{"id":48181,"date":"2022-09-03T18:10:22","date_gmt":"2022-09-03T12:40:22","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48181"},"modified":"2022-09-03T18:11:56","modified_gmt":"2022-09-03T12:41:56","slug":"cdsco-medical-device-registration-for-organ-preservation-solution","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/","title":{"rendered":"How to Obtain CDSCO Medical Device Registration for Organ Preservation Solution in India?"},"content":{"rendered":"\n<p>In India, the organ preservation market reached a value of 11.7 Million USD in 2021. IMARC Group expects the market to reach 18.5 Million USD by 2027, exhibiting a CAGR of 7.7% from 2022-27.Organ Preservation Solution is the most common cold storage solution in organ preservation. It was first introduced as a preservation solution for pancreas transplantation but has been widely used in preserving the different types of organs, such as kidneys, small bowel and liver, since the last 1980s. Based on the proposal initiated by<em> <\/em>the<strong> Ministry of consumer affairs, food &amp; public distribution<\/strong><sup><a href=\"https:\/\/consumeraffairs.nic.in\/\"><strong>[1]<\/strong><\/a><\/sup><em>,<\/em> to the CLA (Central Licensing authority), CDSCO (Central Drugs Standard Control Organisation), to include many medical devices under the field of the DCGI, Organ Preservative Solution finally needs compulsory registration under the Medical Device Rules 2017 and other standard set by the <strong><a href=\"https:\/\/corpbiz.io\/bis-registration\">BIS (Bureau of Indian Standard) Certification<\/a><\/strong> from time to time. Registration for Organ Preservative Solution under the above rules is compulsory under Class C of Medical Device Rules 2017. This write-up will study how to obtain CDSCO Medical Device Registration for Organ Preservation Solution in India.<\/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-organ-preservation-solution\/#Overview_of_Central_Drugs_Standard_Control_Organisation_CDSCO\" >Overview of Central Drugs\nStandard Control Organisation (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:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/#What_is_Organ_Preservation_Solution\" >What is Organ Preservation\nSolution?<\/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-organ-preservation-solution\/#Notified_Bodies_for_Medical_Devices_in_India\" >Notified Bodies for 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-4\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/#Regulatory_Bodies_for_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\" >Regulatory Bodies for CDSCO\nMedical Device Registration for Organ Preservation Solution<\/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-organ-preservation-solution\/#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-6\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/#Medical_Devices_have_been_classified_as_per_Risk-Based\" >Medical Devices have been\nclassified as per Risk-Based<\/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-organ-preservation-solution\/#Documents_Required_for_Obtaining_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\" >Documents Required for\nObtaining CDSCO Medical Device Registration for Organ Preservation Solution<\/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-organ-preservation-solution\/#Procedure_to_Obtain_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\" >Procedure to Obtain CDSCO\nMedical Device Registration for Organ Preservation Solution<\/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-organ-preservation-solution\/#Time_taken_for_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\" >Time taken for CDSCO Medical\nDevice Registration for Organ Preservation Solution<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/#Renewal_of_the_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\" >Renewal of the CDSCO Medical\nDevice Registration for Organ Preservation Solution<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-organ-preservation-solution\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Central_Drugs_Standard_Control_Organisation_CDSCO\"><\/span>Overview of Central Drugs\nStandard Control Organisation (CDSCO)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central\nDrugs Standard Control Organisation, also known as CDSCO, under the Directorate\nGeneral of Health Services, Ministry of Health &amp; Family Welfare, and Indian\nGovernment, is India&#8217;s National Regulatory Authority (NRA). Under the Drugs\n&amp; Cosmetics Act, CDSCO has various responsibilities that include approval\nof Drugs to direct Clinical Trials, a quality check of imported Drugs in India,\nproviding standards for Drugs and coordinating with the State Drugs Control\nOrganisations for the activities by providing expert advice, training keeping\nin knowledge the uniformity in the implementation of the Drug &amp; Cosmetics\nAct. Moreover, CDSCO and State Drugs Control Organisations are together\nanswerable for permit of licenses of certain specialized kinds of critical\ndrugs and medical devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Organ_Preservation_Solution\"><\/span>What is Organ Preservation\nSolution?