{"id":8449,"date":"2025-12-10T19:59:44","date_gmt":"2025-12-10T19:59:44","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=8449"},"modified":"2025-12-10T20:01:03","modified_gmt":"2025-12-10T20:01:03","slug":"cdsco-operation-theatre-medical-devices-licensing","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-operation-theatre-medical-devices-licensing\/","title":{"rendered":"CDSCO Operation Theatre Medical Devices Licensing"},"content":{"rendered":"<p>If you work with Operation Theatre (OT) equipment in India\u2014buying, importing, manufacturing, or selling- you live under the Medical Devices Rules, 2017 (MDR 2017) and the watchful eye of CDSCO. This post breaks down the CDSCO classification of medical devices in the operating theatre, how the <a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" target=\"_blank\" rel=\"nofollow noopener\">CDSCO<\/a> Operation Theatre Medical Equipment license actually works, and the paperwork you\u2019ll really be asked for.<\/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-operation-theatre-medical-devices-licensing\/#What_Counts_as_an_Operation_Theatre_Device_for_CDSCO\" >What Counts as an Operation Theatre Device for CDSCO<\/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-operation-theatre-medical-devices-licensing\/#A_Word_of_Caution\" >A Word of Caution<\/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-operation-theatre-medical-devices-licensing\/#Do_You_Need_a_Special_CDSCO_Operation_Theatre_Medical_Devices_License\" >Do You Need a Special CDSCO Operation Theatre Medical Devices License?<\/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-operation-theatre-medical-devices-licensing\/#Some_Examples_of_Risk_Classes_of_CDSCO_Operation_Theatre_Medical_Devices\" >Some Examples of Risk Classes of CDSCO Operation Theatre Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/cdsco-operation-theatre-medical-devices-licensing\/#Official_Classification_of_OT_Medical_Devices_According_to_CDSCO\" >Official Classification of OT Medical Devices According to CDSCO<\/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-operation-theatre-medical-devices-licensing\/#How_to_Get_an_Import_License_for_Operation_Theatre_Medical_Devices_MD-15_via_MD-14\" >How to Get an Import License for Operation Theatre Medical Devices (MD-15 via MD-14)<\/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-operation-theatre-medical-devices-licensing\/#How_to_Get_a_Manufacturing_License_for_OT_Devices\" >How to Get a Manufacturing License for OT Devices?<\/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-operation-theatre-medical-devices-licensing\/#Post-Market_Surveillance_PMS_Materiovigilance_%E2%80%93_Why_Is_It_an_Ongoing_Responsibility\" >Post-Market Surveillance (PMS) &amp; Materiovigilance &#8211; Why Is It an Ongoing Responsibility<\/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-operation-theatre-medical-devices-licensing\/#Common_Pitfalls_While_Applying_for_the_License\" >Common Pitfalls While Applying for the License<\/a><\/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-operation-theatre-medical-devices-licensing\/#How_Dueran_Consultant_Helps_You\" >How Dueran Consultant Helps You<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_Counts_as_an_Operation_Theatre_Device_for_CDSCO\"><\/span>What Counts as an Operation Theatre Device for <span style=\"color: #2490eb;\">CDSCO<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CDSCO issues category-wise, risk-based classifications. One of those categories is the Operating Theatre (OT). In September 2021, CDSCO published a list of OT-specific devices with risk classes A, B, C or D (A = lowest risk; D = highest overall).<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"A_Word_of_Caution\"><\/span>A Word of Caution<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Many importers and manufacturers miss a practical yet subtle nuance. Devices commonly found in an OT, like anaesthesia workstations, ventilators, defibrillators, imaging gear, may be classified under other CDSCO categories (e.g., Anesthesiology, Respiratory, General Hospital, Interventional Radiology). This happens even though they physically sit in the OT. So when you\u2019re mapping your portfolio, don\u2019t stop at the \u201cOT\u201d list; check the other category lists too.<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Do_You_Need_a_Special_CDSCO_Operation_Theatre_Medical_Devices_License\"><\/span>Do You Need a Special CDSCO Operation Theatre Medical Devices License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Not exactly. In India, the license depends on what you do with the device. If you&#8217;re an importer, you apply in Form MD-14 and, if approved, you receive Form MD-15. This is your CDSCO import license for Operation Theatre Medical Devices. There\u2019s an official CDSCO MD-15 checklist (and a specimen MD-14 form) you\u2019ll be measured against.