{"id":11768,"date":"2022-09-01T07:01:18","date_gmt":"2022-09-01T07:01:18","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11768"},"modified":"2022-09-01T07:03:40","modified_gmt":"2022-09-01T07:03:40","slug":"cdsco-approval-for-voluntary-registration-of-medical-devices","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/","title":{"rendered":"CDSCO Approval for Voluntary Registration of Medical Devices"},"content":{"rendered":"\n<p>In India, the regulation of medical devices\nis carried out by the Central Drugs Standard Control Organisation (CDSCO). The\ngovernment authority has enlisted around 37 medical devices as per the latest\nnotification. The CDSCO has made an amendment to the Medical device rules of\n2017. The amendment stated that stakeholders could make a voluntary\nregistration from February 11, 2020 &#8211; October 1, 2021. However, the CDSCO has\nextended this date by one year, and the new deadline is October 1, 2022.\nSuppose the manufacturer fails to obtain this registration before the deadline.\nIn that case, they shall not be allowed to do their business and face a\npotential risk of paying hefty fines until they complete the registration. In\nthis article, we shall explain CDSCO Approval for Voluntary Registration of\nMedical Devices.&nbsp; <\/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-6a3aca31b7a49\" 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-6a3aca31b7a49\"  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\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#The_necessity_of_CDSCO_Approval_for_Voluntary_Registration\" title=\"The necessity of CDSCO Approval for Voluntary Registration\">The necessity of CDSCO Approval for Voluntary Registration<\/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\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Entities_who_require_to_obtain_CDSCO_Approval_for_Voluntary_Registration\" title=\"Entities who require to obtain CDSCO Approval for\nVoluntary Registration\">Entities who require to obtain CDSCO Approval for\nVoluntary Registration<\/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\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Important_Documents_and_information_required_for_CDSCO_Approval_for_Voluntary_Registration\" title=\"Important Documents and information required for CDSCO\nApproval for Voluntary Registration\">Important Documents and information required for CDSCO\nApproval for Voluntary Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Process_of_CDSCO_Approval_for_Voluntary_Registration_of_medical_devices\" title=\"Process of CDSCO Approval for Voluntary Registration of medical devices\">Process of CDSCO Approval for Voluntary Registration of medical 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:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Consequences_of_the_Failure_to_obtain_CDSCO_Approval_for_Voluntary_Registration\" title=\"Consequences of the Failure to obtain CDSCO Approval for Voluntary Registration\">Consequences of the Failure to obtain CDSCO Approval for Voluntary Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Fee_charged_by_the_government_for_Voluntary_Registration\" title=\"Fee charged by the government for Voluntary Registration\">Fee charged by the government for Voluntary Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Validity_of_CDSCO_Approval_for_Voluntary_Registration\" title=\"Validity of CDSCO Approval for Voluntary Registration\">Validity of CDSCO Approval for Voluntary Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/swaritadvisors.com\/blog\/cdsco-approval-for-voluntary-registration-of-medical-devices\/#Conclusion\" title=\"Conclusion:\">Conclusion:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_necessity_of_CDSCO_Approval_for_Voluntary_Registration\"><\/span>The necessity of CDSCO Approval for Voluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Voluntary registration of the medical\ndevices just requires the manufacturer to obtain an ISO 13485. This shall be\ngranted by either International Accreditation Forum (IAF) or National\nAccreditation Board for Certification Bodies (NABCB). The government believes\nit is high time to regulate the medical device industry in the country. For\nthose reasons, it has not asked the manufacturers to produce safety past\neffectiveness data of the product. This move shall ensure that medical devices\nin the country meet the minimum requirement of ISO 13485 certification.<\/p>\n\n\n\n<p>Note: ISO 13485 is applied to the quality management system for designing and manufacturing a medical device.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Entities_who_require_to_obtain_CDSCO_Approval_for_Voluntary_Registration\"><\/span>Entities who require to obtain CDSCO Approval for\nVoluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following entities need to make an\napplication for CDSCO Approval for Voluntary Registration:<\/p>\n\n\n\n<ul><li>Importers<\/li><li>Sellers<\/li><li>Manufacturers<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Documents_and_information_required_for_CDSCO_Approval_for_Voluntary_Registration\"><\/span>Important Documents and information required for CDSCO\nApproval for Voluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The applicant must provide the following\ninformation for the <strong>CDSCO Approval<\/strong>\nfor Voluntary Registration:<\/p>\n\n\n\n<ul><li>ISO 13485 Certificate<\/li><li>Free sale certificate\/ Certificate to a foreign government (applicable to imported medical devices)<\/li><\/ul>\n\n\n\n<p>This certificate is issued by the government of the country where the device is manufactured. It acts as proof that the medical device in question is sold freely in the country\/ region.