{"id":45471,"date":"2022-07-19T11:16:26","date_gmt":"2022-07-19T05:46:26","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=45471"},"modified":"2022-07-19T11:16:28","modified_gmt":"2022-07-19T05:46:28","slug":"notification-for-non-notified-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/notification-for-non-notified-medical-devices\/","title":{"rendered":"Notification for Non-Notified Medical Devices"},"content":{"rendered":"\n<p>On 11<sup>th<\/sup> July 2022. in regard to the prior notification issued on 11<sup>th<\/sup> February 2020, \u201cNotification No. G.S.R. 102 (E)\u201d, the Central Drugs Standard Control Organisation, which is also known as CDSCO, has directed in India for all medical devices that fall under the category of Class A and Class B have to obtain Licensing mandatorily which is to come into effect from 1st October 2022. This is a Notification on Non-Notified Medical Devices where it is mandated for the Class and Class B Medical Products to apply for the issuance of a license under the CDSCO Licensing Authority in accordance with the Medical Devices Rules, 2017, which is also known as the MDR 2017.<\/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\/notification-for-non-notified-medical-devices\/#What_are_the_Non-Notified_Medical_Devices\" >What are the 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-2\" href=\"https:\/\/corpbiz.io\/learning\/notification-for-non-notified-medical-devices\/#Transition_Period_for_Non-Notified_Medical_Devices\" >Transition\nPeriod for Non-Notified 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\/notification-for-non-notified-medical-devices\/#Compliance_Measures_for_Non-Notified_Medical_Devices\" >Compliance Measures for Non-Notified\nMedical 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\/notification-for-non-notified-medical-devices\/#Filling_Procedure_Measures_for_Non-Notified_Medical_Devices\" >Filling Procedure Measures for Non-Notified\nMedical 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\/notification-for-non-notified-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Non-Notified_Medical_Devices\"><\/span>What are the Non-Notified Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>The following devices mentioned below are the\nNon-Notified Medical Devices that are mandated to be registered by CDSCO &#8211;<\/li><li>Anesthesiology Medical Devices<\/li><li>Pain Management Medical Devices<\/li><li>Cardiovascular Medical Devices<\/li><li>Dental Medical Devices<\/li><li>Ear, Nose, Throat Treatment Medical Devices,\nwhich is also referred to as ENT Treatment Medical Devices<\/li><li>Gastroenterological Medical Devices<\/li><li>Urological Medical Devices<\/li><li>Operation Theatre Medical Devices, which is also\nreferred to as OT Medical Devices<\/li><li>Respiratory Medical Devices<\/li><li>Neurology Medical Devices<\/li><li>Personnel Use Medical Devices<\/li><li>Obstetrical and Gynaecological Medical Devices,\nwhich is also referred to as OG Medical\nDevices<\/li><li>Ophthalmology\nMedical Devices<\/li><li>Rehabilitation\nMedical Devices<\/li><li>Physical\nSupport Medical Devices<\/li><li>Interventional\nand Radiology Medical Devices<\/li><li>Rheumatology\nMedical Devices<\/li><li>Dermatology\nand Plastic Surgery Medical Devices<\/li><li>Pediatric\nand Neonatology Medical Devices<\/li><li>Oncology\nMedical Devices<\/li><li>&nbsp;Radiotherapy Medical Devices<\/li><li>Nephrology\nand Renal Care Medical Devices<\/li><li>Software\nMedical Devices<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Transition_Period_for_Non-Notified_Medical_Devices\"><\/span>Transition\nPeriod for Non-Notified Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO provided a \u201cTransition Period\u201d of Thirty Months for Class A and Class B Medical Devices to be counted from the date of implementation, where the Notification on Non-Notified Medical Devices stated that the producers are mandated to register their medical devices for licensing under CDSCO and to mandatorily label their granted <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration <\/strong><\/a>Number in each medical Device.<\/p>\n\n\n\n<p>For Medical Devices that fall under Class C and Class D are\nmandated to apply for licensing and are provided with the \u201cTransition Period\u201d\nof forty-two months to be counted from the date of the notification, i.e., 1<sup>st<\/sup>\nApril 2020.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Compliance_Measures_for_Non-Notified_Medical_Devices\"><\/span>Compliance Measures for Non-Notified\nMedical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To avoid confusion in regard to other\nentities providing Quality Assurance Certificates to Medical Devices that do\nnot necessarily follow the compliance measures for each Regulation specified in\nMedical Devices Rules 2107, the CDSCO has declared for the License that is\nissued by their Regulatory Authority is deemed valid and no other Certificates\nor Licenses issued by any other entity is to act as a replacement of the CDSCO\nLicense. All producers of Medical Devices need to mandatorily comply with\nmeeting the Requirements set by CDSCO for Licensing and have to be in\naccordance with the Medical Devices Rules, 2017.