{"id":48152,"date":"2022-09-03T13:44:09","date_gmt":"2022-09-03T08:14:09","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48152"},"modified":"2025-10-08T17:42:34","modified_gmt":"2025-10-08T12:12:34","slug":"cdsco-medical-device-registration-for-defibrillators","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/","title":{"rendered":"CDSCO Medical Device Registration for Defibrillators \u2013 An Overview"},"content":{"rendered":"\n<p>The Central Drug\nStandard Control Organization (CDSCO) is the national regulatory body of India.\nThe Ministry of Health &amp; Family Welfare, Government of India, oversees it\nthrough the Directorate General of Health Services. It is governed and\nregulated by the Drugs and Cosmetics Act and is responsible for the approval of\ndrugs, setting their standards, conducting clinical trials, checking the\nquality of imported drugs, etc. In order to comply with the standards set by\nMedical Device Rules 2017, the Ministry of Consumer Affairs had made a proposal\nfor CDSCO Medical Device Registration for Defibrillators, <\/p>\n\n\n\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 ez-toc-toggle\" style=\"cursor:pointer\">Page 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 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Defibrillators_as_Medical_Device\" >Defibrillators as Medical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Medical_Device_Regulation_in_India\" >Medical\nDevice Regulation in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Classification_of_Medical_Devices_in_Medical_Device_Rules_2017\" >Classification of Medical Devices\nin Medical Device Rules, 2017<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Regulatory_Authorities_of_Defibrillators_as_Class_C_Medical_Devices_in_India\" >Regulatory Authorities of Defibrillators\nas Class C Medical Devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Documents_Required_for_CDSCO_Medical_Device_Registration_for_Defibrillators\" >Documents Required for CDSCO\nMedical Device Registration for Defibrillators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Procedure_for_CDSCO_Medical_Device_Registration_for_Defibrillators\" >Procedure for CDSCO Medical Device\nRegistration for Defibrillators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Timeline_for_CDSCO_Medical_Device_Registration_for_Defibrillators\" >Timeline for CDSCO Medical Device\nRegistration for Defibrillators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Defibrillators_as_Medical_Device\"><\/span>Defibrillators as Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Defibrillators\nare devices that are used to send an electric shock or pulse to the heart for\nrestoring the normal heartbeat. This device is used to correct arrhythmia- abnormal\nheartbeats which are either too slow or too fast. If in case the heart suddenly\nstops working, defibrillators are used to make the heart start beating. <\/p>\n\n\n\n<p><strong>There are three types of defibrillators- <\/strong><\/p>\n\n\n\n<ul>\n<li>Automated External Defibrillators (AEDs)<\/li>\n\n\n\n<li>Implantable Cardioverter Defibrillators (ICDs)<\/li>\n\n\n\n<li>Wearable Cardioverter Defibrillators (WCDs)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Regulation_in_India\"><\/span>Medical\nDevice Regulation in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, the\nmarket for Medical Devices is a significant and important part of the\nhealthcare sector, especially for the purpose of preventing, diagnosing,\ntreating, and managing several ailments, impairments, diseases and Illnesses. It\nis a support system for the Indian healthcare unit and helps in performing\nimportant functions, which are stated in the National Health Policy (NHP) 2017.\nThe Medical device regulation helps in providing good quality, affordable and\nall-encompassing healthcare services in India. <\/p>\n\n\n\n<p><strong>Directorate General of Health Services (DGHS)<\/strong> had issued a notification 648 (E) published in The Official Gazette of India. The notification stated that the following criteria of medical devices would be considered as Drugs, effective from 1st April 2020-<\/p>\n\n\n\n<p>&#8220;All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either alone\/in combination with other device, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one or more specific purpose of-&#8221; <\/p>\n\n\n\n<ol>\n<li>Diagnosis, monitoring,&nbsp; prevention, alleviation or treatment of any disorder or disease <\/li>\n\n\n\n<li>Diagnosis, monitoring, treatment or alleviation of any disability or Injury <\/li>\n\n\n\n<li>Replacement, investigation, support or modification of a physiological process or of the anatomy<\/li>\n\n\n\n<li>Life support and sustaining <\/li>\n\n\n\n<li>Medical Device disinfection<\/li>\n\n\n\n<li>Conception control<\/li>\n<\/ol>\n\n\n\n<p>According to the\nnotification, the intended use of the Defibrillator is to send an electric\nshock or pulse to the heart for restoring the normal heartbeat. The risk\nclassification of the device is Medium-High level risk, which makes it\nmandatory for the device to be registered with CDSCO. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_in_Medical_Device_Rules_2017\"><\/span>Classification of Medical Devices\nin Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the Medical Device Rules 2017, the DCGI, who is the head of CDSCO, is responsible for regulating the different classes of Medical Devices as per their Risk-based classification. <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> has set up different classes of medical devices as per the level of risk associated with each device. Medical Devices are categorized into four types on the basis of Risk-Based classification, which are as follows-<\/p>\n\n\n\n<p><strong><em>Class\nA, Class B, Class C &amp; Class D Medical devices. <\/em><\/strong><\/p>\n\n\n\n<p>The level of\ndanger associated with each device increases with the increase in the Classes\nof Medical devices. The following table lists the classification of medical\ndevices on the basis of the risk