{"id":12185,"date":"2022-10-15T05:32:46","date_gmt":"2022-10-15T05:32:46","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=12185"},"modified":"2022-10-15T05:32:48","modified_gmt":"2022-10-15T05:32:48","slug":"cdsco-registration-for-mri-scan-machine","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-mri-scan-machine\/","title":{"rendered":"CDSCO Registration for MRI Scan Machine &#8211; An Overview"},"content":{"rendered":"\n<p>MRI or Magnetic Resonance Imaging; it&#8217;s a type of scan that uses strong magnetic fields &amp; radio waves to produce detailed images of the body inside the machine. It is used to detect diseases, diagnose them &amp; track their progress. In 2021, the Ministry of Health &amp; Family, Government of India, has notified the list of equipment\/devices which will be regulated as drugs. As per the order, the manufacturers or importers of equipment &amp; medical devices like <strong>MRI equipment<\/strong>, CT Scan Machines, x-ray machines, dialysis, etc., and all implantable medical devices, will require a manufacturing or import License from State Licensing Authority or Central Licensing Authority, respectively. In this write-up, we will discuss CDSCO Registration for MRI Scan Machine.<\/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-6a3ab3bdcfae2\" 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-6a3ab3bdcfae2\"  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-mri-scan-machine\/#An_Overview_of_CDSCO\" title=\"An Overview of CDSCO\">An Overview of 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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-mri-scan-machine\/#Different_Classes_of_Medical_Devices_in_India\" title=\"Different Classes of Medical\nDevices in India\">Different Classes of Medical\nDevices 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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-mri-scan-machine\/#Documents_Required_for_CDSCO_Registration_for_MRI_Scan_Machine\" title=\"Documents Required for CDSCO\nRegistration for MRI Scan Machine\">Documents Required for CDSCO\nRegistration for MRI Scan Machine<\/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-mri-scan-machine\/#Procedure_for_CDSCO_Registration_for_MRI_Scan_Machine\" title=\"Procedure for CDSCO\nRegistration for MRI Scan Machine\">Procedure for CDSCO\nRegistration for MRI 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:\/\/swaritadvisors.com\/blog\/cdsco-registration-for-mri-scan-machine\/#Renewal_of_CDSCO_Registration_for_MRI_Scan_Machine\" title=\"Renewal of CDSCO Registration\nfor MRI Scan Machine\">Renewal of CDSCO Registration\nfor MRI 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-mri-scan-machine\/#Post_Compliance_after_Getting_Registration_Certificate\" title=\"Post Compliance after Getting\nRegistration Certificate\">Post Compliance after Getting\nRegistration Certificate<\/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-mri-scan-machine\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"An_Overview_of_CDSCO\"><\/span>An Overview of CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>India\nis one of the growing nations in the pharmaceutical business, and there are\nseveral factors like a huge population, affordable medical facilities, and\ngrowing health awareness&amp; better research facilities that have given rise\nto the development &amp; manufacturing of the pharma business in India.\nHowever, with the growth of the pharmaceutical industry in India, there are\npossibilities for the sale or purchase of medical devices &amp; equipment\nwithout jurisdiction or illegally.<\/p>\n\n\n\n<p>That\u2019s why the Indian Government has set up <strong><em>CDSCO (Central Drug Standards Control Organisation)<\/em><\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>, which is the primary legislative body &amp; has been responsible for the control, management, and regulation of pharmaceuticals &amp; medical devices in India apart from the appointment of DCGI and has conferred the responsibility of undertaking assessment, approval &amp; regulation of further compliances (sale, import, export, distribution) in the matters of medicinal drugs &amp; medical devices (including any new or existing devices\/drugs) as per the provisions of the Drugs &amp; Cosmetics Act, 1940.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_Classes_of_Medical_Devices_in_India\"><\/span>Different Classes of Medical\nDevices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Provisions\nunder the Act related to the manufacture, sale, import &amp; distribution of\nmedical devices are regulated under the Drugs &amp; Cosmetics Act. Under the\nMDR, 2017, all medical devices in India have been categorised into 4 different\ncategories depending on their usability &amp; risk involved, as mentioned\nbelow:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Different\n  Class<\/strong>\n  <\/td><td>\n  <strong>Risk <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  A <\/strong>\n  <\/td><td>\n  Low-Risk (Devices such as tongue depressors,\n  thermometers, etc.)\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  B <\/strong>\n  <\/td><td>\n  Low-Moderate Risk (Such as Suction device,\n  Hypodermic Needles, etc.)\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  C<\/strong>\n  <\/td><td>\n  Moderate-High Risk (Such as Lung Ventilator,\n  etc.)\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  D<\/strong>\n  <\/td><td>\n  High-Risk (Such as implantable devices, etc.)\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><strong>Note:<\/strong> Class A &amp; Class B medical devices are considered to be less risky &amp; moderate devices, for which the application manufacture devices in India must be filed to the SLA (State Licensing Authority). On the other side, Class C and Class D are high &amp; very high-risk devices, and the application for the same has to be filed to the CLA (Central Licensing Authority).