{"id":45783,"date":"2022-07-29T16:33:10","date_gmt":"2022-07-29T11:03:10","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=45783"},"modified":"2025-10-08T17:58:45","modified_gmt":"2025-10-08T12:28:45","slug":"cdsco-registration-certificate-for-ct-scan-machine","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-certificate-for-ct-scan-machine\/","title":{"rendered":"An Overview of CDSCO Registration Certificate for CT Scan Machine"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The CDSCO is the National Regulatory Authority (NRA) of India, which works under <strong>the Directorate General of Health Services (DGHS)<\/strong>, Ministry of Health &amp; Family Welfare, Government of India. CDSCO, a body that works under the Drugs and Cosmetics Act, is accountable for the approving of drugs and laying down the standard for drugs, to conduct clinical trials, to take control over the quality of Imported Drugs, etc. From April 1, 2021, CDSCO, a government agency under the Ministry of Health and Family Welfare, has issued an order to regulate CT scanners, all implantable devices and MRI machines. Medical devices such as implantable devices, CT scans, MRIs, defibrillators, PET scanners, X-ray machines and cell separators used in dialysis will all require an import\/manufacturing licence from either the Central Licensing Authority or a State Licensing Authority in order to enter the country. In this blog, we are going to discuss <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration<\/strong><\/a> Certificate for CT Scan Machine.<\/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-registration-certificate-for-ct-scan-machine\/#Regulatory_Bodies_Responsible_for_the_Registration_of_Medical_Devices_in_India\" >Regulatory Bodies Responsible for the Registration of 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-2\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-certificate-for-ct-scan-machine\/#Medical_Devices_classification_under_CDSCO\" >Medical Devices classification under CDSCO<\/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-registration-certificate-for-ct-scan-machine\/#Who_are_eligible_for_CDSCO_Registration_Certificate\" >Who are eligible for CDSCO Registration Certificate?<\/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-registration-certificate-for-ct-scan-machine\/#Important_Documents_required_for_CDSCO_Registration_Certificate_for_CT_Scan_Machine\" >Important Documents required for CDSCO Registration Certificate for CT Scan Machine<\/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-registration-certificate-for-ct-scan-machine\/#Procedure_for_Obtaining_Online_CDSCO_Registration_Certificate_for_CT_Scan_Machine\" >Procedure for Obtaining Online CDSCO Registration Certificate for CT Scan Machine<\/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-registration-certificate-for-ct-scan-machine\/#Time_taken_for_CDSCO_Registration_process_of_Medical_Devices\" >Time taken for CDSCO Registration process of Medical Devices:<\/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-registration-certificate-for-ct-scan-machine\/#ImportManufacturing_License_under_Medical_Devices_Rules_2017\" >Import\/Manufacturing License under Medical Devices Rules, 2017<\/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-registration-certificate-for-ct-scan-machine\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Bodies_Responsible_for_the_Registration_of_Medical_Devices_in_India\"><\/span>Regulatory Bodies Responsible for the Registration of Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li><strong>Central\nDrugs Standards Control Organization (CDSCO):<\/strong> It is the main regulatory\nbody in India, under the Directorate General of Health Services (DGHS),\nMinistry of Health &amp; Family welfare, which regulates pharmaceuticals and\nmedical devices. <\/li>\n\n\n\n<li><strong>DCGI: <\/strong>It is the\nhead of CDSCO, and is responsible for approval of quality drugs and cosmetics\nto be sold in the country and to regulate clinical trials. <\/li>\n\n\n\n<li><strong>The Drugs\nand Cosmetic Act and Rules: <\/strong>These are the set of rules that regulates\nthe Manufacture, Import &amp; Distribution of Drugs in India. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Devices_classification_under_CDSCO\"><\/span>Medical Devices classification under CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In\ngeneral, medical equipment are categorised based on the risks they pose;\nhowever, a medical device&#8217;s absolute risk classification is determined by how\nit is intended to be used and what its intended purpose is. Medical Devices IVD\nare classified into four categories based on their evidence for use and risk.\nUnder the new regulations, devices are regulated using a risk-based approach. A\ndevice&#8217;s intended use, as well as its technological properties, influence how\nmuch regulation it receives. The new system divides devices into four classes\n&#8211;&nbsp;A, B, C, and D,&nbsp;where&nbsp;Class A and B presenting the least risk\nto patients and Class C and D presenting the greatest risk.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_are_eligible_for_CDSCO_Registration_Certificate\"><\/span>Who are eligible for CDSCO Registration Certificate?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There are\na few applicants who are allowed to apply for an online CDSCO Registration\ncertificate: <\/p>\n\n\n\n<ul>\n<li>Importers,<\/li>\n\n\n\n<li>Companies, <\/li>\n\n\n\n<li>Indian Agents, and <\/li>\n\n\n\n<li>Foreign Enterprises holding Indian Subsidiary. