{"id":46061,"date":"2022-08-04T10:52:21","date_gmt":"2022-08-04T05:22:21","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46061"},"modified":"2022-08-04T10:55:59","modified_gmt":"2022-08-04T05:25:59","slug":"difference-between-notified-and-non-notified-medical-device","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/difference-between-notified-and-non-notified-medical-device\/","title":{"rendered":"Difference Between Notified and Non-Notified Medical Device"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Medical equipment has traditionally been largely\nunregulated in India. That has transformed recently. Medical Devices Rules 2017\nhave become effective as of January 1st, 2018, according to Ministry of Health\nand Family Welfare Notification No. G.S.R, 78(E) dated January 31, 2017. There\nhas been different regulations for notified and non-notified medical devices. In\nthis write-up, we will discuss the difference between notified and non-notified\nmedical devices.<\/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\/difference-between-notified-and-non-notified-medical-device\/#What_is_CDSCO\" >What is 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\/difference-between-notified-and-non-notified-medical-device\/#Notified_and_Non-Notified_Medical_Device-_Differences\" >Notified and Non-Notified\nMedical Device- Differences<\/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\/difference-between-notified-and-non-notified-medical-device\/#Indias_Medical_Device_Regulations_for_Notified_and_Non-Notified_Medical_Device\" >India&#8217;s Medical Device Regulations for Notified and Non-Notified\nMedical 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\/difference-between-notified-and-non-notified-medical-device\/#What_is_the_Classification_of_the_Notified_Devices\" >What is the Classification of\nthe Notified Devices?<\/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\/difference-between-notified-and-non-notified-medical-device\/#Documents_Required_for_the_List_of_Newly_Notified_Devices\" >Documents Required for the List\nof Newly Notified Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/difference-between-notified-and-non-notified-medical-device\/#Initiating_Licensing_Activities_When_Should_They_Be_Started\" >Initiating\nLicensing Activities: When Should They Be Started?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/difference-between-notified-and-non-notified-medical-device\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_CDSCO\"><\/span>What is CDSCO?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In accordance with the regulations of the <strong>Drugs &amp; Cosmetics Act 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup> and Rules 1945, the Central Drugs Standard Control Organization, or <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>, is the regulatory body for the Indian medical device industry. Every country around the globe has a specific regulatory body under the ministry of health to handle all facets of pharmaceuticals and both notified and non-notified medical devices.<\/p>\n\n\n\n<p>The Central Drug Standard Control Organization (CDSCO) of India is responsible for issuing licences for importation, manufacturing for sale or for distribution and sale, stocking, exhibiting, or offering for sale. All import device licencing as well as Class C and Class D <a href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-devices-manufacturing-registration-requirement\/\"><strong>medical device manufacturing<\/strong><\/a>, loan, and wholesale licences are handled by CLA. Manufacturing, loan, and wholesale licences for Class A and Class B medical devices are handled by SLA. For Class A and Class B medical device manufacturers, SLA designates a Notified Body to verify the requirements of the QMS (Quality Management System) and Technical Review. For the inspection of the manufacturing facility for Class C and Class D medical devices as well as for Technical Review, CLA may use the services of a Notified Body.<\/p>\n\n\n\n<p>By submitting the application and obtaining the\nrequired licence, which leads to a limited conformity assessment process,\nregulated medical devices transported from outside of India that have\npreviously received approval in the U.S.,&nbsp;Canada, Japan, or Australia may\nbe legally sold in India. In such circumstances, device registration applicants\nshould include with their application,&nbsp;all supporting documentation for\nprior approvals. A wholesale license-holding importer who is in charge of\nsubmitting a device registration application&nbsp;must be designated by foreign\nmanufacturers as well.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Notified_and_Non-Notified_Medical_Device-_Differences\"><\/span>Notified and Non-Notified\nMedical Device- Differences<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Non-Notified\nDevices<\/strong>: In India, there is no\nregulation of any devices that are not on the list of Notified Devices. These\ndevices must be listed in the CDSCO portal. Foreign companies that want to sell\nthese devices in India must have an IAA (Indian Authorised Agent).<\/p>\n\n\n\n<p><strong>Notified\nDevices<\/strong>: The Notified list contains\n37 categories of devices that are regulated by the CDSCO and need prior\napproval from the CDSCO before being marketed in India. With each type of application\nform submitted to the CDSCO, a different set of supporting documents is needed.<\/p>\n\n\n\n<p>The selection of applications varies\naccording to the device type, applicant characteristics, operations, and home\ncountry approval. The CDSCO grants licences for device testing, import, or\nmanufacturing after carefully evaluating each application.