<\/p>\n\n\n\n<ul><li>Undertaking (stating the information furnished in the application is true and best to the knowledge of the applicant)<\/li><li>The manufacturer\u2019s details (this must include name. address, email id and mobile number)<\/li><li>Details of the Site ( name, address and contact information)<\/li><li>Type of  activity to be mentioned (import\/export)<\/li><li>The  Device Category (medical device\/ IVD)<\/li><li>Generic name of the product<\/li><li>Intended use of the device<\/li><li>Description of the product<\/li><li>Class of Medical Devices<\/li><li>Medical device category<\/li><li>The material used for construction<\/li><li>Dimensions of the device (if applicable)<\/li><li>Shelf life of the device<\/li><li>Conditions to be maintained for the storage of the device<\/li><li>Size of the package<\/li><li>Sterile or Non-sterile <\/li><li>Name of the brand (as per registration under the Trade Mark Act, 1999)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_of_CDSCO_Approval_for_Voluntary_Registration_of_medical_devices\"><\/span>Process of CDSCO Approval for Voluntary Registration of medical devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The voluntary registration is applicable\nonly to non- notified medical products. A stakeholder (importer, manufacturer,\nand seller) must comply with the following steps to obtain CDSCO approval for\nthe voluntary registration of medical devices.<\/p>\n\n\n\n<ol><li>The applicant must log in to the CDSCOs website and navigate to the registration page for voluntary registration.<\/li><li>Applicants need to click on the registration link provided on the website.<\/li><li>The applicant must have a functional email and mobile number in order to complete the registration process.<\/li><li>The portal shall verify the mobile number and email id. Once the verification is completed, the applicant shall be asked to provide the necessary details.<\/li><li>Next, the applicant must upload all the relevant documents as mentioned previously in this article.<\/li><li>Once the form is completed, the applicant shall be asked to verify the registration through an OTP received on the mobile number.<\/li><li>After the completion of the self-verification, the process of application to obtain CDSCO approval shall be completed.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Consequences_of_the_Failure_to_obtain_CDSCO_Approval_for_Voluntary_Registration\"><\/span>Consequences of the Failure to obtain CDSCO Approval for Voluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Every manufacturer, seller and importer of medical devices must obtain the CDSCO&#8217;s approval for voluntary registration. However, if the concerned stakeholders fail to complete the voluntary registration before the deadline, i.e. 22nd October 2022, then:<\/p>\n\n\n\n<ul><li>Entities without the registration shall be asked to stop their operations in the Indian market and;<\/li><li>These entities shall also be liable for penal action under the<strong> Drugs and Cosmetics Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Fee_charged_by_the_government_for_Voluntary_Registration\"><\/span>Fee charged by the government for Voluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As of now, there is no government fee applicable for the voluntary registration of medical devices under CDSCO.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_CDSCO_Approval_for_Voluntary_Registration\"><\/span>Validity of CDSCO Approval for Voluntary Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The voluntary license shall be valid till the manufacturer\/ importer\/ seller obtains a permanent<strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-manufacturing-licence\" class=\"text-primary\"> CDSCO License<\/a><\/strong>. <\/p>\n\n\n\n<ul><li>For Class A (low-risk) and Class B (low-medium risk) must obtain the license mandatorily before 30 September 2022<\/li><li>For Class C (moderate-high risk) and Class D (high risk) must obtain the license mandatorily before 30 September 2023<\/li><\/ul>\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 government has introduced CDSCO voluntary registration to ensure that good quality ISO-certified products are brought into the market. The voluntary registration shall extend to only non-notified devices and till the time manufacturers, importers or sellers receive their licenses. <\/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\/manufacturing-registration-for-cdsco-medical-devices\/\">Manufacturing Registration for CDSCO Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, the regulation of medical devices is carried out by the Central Drugs Standard Control Organisation (CDSCO). The government authority has enlisted around 37 medical devices as per the latest notification. The CDSCO has made an amendment to the Medical device rules of 2017. The amendment stated that stakeholders could make a voluntary registration [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11769,"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\/11768"}],"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=11768"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11768\/revisions"}],"predecessor-version":[{"id":11773,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11768\/revisions\/11773"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11769"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11768"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11768"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11768"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}