<\/p>\n<p>If you manufacture medical devices used in OT, apply in following forms based on the device&#8217;s class:<\/p>\n<ol>\n<li><strong>Class A &amp; B:<\/strong> Apply Form MD-3 &amp; Form MD-4. License is Form MD-5 &amp; Form MD-6 (issued by State Licensing Authority).<\/li>\n<li><strong>Class C &amp; D:<\/strong> Apply Form MD-7 &amp; Form MD-8. License is Form MD-9 &amp; Form MD-10 (issued by Central Licensing Authority).<\/li>\n<li><strong>Sell\/stock\/distribute (wholesale\/retail):<\/strong> You need Form MD-42. It is the registration certificate to sell, stock, exhibit or offer for sale or distribute medical devices. If you plan to import and sell, Form MD-42 is the pre-requisite license.<\/li>\n<\/ol>\n<p>So when you hear \u201cCDSCO Operation Theatre Medical Equipment license\u201d or \u201cCDSCO Operation Theatre Medical Devices license,\u201d it&#8217;s about MD-15 (import) or MD-5 &amp; MD-6, MD-9 &amp; MD-10 (manufacture) and, often, MD-42 (sale\/distribution) layered on top.<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Some_Examples_of_Risk_Classes_of_CDSCO_Operation_Theatre_Medical_Devices\"><\/span>Some Examples of Risk Classes of <span style=\"color: #2490eb;\">CDSCO Operation Theatre Medical Devices<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CDSCO\u2019s OT list maps every device and its intended use. It then assigns it a risk class. A few examples that your regulatory file may include are:<\/p>\n<ul>\n<li>Retractors\/distractors \u2013 Class A<\/li>\n<li>Suction systems (portable, electrical\/pneumatic, or vacuum line) \u2013 Class A<\/li>\n<li>Operation table systems (powered and manual variants) \u2013 Class A<\/li>\n<li>Surgical light system \u2013 Class A<\/li>\n<li>Sterile hemostatic clip applier \u2013 Class B (Non-sterile is Class A)<\/li>\n<li>Scalpel blade \u2013 Class B<\/li>\n<li>General-purpose electrosurgical unit \u2013 Class C<\/li>\n<li>Warming high-flow infusion pump \/ high-flow blood transfusion pump \u2013 Class C<\/li>\n<li>Multiparameter monitor with critical parameters \u2013 Class C<\/li>\n<\/ul>\n<p>When in doubt, look at the official OT list. If your device is absent, check the other CDSCO Medical Device Classification list.<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Official_Classification_of_OT_Medical_Devices_According_to_CDSCO\"><\/span>Official Classification of OT <span style=\"color: #2490eb;\">Medical Devices<\/span> According to CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Refer to this table to find out the risk class of your device.<\/p>\n<table width=\"400\">\n<tbody>\n<tr>\n<td width=\"64\">\n<p style=\"text-align: center;\"><span style=\"color: #0000ff;\"><strong>S. No.<\/strong><\/span><\/p>\n<\/td>\n<td style=\"text-align: center;\" width=\"269\"><span style=\"color: #0000ff;\"><strong>Device name<\/strong><\/span><\/td>\n<td width=\"67\">\n<p style=\"text-align: center;\"><span style=\"color: #0000ff;\"><strong>Risk Class<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>1<\/strong><\/td>\n<td width=\"269\">Distractor \/ Retractors<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>2<\/strong><\/td>\n<td width=\"269\">Suction system portable, Electrical \/ Pneumatic<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>3<\/strong><\/td>\n<td width=\"269\">Suction system operated by vacuum<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>4<\/strong><\/td>\n<td width=\"269\">Operation table system<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>5<\/strong><\/td>\n<td width=\"269\">General-purpose diagnosis\/treatment table<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>6<\/strong><\/td>\n<td width=\"269\">Surgical light system<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>7<\/strong><\/td>\n<td width=\"269\">Non-sterile Hemostatic clip applier<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>8<\/strong><\/td>\n<td width=\"269\">Sterile Hemostatic clip applier<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>9<\/strong><\/td>\n<td width=\"269\">Hemostatic knife<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>10<\/strong><\/td>\n<td width=\"269\">Non-sterile Scalpel<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>11<\/strong><\/td>\n<td width=\"269\">Sterile Scalpel<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>12<\/strong><\/td>\n<td width=\"269\">Scalpel blade<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>13<\/strong><\/td>\n<td width=\"269\">Non-sterile Surgical forceps<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>14<\/strong><\/td>\n<td width=\"269\">Sterile Surgical forceps<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>15<\/strong><\/td>\n<td width=\"269\">General-purpose electrosurgical unit<\/td>\n<td width=\"67\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>16<\/strong><\/td>\n<td width=\"269\">Long-term use enterostomy feeding tube<\/td>\n<td width=\"67\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>17<\/strong><\/td>\n<td