{"id":37880,"date":"2021-11-15T12:23:11","date_gmt":"2021-11-15T06:53:11","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=37880"},"modified":"2021-11-15T12:23:13","modified_gmt":"2021-11-15T06:53:13","slug":"cdcso-extends-the-application-submission-date-of-license-for-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/","title":{"rendered":"CDCSO Extends the Application Submission Date of License for Medical Devices"},"content":{"rendered":"\n<p class=\"has-drop-cap\"><strong>In relief to importers &amp; <\/strong>manufacturers of medical devices, the apex regulator CDSCO, i.e. Central Drug Standard Control Organisation, has extended the date to furnish the application form for license to June 30, 2022.The decision was taken as the manufacturers &amp; importers of <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical devices<\/strong><\/a> and equipment have failed to comply with the requirement of securing a license from the said authority within the stipulated timeframe. The license for medical device can be secured after filing a prescribed application on the official portal. <\/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\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/#What_types_of_medical_devices_are_covered_in_the_recent_Notification\" >What\ntypes of medical devices are covered in the recent Notification?<\/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\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/#Medical_Device_Rules_Mandates_ManufacturerImporter_to_Secure_License_for_Medical_devices\" >Medical\nDevice Rules Mandates Manufacturer\/Importer to Secure License for Medical\ndevices<\/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\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/#Casting_light_on_the_Notification_Rolled_out_by_CDSCO\" >Casting\nlight on the Notification Rolled out by CDSCO.<\/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\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/#Functions_Performed_by_CDSCO_in_India\" >Functions\nPerformed by CDSCO in India<\/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\/cdcso-extends-the-application-submission-date-of-license-for-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_types_of_medical_devices_are_covered_in_the_recent_Notification\"><\/span>What\ntypes of medical devices are covered in the recent Notification?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To ensure uninterrupted access to\nmedical-based devices notified as drugs while the new regulatory order under\nMDR, i.e. Medical Device Rules, is enforced, CDSCO has decided that a\nmanufacturer\/producer who is already engaged with the manufacturing\n\/importation of medical devices, including MRI equipment, CT scan equipment\n&amp; whose application already been furnished the apex regulator or State\nLicense Authority for grant of the license would be considered valid. <\/p>\n\n\n\n<p>Furthermore, it also confirmed that the\nmanufacturer\/importer can continue to perform their business activities up to\n30.06.2022 or till the duration the said authorities takes a decision on the\nsaid application, whichever is earlier. <\/p>\n\n\n\n<p>The Central Government, in association\nwith the Drugs Technical Advisory Board, had specified the below-mentioned\ndevices for the use in patients as drugs with effect from 1\/4\/2020, viz; <\/p>\n\n\n\n<ul><li>All implantable medical devices;<\/li><li>CT scan Equipment;<\/li><li>Defibrillators;<\/li><li>MRI Equipment;<\/li><li>Dialysis Machine;<\/li><li>X-Ray Machine;<\/li><li>PET Equipment;<\/li><li>Bone marrow cell separator<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Rules_Mandates_ManufacturerImporter_to_Secure_License_for_Medical_devices\"><\/span>Medical\nDevice Rules Mandates Manufacturer\/Importer to Secure License for Medical\ndevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per the new notification norms cited\nin Medical Device Rule (MDR), 2017, the manufacturers as well as importers are\nmandated to secure an import or manufacturing license from the apex regulator\nor a State Licensing Authority of the specified eight medical devices with\neffect from April.<\/p>\n\n\n\n<p>But, in this context, the stakeholders\nexpressed their concern that due to the Cornovirus disruption, there is\nunpreparedness in fulfilling the regulatory requirements within the given\ntimelines, which may disrupt the supply chain. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Casting_light_on_the_Notification_Rolled_out_by_CDSCO\"><\/span>Casting\nlight on the Notification Rolled out by CDSCO.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>In view of the above, the apex regulator i.e. CDSCO, has rolled out a notification, stating; <\/em><\/strong><\/p>\n\n\n\n<p>&#8220;Now, therefore, in order to ensure\na seamless transition of importers\/manufactures, continuity of supply chain as\nwell as the access to the patients, with the consent of MoHFW, it has been\ndecided that in case a prevailing manufacturer\/importers who is already engaged\nwith the manufacturing\/importation of any those devices, &amp; whose\napplication form has been furnished to the concerned authorities for the grant\nof the license relating to the said device(s) under norms of MDR, 2017 by\n18.04.2021, the said application shall stand valid and the\nimporter\/manufacturer, can continue to perform their business undertaking\nrelating to said devices up to 30.06.2022 or till the time the concerned\nauthority finalize the decision on the said application, whichever is earlier.