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Documents_required_for_CDSCO_Registration_Certificate_for_CT_Scan_Machine\"><\/span>Important Documents required for CDSCO Registration Certificate for CT Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare some vital documents required for CDSCO Registration Certificate for CT\nScan Machine:<\/p>\n\n\n\n<ul>\n<li>Form 40<\/li>\n\n\n\n<li>ISO 13485 Certificate <\/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>Device master file <\/li>\n\n\n\n<li>Plant master report <\/li>\n\n\n\n<li>Undertaking that only authentic details are\nprovided <\/li>\n\n\n\n<li>Free sale certificate\/ certificate from the\nforeign government <\/li>\n\n\n\n<li>Certificate of Marketability from GHTF (The\nEuropean Union, Canada, Australia, Japan &amp; The United States) <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Obtaining_Online_CDSCO_Registration_Certificate_for_CT_Scan_Machine\"><\/span>Procedure for Obtaining Online CDSCO Registration Certificate for CT Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nRegistration process for CDSCO is completely online. Here are the steps to get\nregistered with CDSCO through the online CDSCO Portal:<\/p>\n\n\n\n<ol>\n<li>Go to the CDSCO Registration portal.<\/li>\n\n\n\n<li>After that, you need to apply for registration by filling the application form (Form 40).<\/li>\n\n\n\n<li>Upon accessing the Application Registration page, enter all the requested information, including:<\/li>\n\n\n\n<li>Type of Applicant,<\/li>\n\n\n\n<li>Name,<\/li>\n\n\n\n<li>Username,<\/li>\n\n\n\n<li>Password,<\/li>\n\n\n\n<li>Mobile Number,<\/li>\n\n\n\n<li>Email ID.<\/li>\n<\/ol>\n\n\n\n<p><strong>Complete the Registered Indian Address Form,\nwhich includes the following information:<\/strong><\/p>\n\n\n\n<ul>\n<li>Name and Type of Organization,<\/li>\n\n\n\n<li>CIN,<\/li>\n\n\n\n<li>Phone Number,<\/li>\n\n\n\n<li>Address,<\/li>\n\n\n\n<li>Upload the proof of the business address.<\/li>\n\n\n\n<li>After submitting a complete application for the\nregistration, you will receive a confirmation link to your registered email\naddress to confirm your registration. Then you must click the provided link to\nactivate your CDSCO account.<\/li>\n\n\n\n<li>Upon clicking the confirmation link, the\napplication for CDSCO Registration for CT Scan Machine will be forwarded to the\nrelevant Department for approval.<\/li>\n\n\n\n<li>Once your CDSCO Registration for CT Scan Machine\napplication has been approved, an approval email will be sent to your\nregistered email address. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_taken_for_CDSCO_Registration_process_of_Medical_Devices\"><\/span>Time taken for CDSCO Registration process of Medical Devices: <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Commonly, it takes around 6 to 8 months to <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">register Medical devices in India<\/a><\/strong>, unless there\u2019s a review required by Technical Presentation or Subject Expert Committee (SEC). In case, if the Technical Presentation or Subject Expert Committee review is required, the registration process is extended by 3 to 6 months. Once registration is completed, the registration certificate remains valid for up to 3 years from the registration date, unless it is cancelled or suspended by the DGCI authority. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ImportManufacturing_License_under_Medical_Devices_Rules_2017\"><\/span>Import\/Manufacturing License under Medical Devices Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the provisions of\nthe Medical Devices Rules, 2017, the existing Importer\/manufacturer of\nmedical&nbsp;devices who has applied for a&nbsp;licence for Import\/\nManufacturing, in&nbsp;the Central Licencing Authority or State Licensing\nAuthority will be accepted as valid. Devices imported or manufactured, can be\nimported for up to six months after the order has been placed. Additionally,\nthe permit can remain valid until a decision is made by the Central Licencing\nAuthority or the State Licensing Authority.<\/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>Over the next few years, India&#8217;s medical device workspace is likely to expand due to more people caring about their health, an emerging middle class, and government health programmes. In the year 2017, the Medical Device Rules were put out by the Indian government to change the way medical devices are regulated. The rules went into effect in January 2018, and the Central Drugs Standard Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare, is in charge of making sure devices follow the rules. Before 2005, there were no rules about medical devices in India. But today, the Medical Device Rule states that certain types of medical devices have to go through a registration process. Even though the list of regulatory standards is long, the CDSCO sometimes adds new items to it.&nbsp;<\/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-devices-manufacturing-registration-requirement\/\">CDSCO Medical Devices Manufacturing Registration Requirement<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CDSCO is the National Regulatory Authority (NRA) of India, which works under the Directorate General of Health Services (DGHS), Ministry of Health &amp; Family Welfare, Government of India. CDSCO, a body that works under the Drugs and Cosmetics Act, is accountable for the approving of drugs and laying down the standard for drugs, to [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":45785,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2541],"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":4909,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45783"}],"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=45783"}],"version-history":[{"count":12,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45783\/revisions"}],"predecessor-version":[{"id":70179,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45783\/revisions\/70179"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/45785"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=45783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=45783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=45783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}