width=\"269\">Warming high-flow infusion pump<\/td>\n<td width=\"67\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>18<\/strong><\/td>\n<td width=\"269\">High-flow blood transfusion pump<\/td>\n<td width=\"67\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>19<\/strong><\/td>\n<td width=\"269\">Non-sterile Staple remover<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>20<\/strong><\/td>\n<td width=\"269\">Sterile Staple remover<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>21<\/strong><\/td>\n<td width=\"269\">Non-sterile Surgical punch<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>22<\/strong><\/td>\n<td width=\"269\">Sterile Surgical punch<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>23<\/strong><\/td>\n<td width=\"269\">Non-sterile Surgical file<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>24<\/strong><\/td>\n<td width=\"269\">Sterile Surgical file<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>25<\/strong><\/td>\n<td width=\"269\">Non-sterile Blood vessel surgical stripper<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>26<\/strong><\/td>\n<td width=\"269\">Sterile Blood vessel surgical stripper<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>27<\/strong><\/td>\n<td width=\"269\">Non-sterile Surgical probe<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>28<\/strong><\/td>\n<td width=\"269\">Sterile Surgical probe<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>29<\/strong><\/td>\n<td width=\"269\">Multiparameter monitor with critical parameters<\/td>\n<td width=\"67\">C<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>30<\/strong><\/td>\n<td width=\"269\">Surgical robot unit<\/td>\n<td width=\"67\">B<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>31<\/strong><\/td>\n<td width=\"269\">Motorized diagnostic imaging view box<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>32<\/strong><\/td>\n<td width=\"269\">General-purpose manually-operated operation table<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>33<\/strong><\/td>\n<td width=\"269\">Powered general- purpose operation table<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<tr>\n<td width=\"64\"><strong>34<\/strong><\/td>\n<td width=\"269\">Operation table system<\/td>\n<td width=\"67\">A<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_Get_an_Import_License_for_Operation_Theatre_Medical_Devices_MD-15_via_MD-14\"><\/span>How to Get an <span style=\"color: #2490eb;\">Import License for Operation Theatre<\/span> Medical Devices (MD-15 via MD-14)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>This is the path to follow if you\u2019re bringing devices into the Indian market:<\/strong><\/p>\n<p><strong>1. Application:<\/strong> File MD-14 on the CDSCO portal. Your license, if granted, comes as MD-15.<\/p>\n<p><strong>2. Core documents:<\/strong> The official CDSCO checklist for MD-15 is your north star. The essentials include device details, Free Sale Certificate, regulatory approvals in other markets (if any), labelling\/IFU, QMS evidence, clinical\/performance data where relevant, PMS\/vigilance approach, and batch\/CoA or software version evidence as applicable.<\/p>\n<p><strong>3. Local presence:<\/strong> Traditionally, Foreign manufacturers appoint an authorized Indian agent. In practice, if you are the Indian entity of record, you\u2019ll still need the sale\/distribution registration (MD-42) to legally stock and sell.<\/p>\n<p><strong>4. If no predicate device exists in India:<\/strong> Get permission in MD-27 (the \u201cno predicate\u201d pathway) before a full marketing license.<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_Get_a_Manufacturing_License_for_OT_Devices\"><\/span>How to Get a Manufacturing License for OT Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If you build medical devices in India, here are the license types and expectations from you:<\/p>\n<div class=\"container table-responsive py-5\">\n<table class=\"table table-bordered table-hover\">\n<tbody>\n<tr>\n<td><span style=\"color: #0000ff;\"><strong>Steps<\/strong><\/span><\/td>\n<td><span style=\"color: #0000ff;\"><strong>Applies To<\/strong><\/span><\/td>\n<td><span style=\"color: #0000ff;\"><strong>Forms (Application \u2192 License)<\/strong><\/span><\/td>\n<td><span style=\"color: #0000ff;\"><strong>Licensing Authority<\/strong><\/span><\/td>\n<td><span style=\"color: #0000ff;\"><strong>What reviewers expect (key artifacts)<\/strong><\/span><\/td>\n<td><span style=\"color: #0000ff;\"><strong>Practical notes<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td><strong>Manufacturing license<\/strong><\/td>\n<td><strong>Class A &amp; B OT devices (e.g., surgical lights, OT tables, non-sterile instruments)<\/strong><\/td>\n<td><strong>MD-3 \u2192 MD-5<\/strong><\/td>\n<td><strong>State Licensing Authority (SLA)<\/strong><\/td>\n<td>\u2022 Device description &amp; intended use (mapped to OT classification)<\/p>\n<p>\u2022 Risk class