{"id":47176,"date":"2022-08-23T12:12:00","date_gmt":"2022-08-23T06:42:00","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47176"},"modified":"2022-08-23T12:12:02","modified_gmt":"2022-08-23T06:42:02","slug":"top-differences-between-medical-devices-and-ivds","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/top-differences-between-medical-devices-and-ivds\/","title":{"rendered":"Top Differences Between Medical Devices and IVDs"},"content":{"rendered":"\n<p>Medical devices and IVDs are regulated &amp; controlled by the Drug Controller General of India, also known as DCGI, which operates under the <strong>Central Drugs Standard Control Organization (CDSCO)<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Central_Drugs_Standard_Control_Organisation\"><strong>[1]<\/strong><\/a><\/sup>. CDSCO is a part of the Ministry of Health and Family Welfare. The rules and Regulations of Medical devices are based on Medical Device Rules, 2017. Not all Medical Devices and IVDs are required to be registered in India; there is a limited list of Medical devices and IVDs that are to be essentially registered 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\/top-differences-between-medical-devices-and-ivds\/#In-Vitro_Diagnostics_%E2%80%93_Meaning\" >In-Vitro Diagnostics &#8211; Meaning<\/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\/top-differences-between-medical-devices-and-ivds\/#Medical_Devices_%E2%80%93_Meaning\" >Medical Devices &#8211; Meaning<\/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\/top-differences-between-medical-devices-and-ivds\/#CLA_and_SLA_Regulations_in_Medical_Devices_and_IVD\" >CLA and SLA Regulations in\nMedical Devices and IVD<\/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\/top-differences-between-medical-devices-and-ivds\/#Difference_between_Medical_devices_and_IVD\" >Difference between Medical\ndevices and IVD<\/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\/top-differences-between-medical-devices-and-ivds\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"In-Vitro_Diagnostics_%E2%80%93_Meaning\"><\/span>In-Vitro Diagnostics &#8211; Meaning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In-Vitro\nDiagnostics or IVDs are medical devices and tools used for the purpose of\ntesting samples like blood, urine, and tissues which are taken from the human\nbody in order to detect infections or a medical condition, or to prevent any\ndisease, etc.<\/p>\n\n\n\n<p>IVDs are the\ntools used outside the human Body to find out any abnormality, disease or\ndisorder. The list of IVDs is mentioned in section 3(b) (i) of the Drugs and\nthe Cosmetics Acts, 1940. Section 3 (b) (iv) of The Drugs &amp; Cosmetics Acts,\n1940 covers the IVDs that are notified from time to time. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Devices_%E2%80%93_Meaning\"><\/span>Medical Devices &#8211; Meaning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical devices\nare the tools, articles or materials which are made to be used on human beings\nfor the purpose of prevention, diagnosis, monitoring, and treatment of diseases\nor any Injury or physical disorder. These are also used for the process of\ninvestigation, replacement or modification of anatomical or physiological\nprocess for the purpose of controlling any conception that does not meets its\ngoals through pharmacological, immunological or metabolic means.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\n&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CLA_and_SLA_Regulations_in_Medical_Devices_and_IVD\"><\/span>CLA and SLA Regulations in\nMedical Devices and IVD<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drug Standard Control Organization <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>(CDSCO)<\/strong><\/a> authorizes Central Licensing Authority (CLA) and State Licensing Authority (SLA) in order to maintain laws and regulations on the Import, export, Licensing, registration, manufacture, marketing etc. of Drugs, Medical Devices and IVDs. <\/p>\n\n\n\n<ul><li><strong>CLA:<\/strong><\/li><\/ul>\n\n\n\n<p>CLA is the Body\nthat is responsible for the regulation of Import device licensing and\nmanufacturing of Class C&amp; D Medical Devices. CLA may also avail services of\na notified body for the purpose of inspection of the manufacturing site of\nClass C and Class D medical devices. CLA is also responsible for regulating\nrules and procedures for IVDs. It regulated Imports of all classes of IVDs,\nalong with the manufacture of Class C and Class D IVDs. CLA is responsible for\nthe registration of Notified Medical devices and IVDs. It also approves new\nIVDs and evaluates their clinical performance and quality check-up. CLA grants\nregistration of labs for performing the tests and regular evaluation. It also\ngrants licenses for the purpose of manufacturing or importing all classes of\nIVDs. <\/p>\n\n\n\n<ul><li><strong>SLA:<\/strong><\/li><\/ul>\n\n\n\n<p>The State\nLicensing Authority (SLA) is responsible for granting licenses for\nmanufacturing, loans and wholesale of Class A &amp; Class B Medical Devices.