{"id":48000,"date":"2022-09-02T14:05:21","date_gmt":"2022-09-02T08:35:21","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48000"},"modified":"2022-09-02T14:05:23","modified_gmt":"2022-09-02T08:35:23","slug":"cdsco-medical-device-registration-for-mri-machine","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-mri-machine\/","title":{"rendered":"How to Get CDSCO Medical Device Registration for MRI Machine?"},"content":{"rendered":"\n<p>The CDSCO (Central Drugs Standard Control Organization) published an order on April 18, 2021, defining all implanted devices, MRI equipment, &amp; other medical devices as drugs, with an April 1 effective date. The importer or manufacturer of such devices is required to obtain an import or production licence from the Central Licensing Authority under Order No. S.O. 775(E), dated February 8, 2019. All implantable medical devices, including C.T. scans, MRI machines, Defibrillators, PET, Dialysis, X-ray, and bone marrow cell separator equipment, fall under this category. Because of this, if an existing importer or manufacturer of one of the devices listed earlier applies for a licence under the MDR of 2017, the application will be approved, and the importer or manufacturer may continue to import or produce such devices. This article will discuss CDSCO Medical Device Registration for MRI machines. <\/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-mri-machine\/#Brief_Introduction_to_MRI_Machine\" >Brief Introduction to MRI\nMachine<\/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-mri-machine\/#Regulatory_Bodies_for_the_CDSCO_Medical_Device_Registration_in_India\" >Regulatory Bodies for the CDSCO\nMedical Device Registration 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-mri-machine\/#Classification_of_Medical_Devices\" >Classification of Medical\nDevices<\/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-mri-machine\/#Risk_Based_Classifications_for_Medical_Devices_under_CDSCO\" >Risk Based Classifications for\nMedical Devices under CDSCO<\/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-mri-machine\/#Documents_Required_to_Obtain_CDSCO_Medical_Device_Registration_for_MRI_Machine\" >Documents Required to Obtain\nCDSCO Medical Device Registration for MRI 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-medical-device-registration-for-mri-machine\/#Process_to_Obtain_CDSCO_Medical_Device_Registration_for_MRI_Machine\" >Process to Obtain CDSCO Medical\nDevice Registration for MRI 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:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-mri-machine\/#Time_Taken_for_CDSCO_Medical_Device_Regulation_for_MRI_Machine\" >Time Taken for CDSCO Medical\nDevice Regulation for MRI 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:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-mri-machine\/#Renewal_of_the_CDSCO_Medical_Device_Registration_for_MRI_Machine\" >Renewal of the CDSCO Medical\nDevice Registration for MRI Machine<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-mri-machine\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Brief_Introduction_to_MRI_Machine\"><\/span>Brief Introduction to MRI\nMachine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The non-invasive imaging method known as <strong>MRI (Magnetic Resonance Imaging)<\/strong><sup><a href=\"https:\/\/www.nibib.nih.gov\/science-education\/science-topics\/magnetic-resonance-imaging-mri\"><strong>[1]<\/strong><\/a><\/sup> produces detailed three-dimensional anatomical images. It is based on cutting-edge technology which excites &amp; detects changes in the rotational axis of hydrogen nuclei (protons) in the water, which makes up biological tissues. It is widely used to detect, diagnose, and track disease progression. Powerful magnets are used in MRI to produce a strong magnetic field that forces the body&#8217;s protons to align with it. When the patient pulses a radio frequency current, the protons packets are excited and align their axis, forming an equilibrium against the magnetic field&#8217;s pull. When the radio frequency field is off, its magnetic vectors return to their resting state, causing energy to be generated in the form of a radio wave, which can be detected by MRI sensors. The molecules&#8217; surroundings and chemical composition impact the amount of energy released, and the time it takes for the protons to realign with a magnetic field and the number of transmitted radio frequencies. Doctors can determine various tissue and abnormalities types based on this magnetic resonance and the lack thereof. To receive an MRI machine, a patient must be placed inside a massive electromagnet magnet and maintain extreme stillness throughout the imaging process to prevent the image from superimposing incorrectly. Before or during the MRI, a patient may receive intravenous contrast agents (usually containing the element gadolinium) to speed up (T1 and T2 relaxation time), which causes the pace at which protons realign with the magnetic field to undergo a change.\u00a0 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Bodies_for_the_CDSCO_Medical_Device_Registration_in_India\"><\/span>Regulatory Bodies for the CDSCO\nMedical Device Registration in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>CDSCO<\/strong>\nis the top regulatory body in India, under the Directorate General of Health\nServices (DGHS) &amp; Ministry of Health &amp; Family Welfare that regulates\ndrugs &amp; medical devices.<\/li><li><strong>The Drugs\nand Cosmetic Act &amp; Rules:<\/strong> These rules regulate the manufacture, import,\nand distribution of Drugs &amp; medical devices in India.<\/li><li><strong>DCGI:<\/strong>\nIt is the head of the CDSCO and is responsible for approving quality drugs,\nmedical devices and cosmetics to be sold in India and regulating clinical\ntrials.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices\"><\/span>Classification of Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical devices under CDSCO have been classified into two categories, as given below:<\/p>\n\n\n\n<ol><li><strong>Notified Medical Devices<\/strong><\/li><li>As per Rule 4 of medical devices rule 2017,\nnotified medical devices are those whose registration is mandatory.<\/li><li>Notified medical devices comprise 37 products\nthat must be CDSCO Certified.