{"id":11350,"date":"2022-07-11T12:52:21","date_gmt":"2022-07-11T12:52:21","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11350"},"modified":"2022-07-11T12:52:23","modified_gmt":"2022-07-11T12:52:23","slug":"cdsco-registration-for-ct-scan-machine","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/","title":{"rendered":"CDSCO Registration for CT Scan Machine: An Overview"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Ministry of Health &amp; Family Welfare, Government of India, has notified the list of tools or devices that will regulate drugs. This regulation was already effective by April 01, 2021. According to the order, the manufacturers\/ importers of medical devices and equipment like CT Scan devices, MRI devices, PET devices, dialysis machines, defibrillators, X-ray machines, bone marrow cell separators, and all implantable medical tools and devices will require manufacturing or import license by the Central Licensing Authority and State Licensing Authority. We will discuss the CDSCO Registration for CT Scan Machine in this Article.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3a866bd6146\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3a866bd6146\"  aria-label=\"Toggle\" \/><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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#List_of_equipment_Devices_that_will_require_CDSCO_Registration\" title=\"List of equipment &amp;Devices that will\nrequire CDSCO Registration\">List of equipment &amp;Devices that will\nrequire CDSCO Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Ultrasound_Devices_under_CDSCO_Regulation\" title=\"Ultrasound Devices under CDSCO\nRegulation\">Ultrasound Devices under CDSCO\nRegulation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Risk-Based_Classifications_for_Medical_Devices_under_CDSCO\" title=\"Risk-Based Classifications for Medical\nDevices under CDSCO\">Risk-Based Classifications for Medical\nDevices under CDSCO<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Who_can_apply_for_CDSCO_Registration_for_CT_Scan_Machine_in_India\" title=\"Who can apply for CDSCO Registration for\nCT Scan Machine in India?\">Who can apply for CDSCO Registration for\nCT Scan Machine 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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Documents_required_for_the_CDSCO_Registration_for_CT_Scan_Machine\" title=\"Documents required for the CDSCO\nRegistration for CT Scan Machine.\">Documents required for the CDSCO\nRegistration 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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Procedure_for_Obtaining_CDSCO_Registration_for_CT_Scan_Machine\" title=\"Procedure for Obtaining CDSCO\nRegistration for CT Scan Machine.\">Procedure for Obtaining CDSCO\nRegistration 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-7\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Time_taking_and_Validity_for_CDSCO_Registration_for_CT_Scan_Machine\" title=\"Time taking and Validity for CDSCO\nRegistration for CT Scan Machine\">Time taking and Validity for CDSCO\nRegistration 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-8\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-ct-scan-machine\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"List_of_equipment_Devices_that_will_require_CDSCO_Registration\"><\/span>List of equipment &amp;Devices that will\nrequire CDSCO Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Sr. No<\/strong>.\n  <\/td><td>   <strong>List of equipment and   devices that will require import\/manufacturing license<\/strong>   <\/td><\/tr><tr><td>\n  1. \n  <\/td><td>\n  All implantable medical devices\n  <\/td><\/tr><tr><td>\n  2.\n  <\/td><td>\n  CT scan equipment\n  <\/td><\/tr><tr><td>\n  3.\n  <\/td><td>\n  MRI equipment\n  <\/td><\/tr><tr><td>\n  4.\n  <\/td><td>\n  Defibrillators\n  <\/td><\/tr><tr><td>\n  5.\n  <\/td><td>\n  PET equipment\n  <\/td><\/tr><tr><td>\n  6.\n  <\/td><td>\n  Dialysis Machine\n  <\/td><\/tr><tr><td>\n  7.\n  <\/td><td>\n  X-ray Machine\n  <\/td><\/tr><tr><td>\n  8.\n  <\/td><td>\n  Bone marrow cell separator\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ultrasound_Devices_under_CDSCO_Regulation\"><\/span>Ultrasound Devices under CDSCO\nRegulation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The New Device third Notification has amended the date of notifications dated October 16, 2016, and has brought ultrasound medical devices under CDSCO regulation from November 01, 2020, extending to November 01, 2021.<\/p>\n\n\n\n<p>We will observe the\nCDSCO&#8217;s progress and shall implement the new regulatory scope for development.\nIndia is regarded as one of the top worldwide medical devices markets with its\nunique offer towards device imports.<\/p>\n\n\n\n<p>The country&#8217;s agency for\nregulation of equipment, CDSCO, has classified medical devices that head\nthrough the DCGI (Drug Controller General of India) and has classified medical\ndevices into four classes per regulation (A, B, C, D).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk-Based_Classifications_for_Medical_Devices_under_CDSCO\"><\/span>Risk-Based Classifications for Medical\nDevices under CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical Devices under\nCDSCO are generally based on the risks and the medical devices intended use and\npurpose, and an accurate risk-based classification is done. The medical devices\nunder the CDSCO classification have a larger group of devices, such as stents\n&amp; cannulas, in more subgroups that are specific.<\/p>\n\n\n\n<ul><li><strong>Low Risk\n(Class A)<\/strong>: Surgical dressing, Absorbent cotton wools, alcohol swabs, etc.<\/li><li><strong>Low\nModerate Risk (Class B)<\/strong>: BP monitoring device, Thermometer, disinfectants\netc.