\nSLA authorizes a Notified Body to inspect the Quality Management System and\nTechnical Review for manufacturers of Class A &amp; B Medical Device. SLA makes\nand maintains rules and regulations for the purpose of manufacturing Medical\nDevices and for the sale or distribution of Class A or Class B IVD. It\nregulates the process of selling IVDs of all classes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Difference_between_Medical_devices_and_IVD\"><\/span>Difference between Medical\ndevices and IVD<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>Medical\nDevices:<\/strong><\/li><\/ul>\n\n\n\n<p>&#8220;A Medical\nDevice can be considered as any instrument, tool, apparatus, implement, machine,\nappliance, implant, and reagent for the purpose of in vitro use, software,\nmaterial or any other related article, intended by the manufacturer to be used,\nalone or in combination for a medical purpose.&#8221;<\/p>\n\n\n\n<p>Earlier, there\nwas no jurisdiction in the selling of Medical Devices by the manufacturers.\nThey used to sell medical devices without any rule or law governing them.\nLater, as a policy of the FDA, Indian Medical Device Regulations were made by\nCDSCO, which made it necessary for the Import or Export of Medical Devices in\nIndia to be regulated. In India, only the notified medical devices need to be\nregulated by CDSCO. The registration certificate comes as Form-41, and the\nImport License comes as Form-10 as per the rules of the Drugs and Cosmetics\nActs, 1940. There are 37 categories of devices that need to be regulated by\nCDSCO before being Imported, Exported or Sold in India. A different set of\nsupporting documents is needed with every application form submitted to the\nCDSCO. <\/p>\n\n\n\n<p><strong>Time period and Validity of Registration of\nMedical Devices-<\/strong><\/p>\n\n\n\n<p>In India, after\nthe manufacturer has completed submitting all the relevant documents and the\nregistration\/ license fees, the time period for the registration of Medical\nDevices is usually 6 to 9 months. The registration remains valid for three\nyears. For the purpose of re-registration in case of expiry of the registration\ncertificate, the renewal application for the registration should be submitted\nsix months before the expiry. <\/p>\n\n\n\n<ul><li><strong>In vitro\ndiagnostics (IVDs):<\/strong><\/li><\/ul>\n\n\n\n<p>In vitro diagnostics (IVDs) are the devices that are\nused to detect diseases, infections and testing samples like blood, urine, and\ntissues which are taken from the human Body in order to detect infections or a\nmedical condition, or to prevent any disease, etc. In- Vitro means &#8220;In\nGlass&#8221;, which means the tests are conducted in test tubes and similar\nglass equipment, whereas In-Vivo tests are conducted in the Body Itself. <\/p>\n\n\n\n<p>IVD kits are divided into two types- Notified and\nNon-Notified IVDs. IVD kits\/reagents are classified into two categories as\nNotified and Non-notified IVD products.<\/p>\n\n\n\n<p><strong><em>The\nNotified products are-<\/em><\/strong><\/p>\n\n\n\n<ul><li>In-Vitro Diagnostic Devices for HIV<\/li><li>In-Vitro Diagnostic Devices for HBV<\/li><li>In-Vitro Diagnostic Devices for HCV<\/li><li>In-Vitro Blood grouping sera<\/li><\/ul>\n\n\n\n<p>For the purpose\nof registration of In Vitro Diagnostic Kits in India, Form-41 is required for\nthe registration certificate of notified IVDs and Form-10 is required for the\nNon-Notified IVDs, as regulated by the Drugs and Cosmetics Rules. A Test\nLicense via Form-11 and the Performance Evaluation report is needed before the\nregistration application of IVD products.<\/p>\n\n\n\n<p><strong>Time period and Validity of Registration of\nIVD:<\/strong><\/p>\n\n\n\n<p>In India, the\nvalidity of Form-11 for the purpose of test license is for one year unless the\nlicense is suspended or cancelled, whereas the Registration certificate OD IVDs\nis valid for three years.<\/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 Indian market has been a huge attraction to the manufacturers of medical devices and IVDs. But there are challenges ahead for the regulatory Body in India, as it is at its Initial stage and the regulations and rules need to be amended and improved over time. <\/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\/medical-device-and-ivd-emergency-in-india\/\">Medical Device and IVD Emergency in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical devices and IVDs are regulated &amp; controlled by the Drug Controller General of India, also known as DCGI, which operates under the Central Drugs Standard Control Organization (CDSCO)[1]. CDSCO is a part of the Ministry of Health and Family Welfare. The rules and Regulations of Medical devices are based on Medical Device Rules, 2017. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47177,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2627],"acf":{"service_id":"508"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":4725,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47176"}],"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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=47176"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47176\/revisions"}],"predecessor-version":[{"id":47192,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47176\/revisions\/47192"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47177"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}