<\/p>\n\n\n\n<p>In accordance with the Medical Device (Amendment) Rules &#8211; February 2020, which came into effect in April 2020, all non-notified medical devices may voluntarily be registered with the Central Licensing Authority (CLA) through the medical device online system.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indias_Medical_Device_Regulations_for_Notified_and_Non-Notified_Medical_Device\"><\/span><strong>India&#8217;s Medical Device Regulations for Notified and Non-Notified\nMedical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Global medical\ndevice manufacturers have an excellent opportunity in India, where a large number\nof notified and non-notified medical devices are imported. The current low\nper-person expenditure on medical devices is expected to drive significant\ngrowth in the Indian medical device industry.<\/p>\n\n\n\n<p>The Notified\nDevices are the devices that are regulated under the Medical Devices Rules\n(MDR), 2017 by the CDSCO &#8211; the Health Agency in India that oversees the\nregulation of notified and non-notified medical devices. In February 2020, the\nCDSCO issued two notifications, including the Medical Devices (Amendment)\nRules, 2020, which went into effect on April 1, 2020. Medical devices were also\ngiven a new definition as part of the other notification. As a result of the\nchange and the new definition, the CDSCO is now in charge of overseeing all\ndevices. Only 37 classes of medical&nbsp;devices and IVDs were governed in\nIndia prior to these notifications. &#8220;Newly Notified Devices&#8221; are the\nnew devices that have been brought under the jurisdiction of the CDSCO.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_Classification_of_the_Notified_Devices\"><\/span>What is the Classification of\nthe Notified Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The &#8220;Newly\nNotified Devices&#8221; are divided into 24 medical device categories and 3 IVD\ncategories. According to the risk associated with each device, both Notified\nand Newly Notified devices are categorised into 4 Classes: A, B, C &amp; D.\nThere are low-risk Class A devices and high-risk Class D devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_the_List_of_Newly_Notified_Devices\"><\/span>Documents Required for the List\nof Newly Notified Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>For the listing,\nmanufacturers must send in basic information, such as the device of the\nmanufacturer and where it is made, information about the device, an ISO 13485:2016\ncertificate, a Free Sales Certificate (FSC) or a Certificate of Free Sales\n(CFS) (granted by the Country of Origin (COO) for imported devices), and an\nundertaking by the applicant.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Initiating_Licensing_Activities_When_Should_They_Be_Started\"><\/span>Initiating\nLicensing Activities: When Should They Be Started?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Importers of all\ndevice classes should initiate their licencing activities at least one year\nprior to the legislative deadlines imposed by the Agency, in case of newly\nnotified devices or the expected launch date of a device on the Indian market,\nor in the case of Notified devices. The Indian manufacturers of Class A devices\nshould begin working on the application within three to four months, Class B\ndevice manufacturers within six months, and Class C and D device manufacturers\nwithin five to seven months prior to the legislative deadlines imposed by the\nAgency in the case of newly notified devices or the target date for the launch\nof the device on the Indian market or in the case of notified devices.<\/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>India is regarded as one of the top global Medical Device markets, with device imports accounting for the majority of its revenue. The Central Drug Standard Control Organization or CDSCO regulates both notified and non-notified medical devices sold in India. The CDSCO is led by the Drug Controller General of India (DCGI), and the approval authority is split between the Centre Licensing Authority (CLA) and the State Licensing Authority (SLA) (SLA). Every day, the Indian Medical Device Regulations become more stringent. The CDSCO currently notifies and regulates 37 categories of medical devices in India. It is anticipated that the regulatory scope of the CDSCO regulation will expand in the coming years to include more notified and non-notified medical device categories.<\/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>Medical equipment has traditionally been largely unregulated in India. That has transformed recently. Medical Devices Rules 2017 have become effective as of January 1st, 2018, according to Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated January 31, 2017. There has been different regulations for notified and non-notified medical devices. In this write-up, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46064,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2559],"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":6572,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46061"}],"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=46061"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46061\/revisions"}],"predecessor-version":[{"id":46079,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46061\/revisions\/46079"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46064"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46061"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46061"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46061"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}