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Organ Preservation\nrefers to maintaining the viability of healthy organs harvested from the donor\nbody to transplant them into the receiver body. This procedure involves\nremoving, storing &amp; transporting the organ in SCS (Static Cold Storage),\nwhich prevents harmful metabolites from breaking down healthy tissues, thereby\nenhancing the ability to restore normal organ functionality\npost-transplantation. It also employs several other techniques, like\nhypothermic machine perfusion and NMP (Normothermic Machine Perfusion), to\nmaintain the oxygen level &amp; temperature of the organs. Organ preservation\nalso utilizes special solutions important in sustaining donor organ quality. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Notified_Bodies_for_Medical_Devices_in_India\"><\/span>Notified Bodies for Medical\nDevices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li><strong>Central Licensing Authority (CLA):<\/strong> It\nis entrusted to provide a license to every imported medical device in India,\nincluding providing manufacturing, wholesale and loan license to medical\ndevices under Class C &amp; D. additionally, CLA might provide services of a\nnotified body to inspect the manufacturing premises, location and technical\nreview of medical devices under Classes C &amp;D.<\/li><li><strong>State Licensing Authority (SLA):<\/strong> It has\nbeen entrusted with the liability of providing manufacturing, wholesale, and\nloan license to medical devices under Class A &amp; B. SLA also assigns a\nnotified body to validate the QMS (Quality Management System) requirements\n&amp; technical review of medical devices under Class A &amp; B manufacturers.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Bodies_for_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\"><\/span>Regulatory Bodies for CDSCO\nMedical Device Registration for Organ Preservation Solution<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li><strong>CDSCO<\/strong> is the head regulatory body under\nthe Directorate General of Health Services and Ministry of Health and Family\nWelfare that regulates drugs and medical devices.<\/li><li><strong>DCGI<\/strong> is the head of the CDSCO, and it\nis answerable for approving quality drugs, medical devices and cosmetics to be\nsold to Indian customers and regulating clinical trials.<\/li><li><strong>The Drug &amp; Cosmetics Act and Rules<\/strong>\nregulate the manufacture, import, distribution and sale of Drugs and medical\ndevices in India.<\/li><\/ol>\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>The Medical Devices under CDSCO have been classified into two types, as given below:<\/p>\n\n\n\n<ul><li><strong>Non-Notified Medical Devices<\/strong><\/li><\/ul>\n\n\n\n<ol><li>Non-notified medical devices include 313 medical items that must be CDSCO Certified.<\/li><li>According to the new amendment issued from the CDSCO, medical devices like instruments, implants and apparatus, irrespective of their usage for a distinct objective, will fall under non-notified medical devices.<\/li><\/ol>\n\n\n\n<ul><li><strong>Notified Medical Devices<\/strong><\/li><\/ul>\n\n\n\n<ol><li>Notified medical devices comprise 37 items which need to be CDSCO certified.<\/li><li>According to Rule 4 of medical devices rule 2017, notified medical devices are those whose registration is compulsory.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Devices_have_been_classified_as_per_Risk-Based\"><\/span>Medical Devices have been\nclassified as per Risk-Based <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong><em>Risk-Based<\/em><\/strong>\n  <\/td><td>\n  <strong><em>Class <\/em><\/strong>\n  <\/td><td>\n  <strong><em>Examples of Medical Device<\/em><\/strong>\n  <\/td><\/tr><tr><td>\n  <strong><em>Low <\/em><\/strong>\n  <\/td><td>\n  <strong><em>A<\/em><\/strong>\n  <\/td><td>\n  Surgical dressing, Syringes, etc.\n  <\/td><\/tr><tr><td>\n  <strong><em>Moderate Low<\/em><\/strong>\n  <\/td><td>\n  <strong><em>B<\/em><\/strong>\n  <\/td><td>\n  Pregnancy Kits, Surgical Gloves, etc.\n  <\/td><\/tr><tr><td>\n  <strong><em>Moderate High<\/em><\/strong>\n  <\/td><td>\n  <strong><em>C<\/em><\/strong>\n  <\/td><td>\n  Anaesthesia, Lung Ventilators, etc.