{"id":29363,"date":"2021-04-25T10:30:35","date_gmt":"2021-04-25T05:00:35","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=29363"},"modified":"2022-05-20T12:41:08","modified_gmt":"2022-05-20T07:11:08","slug":"medical-device-and-ivd-emergency-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/medical-device-and-ivd-emergency-in-india\/","title":{"rendered":"Medical Device and IVD Emergency in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The regulation of Medical devices and In vitro diagnostic device (IVDs) in India are managed by the Drug Controller General of India (DCGI) which is within the Central Drugs Standard Control Organization (CDSCO). The regulatory structure for medical devices and In vitro diagnostic device (IVDs) is established on drug regulations under the&nbsp;<em><strong>Drugs and Cosmetics Act,&nbsp;1940<\/strong><\/em><strong>and&nbsp;<\/strong><em><strong>Rules of the Drugs and Cosmetics 1945&nbsp;<\/strong><\/em><strong>(D&amp;C Rules), in addition to the&nbsp;<\/strong><em><strong>Medical Device Rules, 2017&nbsp;<\/strong><\/em><strong>(MDR-17)<\/strong>.<\/p>\n\n\n\n<p>The importance of <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical devices<\/strong><\/a> is becoming more significant in the sector of medicine and health care. In vitro diagnostic devices are medical devices used in-vitro for conducting tests on samples like blood, urine, diagnosing a medical condition, body tissues taken to detect infections from the human body, preventing diseases, etc.<\/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\/medical-device-and-ivd-emergency-in-india\/#Guidelines_on_In-Vitro_Diagnosis_Kit_Usage\" >Guidelines on In-Vitro Diagnosis Kit Usage<\/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\/medical-device-and-ivd-emergency-in-india\/#Requirement_of_Registration\" >Requirement of Registration<\/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\/medical-device-and-ivd-emergency-in-india\/#Rapid_Response_Regulatory_Framework_for_Covid-19\" >Rapid Response Regulatory Framework for Covid-19<\/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\/medical-device-and-ivd-emergency-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Guidelines_on_In-Vitro_Diagnosis_Kit_Usage\"><\/span>Guidelines on In-Vitro Diagnosis Kit Usage<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO have currently \u2018Notified\u2019 only certain devices that\nare subject to registration. All the products qualifying the definition of a\nmedical device are lawfully subject to this regulation. With the outbreak of\nCOVID-19 pandemic there were high demands for IVD test kits, drugs, hand\nsanitizer, vaccines and surgical disinfectants and these have been put on an\nurgent priority list for CDSCO and have been expedited for the concerned\napprovals.<\/p>\n\n\n\n<p><em><strong>The CDSCO shall provide guidance on such regulations and few details are as given below:-<\/strong><\/em><\/p>\n\n\n\n<ul><li>Any firm can directly approach DCG (I) through Public Relations Office if they have In-vitro Diagnostic Kit under development for Covid-19 diagnosis for seeking guidance for regulatory pathway.<\/li><li>Any firm in any other country can directly approach DCG (I) through Public Relations Office having In-vitro Diagnostic Kit already approved for Covid-19 diagnosis regarding expedited review and approval for marketing in <em><strong>India<\/strong><\/em><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/India\"><em><strong>[1]<\/strong><\/em><\/a><\/sup>.<\/li><li>Depending upon the type &amp; nature of the diagnostic kit and the existing data on the product and the evidence of available clinical performance the data requirement for clinical performance evaluation may be deferred or waived.<\/li><li>Applications to manufacture or import In-Vitro Diagnostic Kit for test and further evaluation of performance may be processed on priority basis within 7 days.<\/li><li>Application to import and manufacture and for conducting performance evaluation of In-Vitro Diagnostic Kit for sale and distribution would be processed on priority through expedited approval or review.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Uses of Medical Devices<\/h3>\n\n\n\n<p>The government notified The Medical Device (Amendment) Rules, 2020\non February 11, 2020, \u201c<strong>MDR Amendment<\/strong>\u201d. The MDR\nAmendment has introduced two changes to the rules.<\/p>\n\n\n\n<ul><li>The first is bringing a new chapter for Newly Notified Medical Devices registration by their concerned importers and manufacturers. <\/li><li>The second is excluding the 37 categories of notified medical devices or already regulated devices from the necessity of registration as introduced by the new chapter.<\/li><\/ul>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/documents-required-for-medical-device-registration-online\/\">Know the Checklist for Documents Required For Medical Device Registration in India<\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirement_of_Registration\"><\/span> Requirement of Registration <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>The most basic requirement of registration is:-<\/em><\/strong><\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"688\" height=\"371\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Requirement-of-Registration.png\" alt=\"Requirement of Registration\" class=\"wp-image-29376\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Requirement-of-Registration.png 688w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Requirement-of-Registration-300x162.png 300w\" sizes=\"(max-width: 688px) 100vw, 688px\" \/><\/figure><\/div>\n\n\n\n<ul><li>The importers or\nmanufacturers of Newly Notified Medical Devices are obligated to compulsorily\nhave the registration of their medical devices before October 1, 2021 with the\nDrugs Controller General of India (\u201cDCGI\u201d).