{"id":48462,"date":"2022-09-09T10:44:13","date_gmt":"2022-09-09T05:14:13","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48462"},"modified":"2022-09-09T10:44:15","modified_gmt":"2022-09-09T05:14:15","slug":"parameters-for-classification-of-ivd-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/parameters-for-classification-of-ivd-medical-devices\/","title":{"rendered":"Parameters for Classification of IVD Medical Devices"},"content":{"rendered":"\n<p>CDSCO manages the affairs relating to the classification of IVD medical devices. The same department operates under the purview of the Drug Controller General of India. The Drugs &amp; Cosmetics Act &amp; Rule, 1949 &amp; 1945 constitute the regulatory framework for each medical device in India. The Health Ministry of India has released the new IVD medical devices regulation to improve the effectiveness of the <strong>Drugs &amp; Cosmetics Act 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup>. In this write-up, we will discuss the classification of IVD Medical Devices.<\/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\/parameters-for-classification-of-ivd-medical-devices\/#Overview_of_the_New_Medical_Devices_Rules_India_2017\" >Overview of the New Medical\nDevices Rules India, 2017<\/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\/parameters-for-classification-of-ivd-medical-devices\/#What_are_the_In-Vitro_Diagnostic_IVD_Medical_Devices\" >What are the In-Vitro\nDiagnostic (IVD) Medical Devices?<\/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\/parameters-for-classification-of-ivd-medical-devices\/#Classification_of_IVD_Medical_Devices\" >Classification of IVD 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\/parameters-for-classification-of-ivd-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_the_New_Medical_Devices_Rules_India_2017\"><\/span>Overview of the New Medical\nDevices Rules India, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The new rules mitigate the requirement of periodic renewal of licenses. Accordingly, the production and import licenses shall continue to stay valid till these are suspended or revoked or surrendered. The entire licensing process shall be executed online via a dedicated online portal known as SUGAM. The said portal shall ensure seamless submission, tracking, and review of the registration documents. Regulators have already briefed out about the timeline of all the activities concerned. The Sugam portal shall also provide the facility for change in granted registration. The applicant can access this facility via \u201cPost Approval Change\u201d.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_In-Vitro_Diagnostic_IVD_Medical_Devices\"><\/span>What are the In-Vitro\nDiagnostic (IVD) Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In- Vitro Diagnostic\n(IVD) medical devices are instruments, reagents and systems intended to\ndiagnose a disease or other conditions, including to cure, determine the state\nof health, mitigate, treat, or prevent disease or its sequelae. These devices\nare intended for the preparation, collection and examination of specimens taken\nby the human body.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_IVD_Medical_Devices\"><\/span>Classification of IVD Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Under the new\nmedical device rules, 2016 IVD (In-Vitro diagnostics) are categorized into four\nclasses, ranging from Classes A to D, classified based on parameters described\nin the official Gazette released on October 17, 2016.<\/p>\n\n\n\n<ul><li><strong><em>Class A: Low Risk;<\/em><\/strong><\/li><li><strong><em>Class B: Moderate Risk;<\/em><\/strong><\/li><li><strong><em>Class C: Moderate High Risk;<\/em><\/strong><\/li><li><strong><em>Class D: High Risk.<\/em><\/strong><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class-A\nClassification of IVD Medical Devices<\/strong><\/h3>\n\n\n\n<p>In-Vitro Diagnostic medical devices used in IVD procedures shall be assigned to Class A in case it is intended to be used as:<\/p>\n\n\n\n<ul><li>A substance or an object possesses any specific\ncharacteristic its object owner intends to make suitable for an IVDs procedure\nrelated to a certain examination.<\/li><li>A device specifically to be used for an IVD\nprocedure or a variety of containers.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class-B\nClassification of IVD Medical Devices<\/strong><\/h3>\n\n\n\n<p>An IVDs medical device shall be assigned to Class B in case it is intended for use in:<\/p>\n\n\n\n<ul><li>IVD medical devices for self-testing referred to\nin sub-clause (a) shall be assigned to Class B and intended to be used to get\ntest results which are not for the determination of a medically critical status\nand preliminary test results that needs confirmation through the appropriate\nlaboratory tests.