{"id":29528,"date":"2021-04-30T14:35:23","date_gmt":"2021-04-30T09:05:23","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=29528"},"modified":"2021-04-30T14:35:26","modified_gmt":"2021-04-30T09:05:26","slug":"cdsco-extension-of-medical-device-compliance-deadlines-to-2021","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/","title":{"rendered":"CDSCO: Extension of Medical Device Compliance Deadlines to 2021"},"content":{"rendered":"\n<p class=\"has-drop-cap\">This year was the most important year for the<strong> <\/strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device companies <\/strong><\/a>from the perspective of the medical devices and the regulations since the Medical Device Rules, 2017 has came into force on January 01, 2018. The Government has planned to amend the regulations for medical devices to considerably expand the medical device regulations reach. As the medical device sector remained unaffected by the outbreak of COVID-19 pandemic, the regulators have provided relaxations in the regulatory compliance as could be sufficient. India\u2019s pharmaceutical and medical device regulator the Central Drugs Standard Control Organization (CDSCO)<strong> <\/strong>is a body under Directorate General of Health Services, Ministry of Health &amp; Family Welfare. CDSCO is the National Regulatory Authority (NRA) of India and it has issued an extension for numerous types of different medical devices to register for getting the authorization in market. In this article, we shall deal with some of the important developments in the medical devices and regarding Extension of medical device compliance deadlines to 2021.<\/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\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/#The_CDSCO_Guidelines\" >The CDSCO Guidelines<\/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\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/#Notification_to_Regulate_All_Medical_Devices\" >Notification to Regulate All 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:\/\/corpbiz.io\/learning\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/#The_Complete_List_of_Notified_Devices\" >The Complete List of Notified Devices<\/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\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/#New_Registration_for_the_Manufacturers\" >New Registration for the Manufacturers<\/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\/cdsco-extension-of-medical-device-compliance-deadlines-to-2021\/#_Conclusion\" >&nbsp;Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_CDSCO_Guidelines\"><\/span>The CDSCO Guidelines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Effective from April 1, 2020 it shall be obligatory for the medical devices to get itself registered in India. Before the amendment, there were only 37 categories of medical devices were regulated but from 1<sup>st<\/sup> April 2020 all the medical devices have to oblige with the registration. The applicability for the extension of medical devices is particularly for all the <strong>importers and manufacturers<\/strong> of medical devices. <\/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\n\n\n<h3 class=\"wp-block-heading\">Government Notification<\/h3>\n\n\n\n<p>The <em><strong>Government of India<\/strong><\/em><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Government_of_India\"><em><strong>[1]<\/strong><\/em><\/a><\/sup> issued two notifications on February 11, 2020, i.e. The Medical Devices (Amendment) Rules, 2020 and a new definition of the medical devices. The collective consequence of these two notifications is that all the medical devices shall be brought under the cover of safety and quality regulation from the date April 1, 2020 effective for both notifications. <\/p>\n\n\n\n<p>The\nCDSCO&nbsp;extension of medical devices&nbsp;signifies that the medical device\ntypes that were originally expected to register itself under India\u2019s Medical\nDevice Rules, 2017 by the time period of January 1, 2020, can now register with\nthe extension of medical devices until January 2021. CDSCO\u2019s&nbsp;expansion&nbsp;of\nthe definition and extension of the medical device aligns with the Global\nHarmonization Task Force (GHTF), which is efficiently increasing the extent of\nproducts that shall require registration as devices with the purpose of being\nsold in India.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Notification_to_Regulate_All_Medical_Devices\"><\/span>Notification to Regulate All Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According\nto the notification that is effective from April 1, 2020, all the medical\ndevices that fall under the definition given below shall be regulated as \u201cdrug\u201d\nunder the MDR and DCA.<\/p>\n\n\n\n<p>All devices including an apparatus, instrument, implant, appliance material or any other article used in combination or alone, with a software or an accessory, and the manufacturer intended to use it specially for animals and human beings or that does not accomplish the prime intended action on animals or human body by any immunological, pharmacological or metabolic means, but which may help in its intended purpose by such means or for more than one of the specific purposes of:-<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Notification-to-Regulate-All-Medical-Devices.png\" alt=\"Notification to Regulate All Medical Devices\" class=\"wp-image-29547\" width=\"551\" height=\"330\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Notification-to-Regulate-All-Medical-Devices.png 1000w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Notification-to-Regulate-All-Medical-Devices-300x180.