{"id":11783,"date":"2022-09-02T06:48:45","date_gmt":"2022-09-02T06:48:45","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11783"},"modified":"2022-09-02T06:51:30","modified_gmt":"2022-09-02T06:51:30","slug":"difference-between-notified-non-notified-medical-devices","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/difference-between-notified-non-notified-medical-devices\/","title":{"rendered":"Difference between Notified &#038; Non-Notified Medical Devices"},"content":{"rendered":"\n<p>CDSCO stands for Central Drugs Standard\nControl organisation. This entity is responsible for the regulation of drugs in\nIndia. CDSCO works under the ambit of the Directorate General of health\nservices, which is governed by the Ministry of health and family welfare. CDSCO\nis responsible for conducting drug trials, keeping track of the quality of the\nimported drug, and laying down standards for drug manufacturers in the country.\nIn this article, we shall look into the regulations of CDSCO regarding Notified\n&amp; Non-Notified Medical Devices.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a55975c8fdfd\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a55975c8fdfd\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/swaritadvisors.com\/blog\/difference-between-notified-non-notified-medical-devices\/#Notified_medical_devices\" title=\"Notified medical devices\">Notified medical devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/difference-between-notified-non-notified-medical-devices\/#Non-notified_medical_devices\" title=\"Non-notified medical devices\">Non-notified 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:\/\/swaritadvisors.com\/blog\/difference-between-notified-non-notified-medical-devices\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Notified_medical_devices\"><\/span>Notified medical devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>Meaning:<\/strong><\/li><\/ul>\n\n\n\n<p>The medical\ndevice rules of 2017 have regulated devices; these devices are called notified devices.\nCDSCO is the government agency that is responsible for overseeing these medical\ndevices. Till now, two notifications have been released by the CDSCO. The\nnotifications have brought in significant changes in the regulations; these\nare:<\/p>\n\n\n\n<ul><li>A new definition of drugs and medical devices was announced \u2013 which widened the definition of medical devices, and now many aspects fall under it.<\/li><li>The CDSCO shall regulate all devices. Previously only 37 devices were listed to be regulated by CDSCO- hence they are called &#8220;newly Notified       Devices.<\/li><\/ul>\n\n\n\n<ul><li><strong>Classification: <\/strong><\/li><\/ul>\n\n\n\n<p>The second point\nof difference between Notified &amp; Non-Notified Medical Devices is that\naccording to the newly notified devices, there are 3 categories of IVD and 24\ncategories of medical devices. However, their division is into four classes.\nThis division is based on the risk they pose to human life, with Class A being\nharmless till Class D being the riskiest. <\/p>\n\n\n\n<ul><li><strong>Licensing authorities: <\/strong><\/li><\/ul>\n\n\n\n<p>DCGI- Drugs controller general of India and <strong>CDSCO- Central Drugs Standard Control organisation<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>.<\/p>\n\n\n\n<ul><li><strong>License\u00a0Requirements:<\/strong><\/li><\/ul>\n\n\n\n<p>The domestic\nmanufacturer must obtain a Manufacturing license (ML) to produce and sell the\nmedical device in the country. The foreign manufacturer must obtain an import\nlicense (IL) to market its products in India.<\/p>\n\n\n\n<ul><li><strong>Document Requirements:<\/strong><\/li><\/ul>\n\n\n\n<p>ISO\ncertification 13485:2016 and free sales Certificate from the country of origin\nare key documents that are required for notified medical devices, apart from\nthe usual documents.<\/p>\n\n\n\n<ul><li><strong>Regulatory Compliances:<\/strong><\/li><\/ul>\n\n\n\n<p>The newly notified devices require the manufacturers and importers to get their devices registered by October 1, 2021. The mandatory registration for notified devices has a varying timeline; these are: for Class A and Class B devices (non-risk\/ mild risk) have to be registered before August 11, 2022, whereas Class C and Class D (moderate risky\/ high risk) can get their device registered by August 11, 2023.<\/p>\n\n\n\n<ul><li><strong>Initiating licensing Activities:<\/strong><\/li><\/ul>\n\n\n\n<p>It is\nrecommended that the manufacturers must begin the licensing activities one year\nprior to the timelines enlisted by the government. It is suggested that Class A\n\u2013 Class B devices should start licensing process 3-6 months prior to the\nauthorised date and Class C and Class D notified devices must start 5-7 months\nprior to the authorised date.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Non-notified_medical_devices\"><\/span>Non-notified medical devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>Meaning:<\/strong><\/li><\/ul>\n\n\n\n<p>The major difference between Notified &amp; Non-Notified Medical Devices is that Non-notified medical devices are every medical device that has not been mentioned under notified medical devices in the official gazette released by the government of India.<\/p>\n\n\n\n<ul><li><strong>Classification:<\/strong><\/li><\/ul>\n\n\n\n<p>There are a\ntotal of 1866 medical devices under the non-notified category as of now.\nSimilarly, like notified devices, these are categorised into 24 medical devices\nand 3 In vitro diagnostic devices. These devices have also been classified\nbased on their risk factor from Class A (least risky) to Class D (Most risky).<\/p>\n\n\n\n<ul><li><strong>Licensing Authorities:<\/strong><\/li><\/ul>\n\n\n\n<p>Licensing\nauthorities include the State licensing authority (SLA) and the Centre\nLicensing Authority (CLA) in conformation with the DGCI.<\/p>\n\n\n\n<ul><li><strong>License\u00a0Requirements:<\/strong><\/li><\/ul>\n\n\n\n<p>The stakeholders\nsuch as manufacturer, seller and importers must possess the manufacturing\nlicense, Wholesale license or retail license as applicable to deal with\nnon-notified medical devices.<\/p>\n\n\n\n<ul><li><strong>Document Requirements:<\/strong><\/li><\/ul>\n\n\n\n<p>There is no\nsignificant difference in the documents between Notified &amp; Non-Notified\nMedical Devices. The Main documents required for registration of Non-notified\nmedical devices are similar to notified devices ISO certification 13485:2016,\nand free sales certificates are mandatory.<\/p>\n\n\n\n<ul><li><strong>Regulatory Compliances: <\/strong><\/li><\/ul>\n\n\n\n<p>The manufacturers of Non-notified medical devices must make a voluntary registration under the <strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\">CDSCO<\/a><\/strong>. The government has not levied any fee on this voluntary registration. The earlier date for registration of non-notified medical devices was September 30 2021, which the authorities have extended by one year upon the request of various stakeholders.<\/p>\n\n\n\n<ul><li><strong>Initiating licensing Activities:<\/strong><\/li><\/ul>\n\n\n\n<p>It is advised\nthat all the stakeholders apply for the Non-notified medical products\nregistration immediately. Before the stipulated deadline, the manufacturer,\nimporters, and sellers only have to produce ISO and FSC certifications with no\nregistration fee.<\/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 article listed the differences between Notified &amp; Non-Notified Medical Devices. The regulatory authorities have made these differences based on the product&#8217;s need, risk, purpose and functionality. In a comparison between Notified &amp; Non-Notified Medical Devices, the notified medical devices have a more stringent registration process, and the non-notified ones have a simpler registration process. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/\">CDSCO Approval for Voluntary Registration of Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO stands for Central Drugs Standard Control organisation. This entity is responsible for the regulation of drugs in India. CDSCO works under the ambit of the Directorate General of health services, which is governed by the Ministry of health and family welfare. CDSCO is responsible for conducting drug trials, keeping track of the quality of [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11784,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11783"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=11783"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11783\/revisions"}],"predecessor-version":[{"id":11788,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11783\/revisions\/11788"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11784"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}