{"id":46166,"date":"2022-08-05T11:12:14","date_gmt":"2022-08-05T05:42:14","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46166"},"modified":"2024-02-05T17:46:41","modified_gmt":"2024-02-05T12:16:41","slug":"different-classes-of-medical-device-their-risk-levels","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/different-classes-of-medical-device-their-risk-levels\/","title":{"rendered":"Different Classes of Medical Device &#038; their Risk Levels &#8211; An Overview"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Central Drugs Standard Control Organization (CDSCO) is\nIndia&#8217;s national body for regulating medical devices and drugs. It performs\nduties comparable to those of the European Medicines Agency, Food and Drug\nAdministration of the U. S., and the treatments and health services products\nRegulatory Agency of the United Kingdom. According to the Indian regulatory\nbody, it is medical to have a CDSCO licence in order to sell different classes\nof medical devices. Each country has its own dedicated overseeing body under\nthe ministry of health to make sure that all pharmaceuticals and medical\ndevices are safe and effective. The CDSCO is in charge of regulating the\nregistration and sale of medical devices that have been approved for use in\nIndia.<\/p>\n\n\n\n<p>Under the DCGI, the regulatory approval and registration of <strong><a href=\"https:\/\/corpbiz.io\/learning\/import-and-export-of-medical-devices\/\">medical devices<\/a><\/strong> by the CDSCO are governed by the different classes of medical devices set out by the CDSCO. The <strong><a href=\"https:\/\/corpbiz.io\/learning\/penalties-under-drugs-and-cosmetics-act-1940\/\">Drugs and Cosmetics Act<\/a><\/strong> of India needs to be updated, so the Health Ministry of India sent out new guidelines for medical devices and IVDs. Also, the CDSCO and state regulators are both in charge of giving licences for certain classes of basic medications, such as blood and blood products, I.V. liquids, vaccines, and sera. <\/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\/different-classes-of-medical-device-their-risk-levels\/#Different_Classes_of_Medical_Device_their_Risk-based_Classifications_by_CDSCO\" >Different Classes of Medical Device &amp; their Risk-based\nClassifications by 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\/different-classes-of-medical-device-their-risk-levels\/#Risk_Based_Factors\" >Risk Based Factors<\/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\/different-classes-of-medical-device-their-risk-levels\/#Indian_Medical_Devices_Classification_%E2%80%93_Different_Classes_of_Medical_Device\" >Indian Medical Devices\nClassification &#8211; Different Classes of Medical Device<\/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\/different-classes-of-medical-device-their-risk-levels\/#Aim_of_CDSCO_Registration\" >Aim&nbsp;of CDSCO Registration<\/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\/different-classes-of-medical-device-their-risk-levels\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_Classes_of_Medical_Device_their_Risk-based_Classifications_by_CDSCO\"><\/span>Different Classes of Medical Device &amp; their Risk-based\nClassifications by CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Indian regulators of the medical devices market have sent out another draught list of the Different Classes of Medical Devices. This list shows how the Medical Devices Rules of 2017 classify these devices. India is thought to be one of the best places to sell medical devices because it imports a lot of them. Classifications of Different Classes of Medical Device by CDSCO, led by the <strong>Drug Controller General of India (DCGI)<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_Controller_General_of_India\"><strong>[1]<\/strong><\/a><\/sup>, is in charge of regulating Different Classes of Medical Devices in the country. The law divides different classes of medical devices into four types: A, B, C, and D. Based on how dangerous they are, medical devices are put into one of four groups. To get a CDSCO manufacturing licence, companies that make medical devices need to register with CDSCO. The manufacturer needs help figuring out what paperwork they need to fill out for the <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO registration<\/strong><\/a> process.<\/p>\n\n\n\n<table class=\"table table-bordered\">\n<thead>\n<tr>\n<td width=\"66\">\n<p>Type of Device<\/p>\n<\/td>\n<td width=\"103\">\n<p>Risk<\/p>\n<\/td>\n<td width=\"70\">\n<p>Device Class<\/p>\n<\/td>\n<td width=\"109\">\n<p>QMS Audit<\/p>\n<\/td>\n<td width=\"118\">\n<p>Regulatory Pathway<\/p>\n<\/td>\n<td width=\"47\">\n<p>IAA<\/p>\n<\/td>\n<td width=\"128\">\n<p>Final Outcome<\/p>\n<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"66\">\n<p>Non-Notified Device<\/p>\n<\/td>\n<td width=\"103\">\n<p>NA<\/p>\n<\/td>\n<td width=\"70\">\n<p>NA<\/p>\n<\/td>\n<td width=\"109\">\n<p>NA<\/p>\n<\/td>\n<td width=\"118\">\n<p>Listing of devices in SUGAM portal<\/p>\n<\/td>\n<td width=\"47\">\n<p>Yes<\/p>\n<\/td>\n<td width=\"128\">\n<p>Listing in database<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td rowspan=\"4\" width=\"66\">\n<p>Notified Device<\/p>\n<\/td>\n<td width=\"103\">\n<p>Low Risk<\/p>\n<\/td>\n<td width=\"70\">\n<p>A<\/p>\n<\/td>\n<td rowspan=\"4\" width=\"109\">\n<p>Schedule 5 of MDR 2017 or<\/p>\n<p>ISO 13485:2016 certification<\/p>\n<\/td>\n<td rowspan=\"4\" width=\"118\">\n<p>Device Registration<\/p>\n<\/td>\n<td rowspan=\"4\" width=\"47\">\n<p>Yes<\/p>\n<\/td>\n<td rowspan=\"4\" width=\"128\">\n<p>Test \/ Manufacturing \/Loan\/Import License<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"103\">\n<p>Low &#8211; Moderate Risk<\/p>\n<\/td>\n<td width=\"70\">\n<p>B<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"103\">\n<p>Moderate &ndash; High Risk<\/p>\n<\/td>\n<td width=\"70\">\n<p>C<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"103\">\n<p>High Risk<\/p>\n<\/td>\n<td width=\"70\">\n<p>D<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk_Based_Factors\"><\/span>Risk Based Factors<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Most medical devices are classified by the risks they pose. How a\nmedical device is actually classified by its risks depends on how and why it is\nused. CDSCO&#8217;s Different Classes of Medical Device classifies a larger group of\ndevices, like cannulas and stents, into smaller groups with more specific\nnames.