{"id":49371,"date":"2022-09-27T16:07:45","date_gmt":"2022-09-27T10:37:45","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49371"},"modified":"2022-09-27T16:21:46","modified_gmt":"2022-09-27T10:51:46","slug":"voluntary-registration-of-medical-device","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/voluntary-registration-of-medical-device\/","title":{"rendered":"Voluntary Registration of Medical Device &#8211; An Overview"},"content":{"rendered":"\n<p>As per the Ministry of Health &amp; Family Welfare, there has been a recent amendment in the <strong>Medical Device Rules, 2017<\/strong><sup><a href=\"https:\/\/www.dfda.goa.gov.in\/circulars-orders-notifications\/notification\/419-medical-device-rules-2017\"><strong>[1]<\/strong><\/a><\/sup>. The Official Gazette G.S.R. 102 (E) was made public on 11th February 2020. It notified that the medical devices must be registered with the Central Licensing Authorities via an online portal, which CDSCO regulates. The registration was voluntary only for eighteen months from the date of the notice. However, the deadline for Voluntary Registration of <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">Medical Device<\/a><\/strong> of Class A and B has been extended to 1st October 2022. Whereas the deadline for Voluntary Registration of Medical Device of Class C and D has been extended to 1st October 2023. <\/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\/voluntary-registration-of-medical-device\/#Overview_of_Medical_Device_Rules_2017\" >Overview of Medical Device Rules, 2017<\/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\/voluntary-registration-of-medical-device\/#Documents_Required_for_Voluntary_Registration_of_Medical_Device\" >Documents Required for Voluntary Registration of Medical Device<\/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\/voluntary-registration-of-medical-device\/#Procedure_for_Voluntary_Registration_of_Medical_Device\" >Procedure for Voluntary Registration of Medical 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\/voluntary-registration-of-medical-device\/#Time_period_and_validity_of_Voluntary_Registration_of_Medical_Device\" >Time period and validity of Voluntary Registration of Medical Device<\/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\/voluntary-registration-of-medical-device\/#Rejection_of_Voluntary_Registration_of_Medical_Device\" >Rejection of Voluntary Registration of Medical Device<\/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\/voluntary-registration-of-medical-device\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Medical_Device_Rules_2017\"><\/span>Overview of Medical Device Rules, 2017 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central\nDrugs Standard Control Organization or CDSCO is the highest regulatory body in\nIndia that monitors Medical Device regulations. CDSCO is responsible for\napproving licences to import and manufacture medical devices in India. The\nMedical Device Rules, 2017 were notified by the CDSCO to regulate the import,\nsale, distribution, production, and clinical trials, among other things.\nAdditionally, the medical devices have been divided into four classes based on\nthe risk associated with each device. The following is the classification of\nmedical devices based on risk:<\/p>\n\n\n\n<ul><li>Class A medical devices- Low-Risk <\/li><\/ul>\n\n\n\n<ul><li>Class B medical devices &#8211; Low- Medium Risk <\/li><\/ul>\n\n\n\n<ul><li>Class C medical devices &#8211; Medium- High-Risk<\/li><\/ul>\n\n\n\n<ul><li>Class D medical devices &#8211; High-Risk<\/li><\/ul>\n\n\n\n<p><strong><em>On 11.02.2020, the Central Government issued two notifications-<\/em><\/strong><\/p>\n\n\n\n<ul><li> S.O. 648(E) -New definition of medical devices <\/li><\/ul>\n\n\n\n<ul><li>GSR 102(E) &#8211; The Medical Devices (Amendment) Rules, 2020, amending the Medical Devices Rules, 2017. It has become effective from 1st April 2020<\/li><\/ul>\n\n\n\n<p>The Central Government widened the scope of the definition of\nMedical Devices vide its notification dated 11.02.2020, effective from\n01.04.2020.<\/p>\n\n\n\n<p>According to the new S.O. 648(E), from 1st April 2020, all\nmedical devices, comprising all apparatus, material, or appliance, etc. for any\nintended purpose, invasive\/non-invasive, used directly\/indirectly in\nhuman\/animal, has been included under the definition of Medical Devices. Until\n11th February 2020, only 37 categories of medical devices were regulated or\nnotified as drugs.<\/p>\n\n\n\n<p>The second notification issued on 11.02.2020 was GSR 102(E)\namending the Medical Devices Rules 2017. According to it, the manufacturers or\nimporters of Medical Devices will be required to compulsorily register their\nmedical devices with the DCGI. The DCGI will begin accepting applications for\nregistration via a dedicated online portal called &#8216;Online System for Medical\nDevices&#8217; (established by Central Drugs Standard Control Organisation) on 1st\nApril 2020. Suppose an importer or manufacturer cannot obtain registration for\ntheir medical device before the given timeline. They will not be able to market\nand sell their medical device in India until registration is received.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_Voluntary_Registration_of_Medical_Device\"><\/span><strong>Documents Required for Voluntary Registration of Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents which must be uploaded on the portal by the Manufacturer for Voluntary Registration of Medical Device are as follows-<\/p>\n\n\n\n<ul>\n<li>Name and Address of the company, firm or manufacturing site<\/li>\n<li>Details of the medical device, such as-<\/li>\n<\/ul>\n<ol style=\"list-style-type: upper-alpha;\">\n<li>&nbsp;Generic Name<\/li>\n<li>Brand Name<\/li>\n<li>Model no.<\/li>\n<li>Intended use<\/li>\n<li>Class of medical device<\/li>\n<li>Material of Construction<\/li>\n<li>Dimension<\/li>\n<li>Shelf life<\/li>\n<li>Sterile or non-sterile<\/li>\n<\/ol>\n<ul>\n<li>Certificate of compliance with ISO 13485 standard for such medical device, accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum<\/li>\n<li>Undertaking signed by the manufacturer specifying that the information furnished by the applicant is genuine and authentic.