rationale<\/p>\n<p>\u2022 Essential Principles checklist (MDR 2017)<\/p>\n<p>\u2022 ISO 13485 certificate (valid &amp; scope-matched)<\/p>\n<p>\u2022 Site Master File, plant layout<\/p>\n<p>\u2022 Process validations (sterilization, packaging, cleaning where relevant)<\/p>\n<p>\u2022 Test reports to applicable BIS\/IEC\/ISO standards<\/p>\n<p>\u2022 Labeling\/IFU<\/p>\n<p>\u2022 PMS plan (complaints, vigilance\/MvPI flow)<\/p>\n<p>\u2022 QA\/QC SOPs, calibration &amp; equipment logs, training records<\/td>\n<td>\u2022 Expect a site inspection by SLA<\/p>\n<p>\u2022 Keep forms\/annexures naming exact device models<\/p>\n<p>\u2022 Keep labeling text consistent with intended use and application wording<\/td>\n<\/tr>\n<tr>\n<td><strong>Manufacturing license<\/strong><\/td>\n<td><strong>Class C OT devices (e.g., electrosurgical units, multiparameter patient monitors, warming high-flow pumps)<\/strong><\/td>\n<td><strong>MD-7 \u2192 MD-9<\/strong><\/td>\n<td><strong>Central Licensing Authority (CDSCO HQ)<\/strong><\/td>\n<td>\u2022 Everything from Class A\/B plus<\/p>\n<p>\u2022 Evidence aligned to the MD-9 checklist<\/p>\n<p>\u2022 Electrical safety\/EMC (e.g., IEC 60601 series)<\/p>\n<p>\u2022 Software lifecycle file (if software\/firmware present)<\/p>\n<p>\u2022 Clinical\/performance evidence proportional to risk<\/p>\n<p>\u2022 Usability (IEC 62366) where applicable<\/td>\n<td>\u2022 Build your dossier to the MD-9 checklist order<\/p>\n<p>\u2022 Early gap-assessment against standards<\/p>\n<p>\u2022 Keep a clean traceability matrix: Intended use \u2192 risks \u2192 controls \u2192 tests \u2192 labeling<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2><\/h2>\n<h2><span class=\"ez-toc-section\" id=\"Post-Market_Surveillance_PMS_Materiovigilance_%E2%80%93_Why_Is_It_an_Ongoing_Responsibility\"><\/span>Post-Market Surveillance (PMS) &amp; Materiovigilance &#8211; <span style=\"color: #2490eb;\">Why Is It an Ongoing Responsibility<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Once your OT device is on the market, the job is not complete. CDSCO (via DCGI circulars) has repeatedly emphasized the timely reporting of medical device adverse events to MvPI (Materiovigilance Programme of India). The Indian Pharmacopoeia Commission runs MvPI and publishes the official adverse event reporting forms and toolkit. Build internal SOPs so incidents move quickly from hospital to manufacturer\/importer to IPC.<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Common_Pitfalls_While_Applying_for_the_License\"><\/span>Common <span style=\"color: #2490eb;\">Pitfalls<\/span> While Applying for the License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Some misconceptions and consequent mistakes that will prevent you from getting approved are as follows:<\/p>\n<ul>\n<li>Calling it the wrong license. There\u2019s no single OT license. Your license type follows your activity (import\/manufacture\/sell) and your device\u2019s risk class.<\/li>\n<li>Forgetting MD-42 for the sales\/stocking entity. Audits by the CDSCO professionals detect it quickly.<\/li>\n<li>Vague intended use. The risk class hinges on intended use. Copy it carefully from your IFU and keep it consistent across forms and labels.<\/li>\n<li>Weak PMS loop. MvPI reporting is not optional, so document and train.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><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>At <a href=\"https:\/\/www.dueranconsultancy.com\/\">Dueran Consultant<\/a>, our job is to make the approval process easier for you. Be it Manufacturing license or Import License, we&#8217;ll provide you with complete support and guidance from the beginning. Just share with us your device details and we&#8217;ll take you through the steps needed to complete the approval process. Not only this, but we&#8217;ll also create personalized strategies to enable your business to succeed in the Indian medical device market.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you work with Operation Theatre (OT) equipment in India\u2014buying, importing, manufacturing, or selling- you live under the Medical Devices<\/p>\n","protected":false},"author":1,"featured_media":8450,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[595],"tags":[663,664,660,662,661,665],"class_list":["post-8449","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-regulatory","tag-cdsco-classification-of-medical-devices-in-operation-theatre","tag-cdsco-import-license-for-operation-theatre-medical-devices","tag-cdsco-operation-theatre-medical-devices","tag-cdsco-operation-theatre-medical-devices-license","tag-cdsco-operation-theatre-medical-equipment-license","tag-import-license-for-operation-theatre-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 Operation Theatre Medical Devices Licenses [Process]<\/title>\n<meta name=\"description\" content=\"How to secure the CDSCO Operation Theatre Medical Devices licenses. 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