<\/li><li><strong>Non-Notified Medical Devices<\/strong><\/li><li>As per the new amendment issued by CDSCO,\ndevices such as implants, instruments and apparatus, irrespective of their\nusage for a distinct purpose, will fall under non-notified medical devices.<\/li><li>Non-notified medical devices include 313 medical\nproducts, which must be CDSCO Certified.<\/li><\/ol>\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\nMedical Devices under CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical devices have been classified into different categories depending on risk type:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Class <\/strong>\n  <\/td><td>\n  <strong>Risk-Based<\/strong>\n  <\/td><td>\n  <strong>Examples <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>A<\/strong>\n  <\/td><td>\n  Low\n  <\/td><td>\n  Syringes, Surgical dressings, etc.\n  <\/td><\/tr><tr><td>\n  <strong>B<\/strong>\n  <\/td><td>\n  Moderate low \n  <\/td><td>\n  Pregnancy kits, Surgical gloves, etc.\n  <\/td><\/tr><tr><td>\n  <strong>C<\/strong>\n  <\/td><td>\n  Moderate high \n  <\/td><td>\n  Anaesthesia, Lung Ventilators, etc.\n  <\/td><\/tr><tr><td>\n  <strong>D<\/strong>\n  <\/td><td>\n  High\n  <\/td><td>\n  Pacemakers, Heart &amp; Lung Bypass Unit, implants,\n  etc.\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_to_Obtain_CDSCO_Medical_Device_Registration_for_MRI_Machine\"><\/span>Documents Required to Obtain\nCDSCO Medical Device Registration for MRI Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some vital documents required to obtain CDSCO Medical Device Registration for MRI Machine:<\/p>\n\n\n\n<ul><li>Form under the proforma prescribed in the Drugs\nand Cosmetics Rules;<\/li><li>ISO 13485 Certificate;<\/li><li>C.E. Design Certificate;<\/li><li>Legal manufacturer\u2019s name and address with phone\nno. email id;<\/li><li>Full Quality Assurance Certificate;<\/li><li>Actual Site details;<\/li><li>Undertaking that all the details provided are\nauthentic;<\/li><li>Nature of activity (import or export)<\/li><li>Certificate of Marketability through GHTF (the\nUnited States, the European Union, <\/li><\/ul>\n\n\n\n<p>Japan, Australia, Canada)<\/p>\n\n\n\n<ul><li>Band Name (if registered under the Trade Marks\nAct, 1999);<\/li><li>Device Master File;<\/li><li>Free Sale Certificate (FSC) or\/and Certificate\nfrom the Foreign Government;<\/li><li>Plant Master Report.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_to_Obtain_CDSCO_Medical_Device_Registration_for_MRI_Machine\"><\/span>Process to Obtain CDSCO Medical\nDevice Registration for MRI Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Application form will be duly submitted online in\nthe Sugam portal of the Ministry of Health.<\/li><li>Submit required essential documents.<\/li><li>Declaration for compliance with quality\nmanagement system will be duly submitted.<\/li><li>Documents scrutinisation will be done through\nthe LA (Licensing Authority).<\/li><li>If the devices are class B, an inspection will\nbe conducted through the notified body within three months of submitting the\napplication form.<\/li><li>An inspection report will be submitted to\nCLA\/SLA, and a grant of registration certificate will be provided after\nscrutinising the reports.<\/li><li>In the case of the device under classes C &amp;\nD, inspection will be conducted through competent officials. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_Taken_for_CDSCO_Medical_Device_Regulation_for_MRI_Machine\"><\/span>Time Taken for CDSCO Medical\nDevice Regulation for MRI Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It takes around\n6-9 months to register a medical device. Unless an examination is required by\nthe Subject Expert Committee or Technical Presentation, in case these are\nessential, the registration procedure is extended by an additional 3-6 months.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renewal_of_the_CDSCO_Medical_Device_Registration_for_MRI_Machine\"><\/span>Renewal of the CDSCO Medical\nDevice Registration for MRI Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The application form for renewal of <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical device registration<\/a><\/strong><\/a> shall be made at least nine months before the expiry of the CDSCO registration. Since there are no additional requirements for the renewal procedure, it will be vital for the registration certificate holder to provide a copy of the Device Master File (DMF) and Plant Master File (PMF), where there is no change in the DMF &amp; PMF.<\/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>In summary, we can state that CDSCO is consistently working to improve its services&#8217; transparency, accountability, and regularity to guarantee the promptness, safety, potency, and quality of the medical products produced, imported and distributed in India. In conclusion, it is suitable to conclude that CDSCO Registration gives the public interest priority. <\/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-bone-marrow-cell-separator\/\">How to Obtain CDSCO Medical Device Registration for Bone Marrow Cell Separator?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CDSCO (Central Drugs Standard Control Organization) published an order on April 18, 2021, defining all implanted devices, MRI equipment, &amp; other medical devices as drugs, with an April 1 effective date. The importer or manufacturer of such devices is required to obtain an import or production licence from the Central Licensing Authority under Order [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":48001,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2673],"acf":{"service_id":"508"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":4548,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48000"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=48000"}],"version-history":[{"count":9,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48000\/revisions"}],"predecessor-version":[{"id":48011,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48000\/revisions\/48011"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48001"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48000"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48000"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48000"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}