involved-<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Device Class <\/strong>\n  <\/td><td>\n  <strong>Risk Involved <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class A Medical Devices <\/strong>\n  <\/td><td>\n  Low Risk \n  <\/td><\/tr><tr><td>\n  <strong>Class B Medical Devices<\/strong>\n  <\/td><td>\n  Low-Medium Risk\n  <\/td><\/tr><tr><td>\n  <strong>Class C Medical Devices<\/strong>\n  <\/td><td>\n  Medium-High Risk \n  <\/td><\/tr><tr><td>\n  <strong>Class D Medical Devices<\/strong>\n  <\/td><td>\n  High Risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Authorities_of_Defibrillators_as_Class_C_Medical_Devices_in_India\"><\/span>Regulatory Authorities of Defibrillators\nas Class C Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Authorities who are responsible for regulating the <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">CDSCO Medical Device Registration<\/a><\/strong> for Defibrillators in India are- <\/p>\n\n\n\n<ul>\n<li>Central Drug Standards Control Organization\n(CDSCO)<\/li>\n\n\n\n<li>Drug Controller General of India ( DCGI) <\/li>\n\n\n\n<li>Drugs &amp; Cosmetic Act 1940 &amp; Rules 1945<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Medical_Device_Registration_for_Defibrillators\"><\/span>Documents Required for CDSCO\nMedical Device Registration for Defibrillators<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some vital documents required for CDSCO\nMedical Device Registration for Defibrillators: <\/p>\n\n\n\n<ul>\n<li>Application Form (Form-40)<\/li>\n\n\n\n<li>ISO 13485 Certificate <\/li>\n\n\n\n<li>TR6 Challan<\/li>\n\n\n\n<li>Undertaking that only authentic details are\nprovided <\/li>\n\n\n\n<li>Power of attorney<\/li>\n\n\n\n<li>Full quality assurance certificate <\/li>\n\n\n\n<li>CE Design certificate <\/li>\n\n\n\n<li>Schedule D(I) <\/li>\n\n\n\n<li>Declaration of conformity<\/li>\n\n\n\n<li>Device master file <\/li>\n\n\n\n<li>Free sale certificate <\/li>\n\n\n\n<li>Plant master report <\/li>\n\n\n\n<li>Free Sale Certificate\/ Certificate from the\nForeign Government <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Medical_Device_Registration_for_Defibrillators\"><\/span>Procedure for CDSCO Medical Device\nRegistration for Defibrillators<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before 2006,\nMedical Devices did not have any regulations and were marketed in India without\nany law governing them. In the years after 2006, the CDSCO enacted a regulation\nwhich required all Medical Devices which are Manufactured, Imported or sold in\nthe market to be registered with CDSCO first. The procedure for CDSCO Medical\nDevice registration for Defibrillators is-<\/p>\n\n\n\n<ol>\n<li><strong>Determine\nwhether the Medical Devices require registration or not<\/strong>: The first step is\nto check with the Medical Devices and IVDs list to check if the medical device\nis notified or not. All the notified medical devices are required to obtain\nregistration before they are marketed in India. Defibrillators must be\nregistered as medical devices under CDSCO and are notified devices. <\/li>\n\n\n\n<li><strong>Risk\nBased Classification of Medical Devices: <\/strong>The notified devices which are\nrequired to be registered with CDSCO are then identified on the basis of risks\ninvolved with them. Defibrillators are classified as Class C medical devices\nbecause of Medium- High level risk involved with them.<\/li>\n\n\n\n<li><strong>Appointment of Indian Authorized Agent\n(IAA):<\/strong> An Indian Authorized Agent is appointed in case if the manufacturer\nis not an Indian. The IAA acts as a representative on behalf of the\nmanufacturer to conduct all his official duties in India. <\/li>\n\n\n\n<li><strong>Technical Documentation: <\/strong>All the necessary\ndocuments are required to be submitted to the respective authorities in order\nto obtain a Registration License.<\/li>\n\n\n\n<li><strong>Obtain Registration and License: <\/strong>After\nall the necessary documents are submitted to the correct authorities, the\nregistration license is obtained by the manufacturer.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_CDSCO_Medical_Device_Registration_for_Defibrillators\"><\/span>Timeline for CDSCO Medical Device\nRegistration for Defibrillators<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The timeline for\nCDSCO Medical Device Registration for Defibrillators is 6-9 months after the\napplication process is completed. The Medical Device registration is valid for\nthree years. In order to renew the registration, the applications are required\nto be submitted six months before the date of expiry. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Global market for Defibrillators was calculated at US$ 11.4 billion in 2021 and is expected to reach US$ 18.2 billion by 2026. There has definitely been significant market growth in the medical device industry because of various factors. Since Defibrillators fall in the category of Class C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for Defibrillators.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-x-ray-machine\/\">CDSCO Medical Device Registration for X-Ray Machine<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization (CDSCO) is the national regulatory body of India. The Ministry of Health &amp; Family Welfare, Government of India, oversees it through the Directorate General of Health Services. It is governed and regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, setting their standards, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48153,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2687],"acf":{"service_id":"508"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":3559,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48152"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=48152"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48152\/revisions"}],"predecessor-version":[{"id":70173,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48152\/revisions\/70173"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48153"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}