial trephine<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">26<\/td>\n<td width=\"339\">Craniotomy power tool system handpiece<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">27<\/td>\n<td width=\"339\">Cryogenic surgical device.<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">28<\/td>\n<td width=\"339\">Cutaneous electrode.<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">29<\/td>\n<td width=\"339\">Deep-brain electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">30<\/td>\n<td width=\"339\">Deep-brain electrical stimulation system lead<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">31<\/td>\n<td width=\"339\">Depth electrode<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">32<\/td>\n<td width=\"339\">Diagnostic peripheral nerve electrical stimulation system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">33<\/td>\n<td width=\"339\">Diagnostic somatosensory tactile stimulation system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">34<\/td>\n<td width=\"339\">Diskectomy system, percutaneous, automatic<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">35<\/td>\n<td width=\"339\">Dura mater sealant<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">36<\/td>\n<td width=\"339\">Echoencephalograph<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">37<\/td>\n<td width=\"339\">Ejaculation electrical stimulation system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">38<\/td>\n<td width=\"339\">Electroconvulsive therapy system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">39<\/td>\n<td width=\"339\">Electroencephalogram (EEG) signal spectrum analyser<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">40<\/td>\n<td width=\"339\">Electroencephalograph electrode\/lead tester<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">41<\/td>\n<td width=\"339\">Electroencephalograph test signal generator<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">42<\/td>\n<td width=\"339\">Electroencephalograph tester<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">43<\/td>\n<td width=\"339\">Electroencephalograph<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">44<\/td>\n<td width=\"339\">Electroencephalographic electrode cap<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">45<\/td>\n<td width=\"339\">Electroencephalographic long-term ambulatory recorder<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">46<\/td>\n<td width=\"339\">Electroencephalographic monitoring system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">47<\/td>\n<td width=\"339\">Electromyograph<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">48<\/td>\n<td width=\"339\">Electronystagmograph<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">49<\/td>\n<td width=\"339\">Epicranial brain electrical stimulation system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">50<\/td>\n<td width=\"339\">Esthesiometer<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">51<\/td>\n<td width=\"339\">Extramuscular diaphragm\/phrenic nerve electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">52<\/td>\n<td width=\"339\">Facial nerve locating system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">53<\/td>\n<td width=\"339\">Gait- enhancement electrical stimulation system, external<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">54<\/td>\n<td width=\"339\">Gait-enhancement electrical stimulation system, implantable<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">55<\/td>\n<td width=\"339\">Home seizure monitoring system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">56<\/td>\n<td width=\"339\">Human dura mater<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">57<\/td>\n<td width=\"339\">Implantable pulse generator mesh bag, bioabsorbable<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">58<\/td>\n<td width=\"339\">Implantable spinal cord electrical stimulation system programmer<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">59<\/td>\n<td width=\"339\">Implanted cerebellar stimulator<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">60<\/td>\n<td width=\"339\">Implanted diaphragmatic\/phrenic nerve stimulator<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">61<\/td>\n<td width=\"339\">Implanted intracerebral\/subcortical stimulator for pain relief<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">62<\/td>\n<td width=\"339\">Implanted neuromuscular stimulator<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">63<\/td>\n<td width=\"339\">Implanted spinal cord stimulator for bladder evacuation<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">64<\/td>\n<td width=\"339\">Intracranial pressure monitor device<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">65<\/td>\n<td width=\"339\">Intramuscular diaphragm\/phrenic nerve electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">66<\/td>\n<td width=\"339\">Intramuscular diaphragm\/phrenic nerve electrical stimulation system programmer<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">67<\/td>\n<td width=\"339\">Intranasal cooling system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">68<\/td>\n<td width=\"339\">Invasive- detection physiological monitor<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">69<\/td>\n<td width=\"339\">Leukotome<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">70<\/td>\n<td width=\"339\">Magnetoencephalography system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">71<\/td>\n<td width=\"339\">Manual surgical saw, flexible<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">72<\/td>\n<td width=\"339\">Meningeal prosthesis<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">73<\/td>\n<td width=\"339\">Nasopharyngeal electrode<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">74<\/td>\n<td width=\"339\">Needle electrode<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">75<\/td>\n<td width=\"339\">Nerve conduction velocity measurement device<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">76<\/td>\n<td width=\"339\">Nerve