<\/li><li><strong>Moderate\nHigh-Risk (Class C)<\/strong>: Haemodialysis catheter, Implants etc.<\/li><li><strong>High Risk\n(Class D)<\/strong>: heart valve, Angiographic guide wire.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_can_apply_for_CDSCO_Registration_for_CT_Scan_Machine_in_India\"><\/span>Who can apply for CDSCO Registration for\nCT Scan Machine in India?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are the\napplicant who can apply for online CDSCO Registration for CT Scan Machine in\nIndia: <\/p>\n\n\n\n<ol><li>Indian Agents;<\/li><li>Corporates;<\/li><li>Importers;<\/li><li>Foreign\nEnterprises are holding Indian Subsidiary.<\/li><\/ol>\n\n\n\n<p><strong><em>Note: A manufacturing unit cannot\nregister directly on the website\/portal. A corporate needs to create login\nauthorisation for the manufacturing team to log in on the portal.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_the_CDSCO_Registration_for_CT_Scan_Machine\"><\/span>Documents required for the CDSCO\nRegistration for CT Scan Machine.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Form 40<\/li><li><strong>ISO 13485 Certificate<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/ISO_13485\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup><\/li><li>Full Quality Assurance Certificate<\/li><li>CE Design Certificate<\/li><li>Undertaking that all details provided is authentic<\/li><li>Either a Free Sale Certificate\/ Certificate from the Foreign Government<\/li><li>Certificate of Marketability from GHTF (Australia, Japan, Canada, the European Union, and the UnitedStates);<\/li><li>Plant Master Report<\/li><li>Device Master File<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Obtaining_CDSCO_Registration_for_CT_Scan_Machine\"><\/span>Procedure for Obtaining CDSCO\nRegistration for CT Scan Machine.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO Registration is\nentirely Online. Following are the procedures for obtaining CDSCO Registration\nthrough the online CDSCO Portal:<\/p>\n\n\n\n<p><strong>Step 1<\/strong>: First, you have to visit the CDSCO Registration portal.<\/p>\n\n\n\n<p><strong>Step 2<\/strong>: Then you need to apply for registration for that; you have\nto go to the Registration motive page and click on submit.<\/p>\n\n\n\n<p><strong>Step 3<\/strong>: Once you open the Application Registration page, fill in\nall the vital information as provided in the application form, such as:<\/p>\n\n\n\n<ul><li>Applicant Type;<\/li><li>Name;<\/li><li>User Names;<\/li><li>Password;<\/li><li>Mobile Number;<\/li><li>Email ID.<\/li><\/ul>\n\n\n\n<p><strong>Fill out the Registered Indian Address Form that contains information\nlike:<\/strong><\/p>\n\n\n\n<ul><li>Organisation Name &amp; Type;<\/li><li>CIN;<\/li><li>Contact Number;<\/li><li>Address; <\/li><li>Upload the Corporate Address Proof.<\/li><\/ul>\n\n\n\n<p><strong>Step 4: <\/strong>Once you apply correctly, you will get a confirmation link\nto your registered email ID to verify the registration. Then you have to click\non the link to activate your account on the CDSCO portal.<\/p>\n\n\n\n<p><strong>Step 5:<\/strong> After the confirmation link is clicked, the application for\nCDSCO Registration for CT Scan Machine will be sent to the concerned Department\nfor Approval.<\/p>\n\n\n\n<p><strong>Step 6: <\/strong>After the<a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\"><strong> CDSCO Registration<\/strong><\/a> for CT Scan Machine application is approved, send an approval email to your registered email ID. If the application is rejected, an email for rejection will send to your email ID. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_taking_and_Validity_for_CDSCO_Registration_for_CT_Scan_Machine\"><\/span>Time taking and Validity for CDSCO\nRegistration for CT Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If the DGCI does not ask\nfor a Technical Presentation or subject Expert Committee (SEC) audit, it will\ntake almost 6 to 9 months to get a Medical Devices Registration. If where\nTechnical Presentation or Subject Expert Committee (SEC) audit is required, it\nmay take an additional 3 to 6 months.<\/p>\n\n\n\n<p>After obtaining, the\nRegistration Certificate shall be valid for three years from the date of grant\nof registration unless suspended\/ cancelled through the DGCI Authority for good\nreasons.<\/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 medical industry is\nlooking at two critical developments in 2021: whether it will make any\nimprovement to propose separate legislation to control medical equipment under\nCDSCO and whether the required licenses for import of medical equipment will be\ngiven promptly by the CDSCO. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health &amp; Family Welfare, Government of India, has notified the list of tools or devices that will regulate drugs. This regulation was already effective by April 01, 2021. According to the order, the manufacturers\/ importers of medical devices and equipment like CT Scan devices, MRI devices, PET devices, dialysis machines, defibrillators, X-ray [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":11351,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[1043],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11350"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=11350"}],"version-history":[{"count":3,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11350\/revisions"}],"predecessor-version":[{"id":11354,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11350\/revisions\/11354"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11351"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11350"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11350"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11350"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}