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Filling_Procedure_Measures_for_Non-Notified_Medical_Devices\"><\/span>Filling Procedure Measures for Non-Notified\nMedical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The manufacturers of Class A and Class B\nmedical devices are also required to apply for the CDSCO License under the\napplicable State Licensing Authority. Upon submission of the application and the\nnecessary required documents, the CDSCO evaluates the documents and conducts Audits\nas per the requirement within the prescribed time in accordance with the\nMedical Devices Rules, 2017.<\/p>\n\n\n\n<p>A\nparticular Notification was issued on 25<sup>th<\/sup> April 2022 by the CDSCO,\nwhere it stated that to avoid any further delay, the CDSCO has advised the\nState Licensing Authorities to immediately issue Application Forms drafted in\naccordance with the Medical Devices Rules, 2017. <\/p>\n\n\n\n<p>On 1<sup>st<\/sup> April 2020, the producers of Medical Devices were instructed to mandatorily submit the \u201cCertificate of Compliance\u201d in accordance with ISO 13485 Standards which are attributed by the <strong>National Accreditation Board for Certification Bodies<\/strong><sup><a href=\"https:\/\/nabcb.qci.org.in\/\/\"><strong>[1]<\/strong><\/a><\/sup> or International Accreditation Forum for the Registration of the medical devices.<\/p>\n\n\n\n<p>The CDSCO also specifies the Manufacturing License issued in\naccordance with the Medical Devices Rules, 2017 depicts that the Medical Device\nis in Conformance with the Fifth Schedule, i.e., Quality Management System of\nMDR, 2017 and the Separate GMP\/QMS are prohibited from issuing any State Licencing\nAuthority or Central Licensing Authority in accordance with the Medical Devices\nRules, 2017.<\/p>\n\n\n\n<p>For the purpose of maintaining of Quality of the Components\nand Raw Materials while being manufactured, it is mandated that specific\ncomponents are required to be met for maintaining the standards of quality in\naccordance with the Quality Management System, ISO 13485. In case the products\nare being imported, the manufacturers need to also issue a \u201cFree Sale\nCertificate\u201d for the finished medical device product, which can be only\nimported into Global Harmonisation Task Force Countries, also known as GHTF\nCountries. The applicant is also mandated to submit the documentary evidence to\nthe licensing authority for the grant of the license. The CDSCO is to then\nconduct an audit or inspection as deemed necessary.<\/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>Prior to the issuance of the said notification, only Notified Medical Devices were applicable for registering for CDSCO License. However, now all medical devices are required to comply with the registration process for CDSCO Licensing along with the thirty-seven Notified 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\/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>On 11th July 2022. in regard to the prior notification issued on 11th February 2020, \u201cNotification No. G.S.R. 102 (E)\u201d, the Central Drugs Standard Control Organisation, which is also known as CDSCO, has directed in India for all medical devices that fall under the category of Class A and Class B have to obtain Licensing [&hellip;]<\/p>\n","protected":false},"author":37,"featured_media":45473,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2513],"acf":{"service_id":"385"},"authorName":"Sushree Dash","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-9.jpg","authorDescription":"Sushree Dash has completed BBA-LLB with a specialization in IPR Laws from KIIT University. As a recent graduate, she has both legal and management internship experience in international law firms, Indian law firms and under Indian litigation. She secures good drafting skills for various legal documents in multiple fields of law. She has also published multiple research papers in reputed UGC approved international journals.","postViews":3018,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45471"}],"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\/37"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=45471"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45471\/revisions"}],"predecessor-version":[{"id":45478,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/45471\/revisions\/45478"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/45473"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=45471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=45471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=45471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}