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indian_Medical_Devices_Classification_%E2%80%93_Different_Classes_of_Medical_Device\"><\/span>Indian Medical Devices\nClassification &#8211; Different Classes of Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, there are different classification systems for IVD and medical\ndevices, and each of these systems has four classes based on how dangerous the\ndevices are. In the table below, there are&nbsp;4 different types of Indian\nmedical devices:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Device Class<\/strong>\n  <\/td><td>\n  <strong>Risk<\/strong>\n  <\/td><\/tr><tr><td>\n  A\n  <\/td><td>\n  Low Risk\n  <\/td><\/tr><tr><td>\n  B\n  <\/td><td>\n  Low Moderate Risk\n  <\/td><\/tr><tr><td>\n  C\n  <\/td><td>\n  Moderate-High Risk\n  <\/td><\/tr><tr><td>\n  D\n  <\/td><td>\n  High Risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><strong><a href=\"https:\/\/corpbiz.io\/learning\/classification-of-medical-devices-by-cdsco\/\">Different Classes of Medical Devices<\/a><\/strong> have been divided into four different categories in accordance with the New Medical Rules of 2017. Class A, B, C and D. Any company that aims to manufacture such devices for distribution or sale must submit an application to CDSCO for a manufacturer&#8217;s licence.<\/p>\n\n\n\n<p>Both class A and B medical devices are considered to be\nof&nbsp;low- and moderate-risk. The State Licensing Authority must receive the\napplication for manufacturing these classes of medical devices (SLA). Class C\nand Class D devices are identified as High and Extremely High Risk devices,\nrespectively. The application for their production must be submitted to the\nCentral Licensing Authority (CLA).<\/p>\n\n\n\n<p><strong><em>IVD medical devices will be divided into four categories based on how\nthey are used and how dangerous they are (New Medical Device Rules 2018).<\/em><\/strong><\/p>\n\n\n\n<p>The new devices establish a risk-based approach in which the\nlevel of regulation varies considerably based on the risks &amp; technology\nassociated with the meant use and characteristics of the device. Under the new\nsystem, four classes (Class A, B, C, and D) have been established, with Class A\nand B devices posing the lowest risk to patients and Class C and D devices\nposing the highest risk.<\/p>\n\n\n\n<p>For example, a Class A device would be an elastic bandage or\na mechanical barrier used to apply pressure or take in exudates from wounds\nthat haven&#8217;t broken through the dermis and can heal on their own. Contact lens\npoints are an example of a Class B medical device, whereas a blood bag that\ndoes not contain a drug would be considered a Class C device. Lastly, a transient-use,\nsurgically invasive medical device that is anticipated to be used explicitly in\ndirect contact with the central nervous system or for the diagnosis,\nmonitoring, or correction of a heart problem or central circulatory framework\ncondition via direct contact with body parts would be a Class D device.<\/p>\n\n\n\n<p>These risk classifications will allow Indian medical device\nmarket registrants and their in-country members to better consider issues such\nas cost, clinical data requirements, and import authorization authority when\nmarketing their products in India. The new regulation will harmonise the use of\nmedical device devices with International Standards to facilitate the\nmanufacturing and importation of medical devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Aim_of_CDSCO_Registration\"><\/span>Aim&nbsp;of CDSCO Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>Approval of new medications and clinical studies.<\/li>\n\n\n\n<li>Import permits.<\/li>\n\n\n\n<li>Licensing for making medical devices.<\/li>\n\n\n\n<li>Blood bank, vaccine, and medical device licencing<\/li>\n\n\n\n<li>Amendments to the Drugs &amp; Cosmetics Act and its implementing regulations.<\/li>\n\n\n\n<li>Compliance with WHO GMP certification schemes.<\/li>\n\n\n\n<li>Grant to test licence, personal licence, <strong><a href=\"https:\/\/corpbiz.io\/drug-export-noc\">NOCs for export<\/a><\/strong>.<\/li>\n\n\n\n<li>Central lab testing of drugs<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the medical field, there is always a balance between risks and benefits. In the medical device industry, the class of a medical device is used to classify how risky a device is and, consequently, what level of risk reduction is required. In terms of risk mitigation, a simple item like a&nbsp;bandage does not require much, whereas a complex medical device like a complex surgical laser would require significantly more.<\/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\/registration-process-for-medical-devices-in-india\/\">A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drugs Standard Control Organization (CDSCO) is India&#8217;s national body for regulating medical devices and drugs. It performs duties comparable to those of the European Medicines Agency, Food and Drug Administration of the U. S., and the treatments and health services products Regulatory Agency of the United Kingdom. According to the Indian regulatory body, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46171,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2565],"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":8840,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46166"}],"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=46166"}],"version-history":[{"count":19,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46166\/revisions"}],"predecessor-version":[{"id":61938,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46166\/revisions\/61938"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46171"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46166"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46166"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46166"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}