<\/p>\n\n\n\n<p>Moreover, the notice confirmed that the\napplicant who has furnished an incomplete application (furnished by or before\nApril 18, 2021) must furnish all the required documents to the authority by\n31.03.2022. The notice further clarified that the Central Licensing Authority\nor State Licensing Authority should reject this application within three months\nfrom the receipt date of the complete application <\/p>\n\n\n\n<p>Moreover, the importer\/ manufacturer of\nthe medical devices has to secure a relevant license for the aforementioned\nsaid devices by or before July 30, 2022. The importer\/manufacturer must print\nthe license number on the label w.e.f 01\/07\/2022<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Functions_Performed_by_CDSCO_in_India\"><\/span>Functions\nPerformed by CDSCO in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>The Central Drugs Standard Control Organisation (aka CDSCO) under the aegis of <\/strong>the <strong><em>Ministry of Health &amp; Family Welfare<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Ministry_of_Health_and_Family_Welfare\"><strong><em>[1]<\/em><\/strong><\/a><\/sup>, Directorate General of Health Services, GOI is the national regulatory authority (aka NRA) of India. The authority is also responsible for disbursing License for Medical device. <\/p>\n\n\n\n<p>It is headquartered at FDA Bhawan, Kotla\nRoad, New Delhi &amp; also possesses 6 zonal offices, four sub-zonal offices,\n13 port offices &amp; 7 labs spread established pan India.<\/p>\n\n\n\n<p><strong>The authority operates under the ambit of\n<\/strong>the Drugs &amp;\nCosmetics Act, 1940 and rules 1945. It aims to ensure seamless implementation\nof the provisions cited in the said Act to ensure the well-being and safety of\nthe patient by regulating the drugs &amp; cosmetics. <\/p>\n\n\n\n<p>Further, the apex regulator is\ncontinually striving to improve accountability, transparency, &amp; uniformity\nof its services to ensure better safety and quality of the medical product\nproduced, shipped, &amp; distributed in the country.<\/p>\n\n\n\n<p><em><strong>As per the governing Act, CDSCO is liable for;<\/strong><\/em><\/p>\n\n\n\n<ul><li>Approving Clinical Trials of drugs <\/li><li>Underpinning standards for Drugs <\/li><li>Curbing the movement of overseas drugs and establishing relevant measures for the same<\/li><li>Prompting State Drug Control Organizations by rendering expert advice for effective enforcement of the Drugs and Cosmetics Act<\/li><\/ul>\n\n\n\n<p>Moreover, CDSCO, in association with the\nstate regulators, is liable for grant of licenses of certain categories of\ndrugs such as I. V. Fluids, blood and blood products, Vaccine and Sera.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The said Notification released by CDSCO aims to extend the application submission date of license for aforesaid medical devices till next year, i.e. June 30, 2022. This came as a great relief for the manufacturers and importers of the devices operating in India. Applicants who have already submitted the license application by April 18, 2021, shall continue to undertake their business undertakings up to June 30, 2022. The authority shall disburse License for Medical device after scrutinizing the application &amp; submitted credentials. <\/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-extension-of-medical-device-compliance-deadlines-to-2021\/\">CDSCO: Extension of Medical Device Compliance Deadlines to 2021 <\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In relief to importers &amp; manufacturers of medical devices, the apex regulator CDSCO, i.e. Central Drug Standard Control Organisation, has extended the date to furnish the application form for license to June 30, 2022.The decision was taken as the manufacturers &amp; importers of medical devices and equipment have failed to comply with the requirement of [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":37903,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2024],"acf":{"service_id":"385"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":3075,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/37880"}],"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\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=37880"}],"version-history":[{"count":22,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/37880\/revisions"}],"predecessor-version":[{"id":37902,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/37880\/revisions\/37902"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/37903"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=37880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=37880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=37880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}