guide, bioabsorbable, animal-derived<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">77<\/td>\n<td width=\"339\">Nerve guide, bioabsorbable, synthetic<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">78<\/td>\n<td width=\"339\">Nerve guide, non- bioabsorbable<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">79<\/td>\n<td width=\"339\">Neurological endoscope<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">80<\/td>\n<td width=\"339\">Neurological stereotactic surgery system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">81<\/td>\n<td width=\"339\">Neuromuscular transmission electrical skin sensor<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">82<\/td>\n<td width=\"339\">Neuromuscular transmission motion sensor<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">83<\/td>\n<td width=\"339\">Neuropsychiatric interpretive electroencephalograph assessment aid<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">84<\/td>\n<td width=\"339\">Neurosurgical chair<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">85<\/td>\n<td width=\"339\">Neurosurgical head holder (skull clamp)<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">86<\/td>\n<td width=\"339\">Neurosurgical headrests<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">87<\/td>\n<td width=\"339\">Neurosurgical microscope<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">88<\/td>\n<td width=\"339\">Neurosurgical ultrasound navigation<br \/>\nsystem<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">89<\/td>\n<td width=\"339\">Non- electroencephalogram (EEG) physiological signal-based seizure monitoring system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">90<\/td>\n<td width=\"339\">Nonpowered neurosurgical instrument<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">91<\/td>\n<td width=\"339\">Olfactometry system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">92<\/td>\n<td width=\"339\">Percussion hammer, manual<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">93<\/td>\n<td width=\"339\">Percussor<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">94<\/td>\n<td width=\"339\">Photodiode subretinal prosthesis system<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">95<\/td>\n<td width=\"339\">Physical therapy ultrasound\/neuromuscular stimulation system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">96<\/td>\n<td width=\"339\">Pinwheel<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">97<\/td>\n<td width=\"339\">Rheoencephalograph<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">98<\/td>\n<td width=\"339\">Scalp clip<\/td>\n<td width=\"88\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">99<\/td>\n<td width=\"339\">Scoliosis- treatment electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">100<\/td>\n<td width=\"339\">Skull plate anvil<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">101<\/td>\n<td width=\"339\">Skull punch<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">102<\/td>\n<td width=\"339\">Skullplate screwdriver<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">103<\/td>\n<td width=\"339\">Stereotactic neuronavigation\/ planning system<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">104<\/td>\n<td width=\"339\">Stereotactic radiosurgical system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">105<\/td>\n<td width=\"339\">Tibial nerve percutaneous incontinence- control electrical stimulation system<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">106<\/td>\n<td width=\"339\">Transcranial electrical stimulation system, continuous- current and pulsed-current<\/td>\n<td width=\"88\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">107<\/td>\n<td width=\"339\">Transvenous phrenic nerve electrical stimulation control unit<\/td>\n<td width=\"88\">D<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">108<\/td>\n<td width=\"339\">Tuning fork<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">109<\/td>\n<td width=\"339\">Ultrasonic scanner calibration test block<\/td>\n<td width=\"88\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"63\">110<\/td>\n<td width=\"339\">Vagus nerve electrical stimulation system programmer<\/td>\n<td width=\"88\">C<\/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=\"Which_License_Do_You_Need_to_Manufacture_Your_Neurological_Device_in_India\"><\/span>Which License Do You Need to Manufacture Your <span style=\"color: #2490eb;\">Neurological Device<\/span> in India?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Once you know the risk-based classification of your neurological device, you can apply for one or both of the following licenses.<\/p>\n<ol style=\"text-align: justify;\">\n<li>Class A and B devices with low to moderate risk require the MD-5\/ MD-6 manufacturing license which will be issued by the State Licensing Authority (SLA).<\/li>\n<li>Class C and D devices with moderate to high risk require the MD-9\/ MD-10 manufacturing license, which will be issued by the Central Licensing Authority (CDSCO).<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Which_License_Do_You_Need_to_Import_Your_Neurological_Device_in_India\"><\/span>Which License Do You Need to <span style=\"color: #2490eb;\">Import Your Neurological Device in India<\/span>?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The MD-15 is the import license for neurological devices. To apply for it, importers must fill out the MD-14 application form. The entire process is overseen by CDSCO and, if done properly, gets approval in a stipulated time.