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/04\/Notification-to-Regulate-All-Medical-Devices-768x460.png 768w\" sizes=\"(max-width: 551px) 100vw, 551px\" \/><\/figure><\/div>\n\n\n\n<ul><li>Treatment,\ndiagnosis, monitoring, prevention or alleviation of any disorder or disease,\nassistance for any kind of disability or injury;<\/li><li>Replacement,\nmodification, investigation, or support of a physiological process or of the anatomy\nor;<\/li><li>disinfection\nof medical devices;<\/li><li>Sustaining\nor supporting life; and<\/li><li>Control\nof conception.<\/li><\/ul>\n\n\n\n<p>The\nnew definition mentioned above is intended to cover up all the medical devices\nunder the extension of medical device. Thus, because of this definition all the\nmedical devices getting sold in India shall be regulated from April 1, 2020, after\nthe taking effect of the definition.<\/p>\n\n\n\n<p>The\nRules states that these medical devices ought to be registered with the Central\nLicensing Authority by an online identified portal as has been established by\nthe Central Drugs Standard Control Organisation (CDSCO). The registration will\nbe voluntary for a time period of 18 months, after that it shall be mandatory.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Complete_List_of_Notified_Devices\"><\/span>The Complete List of Notified Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Disposable\nHypodermic Syringes <\/li><li>Disposable\nHypodermic Needles <\/li><li>Disposable\nPerfusion Sets <\/li><li>IVD\nDevices for HIV, HBsAg, HCV <\/li><li>Cardiac\nStents <\/li><li>Drug\nEluting Stents <\/li><li>Catheters <\/li><li>Intra\nOcular Lenses <\/li><li>Cannulae <\/li><li>Bone Cements <\/li><li>Heart\nValves <\/li><li>Scalp\nVein Set <\/li><li>Orthopaedic\nImplants <\/li><li>Internal\nProsthetic Replacements <\/li><li>Blood\nGrouping Sera <\/li><li>Ligatures,\nSutures and Staplers <\/li><li>Intra\nUterine Devices (CuT) <\/li><li>Condoms <\/li><li>Tubal\nRings <\/li><li>Surgical\nDressings <\/li><li>Umbilical\ntapes <\/li><li>Blood\/Blood\nComponent Bags <\/li><li>Ablation\nDevices <\/li><li>Organ\nPreservation Solution <\/li><li>Blood\nPressure Monitors (Effective January 1<sup>st<\/sup>, 2021) <\/li><li>Digital\nThermometers (Effective January 1<sup>st<\/sup>, 2021) <\/li><li>Glucometers\n(Effective January 1<sup>st<\/sup>, 2021) <\/li><li>Nebulizers\n(Effective January 1<sup>st<\/sup>, 2021) <\/li><li>X-Ray\nMachines (April 1<sup>st<\/sup>, 2021) <\/li><li>CT\nScan Equipment (April 1<sup>st<\/sup>, 2021) <\/li><li>MRI\nEquipment (April 1<sup>st<\/sup>, 2021) <\/li><li>PET\nEquipment (April 1<sup>st<\/sup>, 2021) <\/li><li>Defibrillators\n(April 1<sup>st<\/sup>, 2021) <\/li><li>Dialysis\nMachines (April 1<sup>st<\/sup>, 2021) <\/li><li>Bone\nMarrow Cell Separators (April 1<sup>st<\/sup>, 2021) <\/li><li>All\nImplantable Medical Devices (April 1<sup>st<\/sup>, 2021) <\/li><li>Ultrasound\nDevices (November 1<sup>st<\/sup>, 2021) <\/li><li>Disinfectants\nand insecticides as specified in&nbsp;Medical Device Rules, 2017 <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"New_Registration_for_the_Manufacturers\"><\/span>New Registration for the Manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Under Chapter IIIA:\nRegistration of Certain Medical Devices of the Medical Device Rules, 2017 \u2013 the\nCDSCO has added a new section which sets the <strong>new registration for the manufacturers<\/strong> wherein the required certifications\nand documentation shall be uploaded for regulatory reviewing through an online\nportal.<\/li><li>The medical devices at present\nnotified under the Medical Device Rules, 2017 will not meet the criteria for\nthe Chapter IIIA registration option. It suggests that new route could be an\noption for the products that shall be notified in April under the amendment\nextension of medical device in India. The devices that are entered into market via\nthis expedited route will be exempted from the other requirements of the\nMedical Device Rules, 2017.<\/li><li>The registration under Chapter\nIIIA shall be voluntary for 18 months abiding with the extension of medical\ndevice route implementation.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"_Conclusion\"><\/span>&nbsp;Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Any violation of Medical Devices Rules that also includes the failure to obtain license or registration before the fixed deadline shall result in to criminal prosecution which can either be imprisonment or fine or both. Also such stocks of medical device sold without license or registration could be confiscated.  <\/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>This year was the most important year for the medical device companies from the perspective of the medical devices and the regulations since the Medical Device Rules, 2017 has came into force on January 01, 2018. The Government has planned to amend the regulations for medical devices to considerably expand the medical device regulations reach. [&hellip;]<\/p>\n","protected":false},"author":33,"featured_media":29546,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[1701],"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":5366,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29528"}],"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=29528"}],"version-history":[{"count":8,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29528\/revisions"}],"predecessor-version":[{"id":29548,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/29528\/revisions\/29548"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/29546"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=29528"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=29528"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=29528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}