<\/li>\n<\/ul>\n\n\n\n<p><strong>The documents which must be uploaded on the portal by the Importers for Voluntary Registration of Medical Device are as follows-<\/strong><\/p>\n\n\n\n<ol><li>Name of the company, firm or any entity importing the medical device<\/li><li>Details of the medical device, such as-<\/li><\/ol>\n\n\n\n<ul><li>Generic Name <\/li><li>Brand Name&nbsp; <\/li><li>Model no.<\/li><li>Intended use<\/li><li>Class of medical device <\/li><li>Material of Construction<\/li><li> Dimension &nbsp;<\/li><li>Shelf life <\/li><li>Sterile or non-sterile <\/li><\/ul>\n\n\n\n<p>3. Certificate of compliance with ISO 13485 standard for such medical device, accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.<\/p>\n\n\n\n<p>4. Free Sale Certificate from Country of Origin.<\/p>\n\n\n\n<p>5. An undertaking from the importer that the applicant&#8217;s information is accurate and true.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Voluntary_Registration_of_Medical_Device\"><\/span><strong>Procedure for Voluntary Registration of Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to Rule 19C and 19E of Chapter IIIA of the Medical\nDevices (Amendment) Rules, 2020, the manufacturer or importer must upload the\nrequired documents on the online portal. CDSCO will then generate the\nregistration number for the medical device. After furnishing the details\nuploaded on the &#8220;Online System for Medical Devices&#8221;, The Manufacturer\nand Importer shall receive the registration. They must also mention the\nobtained registration number on the device&#8217;s label. <\/p>\n\n\n\n<p>The procedure of voluntary registration can be followed only\nfor non-notified medical devices. The applicant must follow the following\nprocedure for Voluntary Registration of Medical Device-<\/p>\n\n\n\n<ol><li>The applicant must first visit the online portal on the official CDCSO website<\/li><li>Next, the applicant must click on the registration link from the portal to proceed<\/li><li>Upon clicking the link, the applicant must then register their Name, Email ID and Mobile number<\/li><li>After that, the applicant must upload the following documents-<\/li><\/ol>\n\n\n\n<ul><li>I.D. proof <\/li><li>Undertaking<\/li><li>Corporate Address Proof Details (Certificate of Incorporation of the company)<\/li><li>Copy of Manufacturing and Wholesale License <\/li><\/ul>\n\n\n\n<p>5.&nbsp;After uploading the details, the applicant shall be required to verify the registration through a 4-digit OTP received on the registered mobile number <\/p>\n\n\n\n<p>6.&nbsp;After registration, the applicant will be able to login into the account<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_period_and_validity_of_Voluntary_Registration_of_Medical_Device\"><\/span><strong>Time period and validity of Voluntary Registration of Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Per the guidance\ndocument published by CDSCO on 21st September 2021, the time validity of\nVoluntary Registration of Class A and B medical devices will be till 30th\nSeptember 2022. From 1st October 2022, class A and B medical device\nregistration will be mandatory. Class A and B device registration is first\nvoluntary for 18 months; then, it will be required for 12 months. The time\nvalidity of voluntary registration for class C and D medical devices will be\ntill 30th September 2023. From 1st October 2023, registration will be made\nmandatory. After 18 months of voluntary registration, The manufacturers or\nimporters must register Class C and D devices for 24 months.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Rejection_of_Voluntary_Registration_of_Medical_Device\"><\/span><strong>Rejection of Voluntary Registration of Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After giving the registrant the chance to explain why their\nregistration should not be rejected or suspended, the Central Licensing\nAuthority may cancel or suspend the registration number for a specific time.\nThis could happen if the registrant fails to meet the rules&#8217; requirements. The\nCLA can also check the document at any time to look into the issue. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p> The government has notified in an official notice regarding voluntary registration for medical devices to ensure that good quality and standards of products are introduced to the market. The voluntary registration shall apply to non-notified medical devices till the officially announced deadline. After the deadline is crossed, all medical devices shall fall into the category of mandatory registration. <\/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\/rules-relating-to-predicate-device-under-mdr-2017\/\">Rules Relating to Predicate Device under MDR, 2017<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As per the Ministry of Health &amp; Family Welfare, there has been a recent amendment in the Medical Device Rules, 2017[1]. The Official Gazette G.S.R. 102 (E) was made public on 11th February 2020. It notified that the medical devices must be registered with the Central Licensing Authorities via an online portal, which CDSCO regulates. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":49374,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2745],"acf":{"service_id":"385"},"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":4477,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49371"}],"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=49371"}],"version-history":[{"count":23,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49371\/revisions"}],"predecessor-version":[{"id":49396,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49371\/revisions\/49396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49374"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49371"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49371"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}