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Checklist_for_the_Manufacturing_License_of_Neurological_Devices\"><\/span>Checklist for the Manufacturing License of <span style=\"color: #2490eb;\">Neurological Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Your application to manufacture Neurological Medical devices needs the following documents:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Device master file with extensive Device Details<\/li>\n<li>Plant\/Site Master File (PMF\/SMF) describing the manufacturing facility, layout, processes, and controls<\/li>\n<li>Quality management procedures<\/li>\n<li>ISO 13485 certification or equivalent quality management documentation<\/li>\n<li>Product test reports from approved laboratories<\/li>\n<li>Post-market surveillance and adverse event reporting plan<\/li>\n<li>Proof of facility ownership or lease<\/li>\n<li>Building layout with room dimensions<\/li>\n<li>Technical staff qualifications<\/li>\n<li>Government Fees as per the Medical Devices Rules 2017<\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li>Safety\/clinical safety summary, where applicable<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_to_Get_the_Form_MD-15_License_to_Import_Neurological_Devices_in_India\"><\/span>How to Get the Form MD-15 License to <span style=\"color: #2490eb;\">Import Neurological Devices in India<\/span>?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">CDSCO issues Form MD-15 license for all imported medical Neurological devices. Regardless of your product\u2019s risk class, you must follow the regulatory process for MD-15 in order to gain approval. If the following documents are accurate and are submitted on time, you receive the license in stipulated time.<\/p>\n<ul style=\"text-align: justify;\">\n<li>Application in Form MD-14<\/li>\n<li>Regulatory approvals from the country of origin<\/li>\n<li>Free Sale Certificate proving the device is freely sold in the country of origin<\/li>\n<li>Free Sale Certificate from any of the following countries like United States of America (USA), the United Kingdom (UK), the European Union, Canada, Australia or Japan.<\/li>\n<li>Device master file with complete technical specifications<\/li>\n<li>Plant Master File as per the Medical Devices Rules 2017<\/li>\n<li>Quality management system certification (ISO 13485 or equivalent)<\/li>\n<li>Risk management documentation<\/li>\n<li>Post-market surveillance Data<\/li>\n<li>Audit Report<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Concluding_Words\"><\/span>Concluding Words<span style=\"color: #2490eb;\">:<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">That&#8217;s all you need to know to manufacture or import neurological devices in India. Do not consider the CDSCO medical device classification for Neurology merely a regulatory obligation. It is your commitment to Indian neurological patients. At the same time, growing neurological disease burden and healthcare investment have created genuine opportunities for quality neurological devices. Professional regulatory guidance accelerates your market entry and establishes a foundation for sustained business growth.<\/p>\n<p style=\"text-align: justify;\">If you are trying to get a license for the first time or simply don&#8217;t have enough time to understand the changing regulatory needs, feel free to seek our support. <a href=\"https:\/\/www.dueranconsultancy.com\/\">Dueran Consultant<\/a> experienced team stands ready to guide you toward successful CDSCO approval and sustained market leadership. We have been helping importers and manufacturers simplify medical device licensing complexities so they can bring their products to market faster while being compliant. You can seek our customised assistance anytime and be assured of 100% approval from the Indian regulatory authorities.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions_FAQs\"><\/span>Frequently Asked Questions <span style=\"color: #2490eb;\">(FAQ&#8217;s)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"1_Can_a_Foreign_Manufacturer_Apply_for_MD-15_Directly\"><\/span><span style=\"color: #2490eb;\">1.<\/span> Can a Foreign Manufacturer Apply for MD-15 Directly?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Answer: No. A foreign manufacturer cannot apply for an MD-15 import license directly in India. Under the Medical Device Rules 2017, the MD-15 license is always issued to an Indian entity, an authorised Indian agent, distributor, or importer who holds a valid wholesale\/distribution license (Form 20B\/21B or MD\u201142 for medical devices). They must be a registered legal entity in India with an active CIN and an Indian resident signatory.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Import_License_for_your_Neurological_Device\"><\/span>Import License for your Neurological Device:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Here are the steps to appoint an Indian authorised agent to get an import license for your neurological device.<\/p>\n<ul style=\"text-align: justify;\">\n<li>Identify the agent. Shortlist importers, distributors, or regulatory firms that already hold 20B\/21B or MD\u201142 license.<\/li>\n<li>Issue a Power of Attorney (POA) that authorises the Indian agent to act on the manufacturer\u2019s behalf for all CDSCO matters for obtaining the MD\u201115 license.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">In a separate agreement, clearly assign obligations to the agent for post\u2011market surveillance and SAE reporting, labelling, vigilance communication, and license renewals and change notifications.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical devices that help diagnose and treat neurological conditions (issues related to the brain and nervous system) are advancing rapidly<\/p>\n","protected":false},"author":1,"featured_media":8475,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[684,685,682,686,683],"class_list":["post-8472","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-license-for-neurological-medical-devices","tag-cdsco-medical-device-classification-for-neurology","tag-cdsco-neurological-medical-devices","tag-medical-device-license-for-neurological-devices","tag-neurological-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CDSCO Neurological Medical Devices Registration in India<\/title>\n<meta name=\"description\" content=\"Get the updated CDSCO neurological medical devices risk-based classification and licensing process for importers and manufacturers.\" 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