\n  <\/td><\/tr><tr><td>\n  <strong><em>High <\/em><\/strong>\n  <\/td><td>\n  <strong><em>D<\/em><\/strong>\n  <\/td><td>\n  Heart &amp; Lung Bypass Unit, Pacemakers, 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_for_Obtaining_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\"><\/span>Documents Required for\nObtaining CDSCO Medical Device Registration for Organ Preservation Solution<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some essential documents to obtain CDSCO Medical Device Registration for Organ Preservation Solution:<\/p>\n\n\n\n<ul><li>Form under the proforma prescribed in the Drugs &amp; Cosmetics Rules;<\/li><li>ISO 13485 Certificate;<\/li><li>Legal manufacturer\u2019s name &amp; address along with phone no. and email id;<\/li><li>C.E. Design Certificate;<\/li><li>Actual Site information;<\/li><li>Full Quality Assurance Certificate;<\/li><li>Nature of activity (import\/export)<\/li><li>Undertaking that all the information provided is authentic;<\/li><li>Brand Name (if registered under the Trade Marks Act, 1999);<\/li><li>Certificate of Marketability from the GHTF (the European Union, the United States,<\/li><\/ul>\n\n\n\n<p>Japan, Australia, Canada)<\/p>\n\n\n\n<ul><li>Free Sale Certificate (FSC) and\/or Certificate\nby the Foreign Government;<\/li><li>Device Master File;<\/li><li>Plant Master File.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\"><\/span>Procedure to Obtain CDSCO\nMedical Device Registration for Organ Preservation Solution<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the process for getting CDSCO Medical Device Registration for Organ Preservation Solution in India:<\/p>\n\n\n\n<ul><li>An application form will be duly submitted\nonline along with the necessary documents in the CDSCO Sugam portal of the\nMinistry of Health.<\/li><li>Declaration for compliance along with quality\nmanagement system will be correctly submitted.<\/li><li>Documents scrutinization will be done by the\nL.A. (Licensing Authority).<\/li><li>In case the devices are class B, the notified\nbody will inspect them within three months of submitting the application form.<\/li><li>An inspection report will be submitted to\nCLA\/SLA, and a grant of medical device registration certificate will be\nprovided after examining the reports.<\/li><li>If the device is under classes C &amp; D, an\ninspection will be conducted by authorized officials. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_taken_for_CDSCO_Medical_Device_Registration_for_Organ_Preservation_Solution\"><\/span>Time taken for CDSCO Medical\nDevice Registration for Organ Preservation Solution<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It takes almost\nthree months to register a medical device for domestic manufacturers and 6 to 9\nmonths for a foreign manufacturer. Unless an examination is required by the\nTechnical Presentation or Subject Expert Committee, if these are necessary, the\nmedical device registration process is extended to an additional 3 to 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_Organ_Preservation_Solution\"><\/span>Renewal of the CDSCO Medical\nDevice Registration for Organ Preservation Solution <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The application\nform for renewal of CDSCO Medical Device Registration for Organ Preservation\nSolution shall be made at least 9 months before the registration expiry. Since\nthere are no additional requirements for the renewal process, it will be\nessential for the medical device registration certificate holder to provide a\ncopy of the Plant Master File (PMF) &amp; Device Master File (DMF), where there\nis no change in the PMF and DMF.<\/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> One of the main factors propelling the growth of the organ preservation market in India is the increasing number of organ failures brought on by the rising incidence of different chronic conditions, such as obesity, cardiovascular disease, and gastrointestinal disorders. The growth of the market in the nation is also being supported by the expansion of the medical industry and an increase in per capita spending on healthcare services. Additionally, the Government of India (GoI) promotes organ donation through initiatives, another element that stimulates growth.  <\/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-nebuliser\/\">CDSCO Medical Device Registration for Nebuliser<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, the organ preservation market reached a value of 11.7 Million USD in 2021. IMARC Group expects the market to reach 18.5 Million USD by 2027, exhibiting a CAGR of 7.7% from 2022-27.Organ Preservation Solution is the most common cold storage solution in organ preservation. It was first introduced as a preservation solution for [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":48182,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2689],"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":2946,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48181"}],"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=48181"}],"version-history":[{"count":9,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48181\/revisions"}],"predecessor-version":[{"id":48192,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48181\/revisions\/48192"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48182"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48181"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48181"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48181"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}