<\/li><li>From April 1, 2020\nthrough a committed online portal called \u201cOnline System for Medical Devices\u201d, the\nDCGI will begin accepting registration applications. <\/li><li><strong><em>A compliance\ncertificate<\/em><\/strong> with ISO-13485 is obligatory\nfor registration of the Newly Notified Medical Device. Therefore, the manufacturer\nor the importer of a registered medical device shall ensure that the ISO 13485 requirements\nare met at all times.<\/li><li><strong><em>Requirement to obtain a license \u2013<\/em><\/strong> it is not compulsory to have a registration number for obtaining a\nlicense. Therefore, the application for license can be made anytime after April\n1, 2020 or as the DCGI may specify in future. License shall be issued by the\nconcerned authorities to the manufacturer or the importer.<em><\/em><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Rapid_Response_Regulatory_Framework_for_Covid-19\"><\/span>Rapid Response Regulatory Framework for Covid-19 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Due to the rapid spread of covid-19 in various countries it\nwas decided to fast track the regulatory approval process in consultation with\nDCGI to deal with the applications for development of vaccines, diagnostic,\nprophylactics and therapeutics for covid-19 as per following:-<\/p>\n\n\n\n<p>The authorised committee of Review Committee on Genetic\nManipulation (RCGM) and CDSCO was constituted to give permission for import or\nexchange and to examine the applications for approvals.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Device\nTypes and Eligibility Criteria<\/h3>\n\n\n\n<p>The CDSCO is creating a Corona virus unit to deal with inquiries on the progress of these products.\u200b\u200b Only notified devices will have to subject itself under the regulation by CDSCO and the other devices can be sold in India and imported by merely complying with the universal customs requirement. The given below is the list which focuses on the regulatory status under the COVID-19 critical care devices condition.<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong><em>Device type<\/em><\/strong>\n  <\/td><td>\n  <strong><em>Regulatory status<\/em><\/strong>\n  <\/td><\/tr><tr><td>\n  Facemasks\/respirators\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Ventilators\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Dialysis\/infiltration\n  machines and consumables<strong>*<\/strong>\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Dialysis\n  solution\n  <\/td><td>\n  Registration\n  required\n  <\/td><\/tr><tr><td>\n  Endotracheal\n  tubes\n  <\/td><td>\n  Registration\n  required\n  <\/td><\/tr><tr><td>\n  Non-invasive\n  ventilators (bipap) machines\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Gowns,\n  gloves\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Oxygen\n  masks (venturi masks)\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Central\n  lines\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Arterial\n  lines\n  <\/td><td>\n  Registration\n  not required\n  <\/td><\/tr><tr><td>\n  Vascular\n  catheters\n  <\/td><td>\n  Registration\n  required\n  <\/td><\/tr><tr><td>\n  IVD test\n  kits\n  <\/td><td>\n  Registration\n  required\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>The devices with the requirement of registration shall be\nmandatorily registered and shall abide with the CDSCO.<\/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 CDSCO has released guidelines for validation and batch testing for Covid-19 diagnostic kits along with the Centres approved to provide validation and batch testing of kits for covid-19. With the spread of corona virus the CDSCO has regulated many medical devices and In-Vitro diagnostic devices usage in India and the same has been successfully proved now.<\/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\/regulation-for-all-medical-devices-under-cdsco-directive\/\">Regulation for all Medical Devices under CDSCO Directive<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The regulation of Medical devices and In vitro diagnostic device (IVDs) in India are managed by the Drug Controller General of India (DCGI) which is within the Central Drugs Standard Control Organization (CDSCO). The regulatory structure for medical devices and In vitro diagnostic device (IVDs) is established on drug regulations under the&nbsp;Drugs and Cosmetics Act,&nbsp;1940and&nbsp;Rules [&hellip;]<\/p>\n","protected":false},"author":33,"featured_media":29375,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[1691],"acf":{"service_id":"385"},"authorName":"Kandarp Vanita","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/02\/image_2021_02_01T09_09_44_024Z.png","authorDescription":"Kandarp Vanita has done masters in Corporate and Commercial Law from WB National University of Juridical Sciences. She has 3 yrs of experience in drafting legal documents &amp; dissertations. Being a curious reader, she is also passionately into providing legal backups and comprehensive understandings in every aspect of Law to the firms.","postViews":3841,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29363"}],"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\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=29363"}],"version-history":[{"count":7,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29363\/revisions"}],"predecessor-version":[{"id":43525,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29363\/revisions\/43525"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/29375"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=29363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=29363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=29363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}