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Registration_for_MRI_Scan_Machine\"><\/span>Documents Required for CDSCO\nRegistration for MRI Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare some vital documents required for CDSCO Registration for MRI Scan Machine:<\/p>\n\n\n\n<ol><li>Duly-filled application form;<\/li><li>CE Design Certificate;<\/li><li>Plant Master Report;<\/li><li>Device Master File;<\/li><li>Undertaking that all the details provided by the applicant is genuine &amp; authentic;<\/li><li>Full Quality Assurance Certificate;<\/li><li>Get an FSC (Free Sale Certificate) or Certificate from the Foreign Government;<\/li><li>Details of the actual site;<\/li><li>Name, address &amp; contact details of the manufacturer.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_MRI_Scan_Machine\"><\/span>Procedure for CDSCO\nRegistration for MRI Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the procedure for CDSCO Registration for MRI Scan Machine:<\/p>\n\n\n\n<p><strong>Step 1: Know Whether the Medical Device required is under notified list or not<\/strong>: The CDSCO has provided a list of notified-medical devices that need to obtain Registration under the Drugs &amp; Cosmetics Act, 1940, and as per the MDR, 2017. There may be any medical devices that haven&#8217;t been notified by the CDSCO, or in the case of new medical devices in India, the manufacturer or importer must obtain a NOC in this case. <\/p>\n\n\n\n<p><strong>Step 2: Appoint an IAA (for Foreign Entity\nor Manufacturer)<\/strong>: For Foreign manufacturers, it is compulsory to\nappoint an IAA (Indian Authorised Agent) in India, who shall be the contact\nperson for the inspection authorities at the time of CDSCO Registration for MRI\nScan Machine, help the manufacturer in the registration process, device\napprovals, and vigilance adverse event reporting. The Indian Authorisation must\nhave a Wholesale Drug License.<\/p>\n\n\n\n<p><strong>Step 3: Filling of Application form<\/strong>: In\nthis step, the manufacturer or importer of the MRI Scan Machine shall be\nrequired to submit the Registration Form along with the relevant documents\n&amp; prescribed fees on the CDSCO portal.<\/p>\n\n\n\n<p><strong>Step 4: Issuance of Registration\nCertificate<\/strong>: Once the applicant submits the application\nform &amp; documents and pays the fees, then the authority may send a query via\nan inquiry letter to the manufacturer or from the authorised representative of\nthe importer along with the timeline within which the query should be answered.\nOnce the authority is satisfied, the authority may issue a License. After\nobtaining CDSCO Registration for MRI Scan Machine, the manufacturer or his\/her\nauthorised representative may apply for an importer license.<\/p>\n\n\n\n<p><strong><em>Note:\nCDSCO Registration for MRI Scan Machine is valid for 3 years from the date of\nissue of Registration Certificate unless cancelled or suspended by the DGCI\nauthority.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renewal_of_CDSCO_Registration_for_MRI_Scan_Machine\"><\/span>Renewal of CDSCO Registration\nfor MRI Scan Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The renewal application for CDSCO Registration for MRI Scan Machine shall be filed at least 9 months before the expiry of CDSCO Registration for MRI Scan Machine. Though there are no extra documents required for the renewal of Registration, it shall be necessary for the Certificate owner to provide a copy of the PMF (Plant Master File) &amp; Device Master File or DMF where there are no changes in the Device Master File and Plant Master File.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Post_Compliance_after_Getting_Registration_Certificate\"><\/span>Post Compliance after Getting\nRegistration Certificate<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare some post-compliance after obtaining a Registration Certificate:<\/p>\n\n\n\n<ol><li>In case of any change that has been taken place regarding the address of the registered factory premises or office or constitution of the firm, the <strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\">Medical Device manufacturer<\/a><\/strong> or authorised representative of the importer to intimate the Licensing Authority about the same in writing.<\/li><li>In case of any change in the existing Registration, the Certificate shall be valid for 3 months from the date on which the change has taken place and at this time, the authorised representative or manufacturer of Medical Devices shall be required to get a new Registration Certificate.<\/li><\/ol>\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> In 2019, the Indian MRI equipment market was Rs. 1778.5 crores and 290 units (by volume) and is expected to grow more in the upcoming period. More new product launches and technological advancements are expected to create market growth for medical devices in India. Since MRI Scan Machine falls under the Class \u2013C medical device category, there is a mandatory requirement for Medical Device Registration. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-8-and-form-md-10\/\">What is the Meaning of Form MD-8 and Form MD-10?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>MRI or Magnetic Resonance Imaging; it&#8217;s a type of scan that uses strong magnetic fields &amp; radio waves to produce detailed images of the body inside the machine. It is used to detect diseases, diagnose them &amp; track their progress. In 2021, the Ministry of Health &amp; Family, Government of India, has notified the list [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":12189,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12185"}],"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\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=12185"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12185\/revisions"}],"predecessor-version":[{"id":12191,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12185\/revisions\/12191"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/12189"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=12185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=12185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=12185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}