<\/li><li>Other IVD medical devices shall be assigned to\nClass B in case clauses 2(i) to 2(v) don&#8217;t apply to it or a substance or\nproduct used for the analysis of the performance of an analytical process or a\npart thereof without a qualitative or quantitative assigned value.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class-C\nClassification of IVD Medical Devices<\/strong><\/h3>\n\n\n\n<p>An IVDs medical device shall be assigned to Class C in case it is intended for use in:<\/p>\n\n\n\n<ul><li>Detecting the exposure to or presence of a\nsexually transmitted disease.<\/li><li>Detecting the presence in cerebrospinal\nfluid\/blood of an infection agent with a risk of propagation.<\/li><li>Pre-natal screening of women to determine their\nimmune system status towards transmissible agents.<\/li><li>Detecting the presence of an infectious agent,\nwhere there is a significant risk that an incorrect result will cause death\/\nsevere disability to the individual or foetus being tested.<\/li><li>Determining infective disease status or immune\nsystem status, where there is a risk that an erroneous result will lead to a\npatient&#8217;s management decision resulting in an imminent life-threatening\nsituation for the patient being tested.<\/li><li>Testing of human genetics.<\/li><li>Screening for disease staging for selecting\npatients for selective therapy &amp; management or in the diagnostic testing.<\/li><li>Monitoring levels of medicinal items, biological\nor substance components, where there is a risk that an erroneous result will\nlead to a patient.<\/li><li>Management decisions result in an immediate\nlife-threatening situation for the patient being tested.<\/li><li>Screening for congenital disorders in the\nfoetus.<\/li><li>Management of patients suffering from\nlife-threatening infectious diseases.<\/li><li>Blood grouping\/tissue typing is subject to\nsub-clause (b) in case it is intended to be used for blood grouping or tissue\ntyping or to ensure that immunological compatibility of any blood &amp; blood\ncomponent, cell, tissue, blood derivative or organ which is intended for\ntransplantation or transfusion.<\/li><li>Testing of near-patient in case it is to be used\nfor near-patient in a blood gas analysis or a blood glucose determination.<\/li><li>Self-testing devices are subject to sub-clause\n(b). <\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class\nD Classification of IVS Medical Devices<\/strong><\/h3>\n\n\n\n<p>IVD medical device for detecting transmissible agents shall be assigned to Class D in case it is intended to be used:<\/p>\n\n\n\n<ul><li>For detecting the exposure to, or presence of, a\ntransmissible agent;<\/li><li>In any blood, blood component, cell, tissue,\nblood derivative or organ, as the case may be, for transplantation or\ntransfusion or causes a life-threatening disease with a high risk of\npropagation.<\/li><\/ul>\n\n\n\n<p><strong><em>Note:\nIVD medical devices for blood grouping or tissue typing referred to in\nsub-clause (a) shall be assigned to Class D in case it is intended to be used\nfor blood grouping or tissue typing as per the ABO system, the Duffy system,\nthe Kidd system, the rhesus system.<\/em><\/strong><\/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 New Classification system from the <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> (Central Drugs Standard Control Organization) is a forward step toward commercialization &amp; registration of IVD (In-Vitro Diagnostics) as the Indian market of IVD is expected growth to cross billion dollars soon in India.<\/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\/top-differences-between-medical-devices-and-ivds\/\">Top Differences Between Medical Devices and IVDs<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO manages the affairs relating to the classification of IVD medical devices. The same department operates under the purview of the Drug Controller General of India. The Drugs &amp; Cosmetics Act &amp; Rule, 1949 &amp; 1945 constitute the regulatory framework for each medical device in India. The Health Ministry of India has released the new [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":48463,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2706],"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":3066,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48462"}],"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=48462"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48462\/revisions"}],"predecessor-version":[{"id":48478,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48462\/revisions\/48478"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48463"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48462"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48462"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}