{"id":49711,"date":"2022-10-06T12:05:39","date_gmt":"2022-10-06T06:35:39","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49711"},"modified":"2025-10-08T17:49:14","modified_gmt":"2025-10-08T12:19:14","slug":"cdsco-medical-device-registration-for-ivd-lab-kits","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-ivd-lab-kits\/","title":{"rendered":"How to Get CDSCO Medical Device Registration for IVD Lab Kits?"},"content":{"rendered":"\n<p>In India, In-Vitro Diagnostic (IVD) kits are regulated under the Drugs and Cosmetics Act 1940 &amp; Rules 1945. In-Vitro Diagnostic products are those intended for or in use in diagnosing disorders, diseases and infections in human beings or animals. IVDs are considered as \u201cDrugs\u201d in the Indian regulatory framework as defined under Section 3 (b) (i) of the Drugs &amp; Cosmetic Act 1940. The diagnostic kits\/reagents have been classified as non-notified and notified. The present Indian regulation also has a list of 22 notified medical devices under the Central Drugs Standard Control Organization (CDSCO). This blog will discuss CDSCO <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Device Registration<\/strong><\/a> for IVD Lab Kits.<\/p>\n\n\n\n<p><strong><em>Following\nIVD Lab kits are notified under the Drugs and Cosmetic Act 1940:<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>In-Vitro Diagnostic Devices for HIV<\/li>\n\n\n\n<li>In-Vitro Diagnostic Devices for HBV<\/li>\n\n\n\n<li>In-Vitro Diagnostic Devices for HCV<\/li>\n\n\n\n<li>In-Vitro Blood grouping sera<\/li>\n<\/ul>\n\n\n\n<p>All In-Vitro\nDiagnostic Lab kits, excluding those listed under Notified category, would be\ncovered under Non-Notified IVD products. <\/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-medical-device-registration-for-ivd-lab-kits\/#What_are_IVD_Lab_Kits\" >What are IVD Lab Kits?<\/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-medical-device-registration-for-ivd-lab-kits\/#Important_Regulatory_Bodies_for_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits_in_India\" >Important Regulatory Bodies for\nCDSCO Medical Device Registration for IVD Lab Kits in India<\/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-medical-device-registration-for-ivd-lab-kits\/#Risk-Based_Classifications_for_Medical_Devices\" >Risk-Based Classifications for\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\/cdsco-medical-device-registration-for-ivd-lab-kits\/#Required_Documents_for_Getting_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\" >Required Documents for Getting\nCDSCO Medical Device Registration for IVD Lab Kits<\/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-medical-device-registration-for-ivd-lab-kits\/#Procedure_to_Get_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\" >Procedure to Get CDSCO Medical\nDevice Registration for IVD Lab Kits<\/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\/cdsco-medical-device-registration-for-ivd-lab-kits\/#Renewal_Process_of_the_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\" >Renewal Process of the CDSCO\nMedical Device Registration for IVD Lab Kits<\/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\/cdsco-medical-device-registration-for-ivd-lab-kits\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_IVD_Lab_Kits\"><\/span>What are IVD Lab Kits?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In-Vitro Diagnostics\n(IVDs) are tests that can identify diseases, disorders, and infections. In\nvitro, which means &#8220;in glass,&#8221; means these tests are frequently\ncarried out in test tubes &amp; other similar apparatus or tools as opposed to\nin vivo testing, which are carried out inside the body. In-Vitro tests may be\ndone in labs, hospitals, or even individuals&#8217; homes. The tests themselves can\nbe performed on a variety of instruments ranging from small, handheld tests to\ncomplex lab instruments. They enable medical professionals to diagnose patients\naccurately and pursue the most effective treatments. This is especially true in\nprimary healthcare settings in low-income and middle-income nations. A wide\nrange of IVDs is accessible for patient testing in the primary care setting\nwhere laboratories are unavailable, which frequently lack an integrated network\nof laboratories for such diagnoses. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Regulatory_Bodies_for_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits_in_India\"><\/span>Important Regulatory Bodies for\nCDSCO Medical Device Registration for IVD Lab Kits in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li><strong>The Drugs &amp; Cosmetic Act &amp; Rules:<\/strong> These rules regulate the manufacture, import, and distribution of Drugs &amp; medical devices in India.<\/li>\n\n\n\n<li><strong>CDSCO<\/strong> is the regulatory body in India, under the <strong>Directorate General of Health Services (DGHS<\/strong>) and Ministry of Health &amp; Family Welfare which regulates medical devices and drugs.<\/li>\n\n\n\n<li><strong>DCGI<\/strong> is the head of the CDSCO and is liable for approving quality drugs, cosmetics, and medical devices sold in India and regulating clinical trials.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk-Based_Classifications_for_Medical_Devices\"><\/span>Risk-Based Classifications for\nMedical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical devices have been classified into various categories depending on risk-based:<\/p>\n\n\n\n<ul>\n<li>Class A: <strong>Low<\/strong><\/li>\n\n\n\n<li>Class B: <strong>Moderate\nLow<\/strong><\/li>\n\n\n\n<li>Class C: <strong>Moderate-High<\/strong><\/li>\n\n\n\n<li>Class D: <strong>High<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Required_Documents_for_Getting_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\"><\/span>Required Documents for Getting\nCDSCO Medical Device Registration for IVD Lab Kits<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are the vital Documents required in obtaining CDSCO Medical Device Registration for IVD Lab Kits:<\/p>\n\n\n\n<ul>\n<li>Power of Attorney;<\/li>\n\n\n\n<li>Schedule DI;<\/li>\n\n\n\n<li>Schedule DII;<\/li>\n\n\n\n<li>Details according to Annexure B (HIV, HBV, HCV,\nand Blood Grouping Sara) of Schedule DII;<\/li>\n\n\n\n<li>TR6 Challan;<\/li>\n\n\n\n<li><strong><a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\">Whole Sale Drug License<\/a><\/strong>;<\/li>\n\n\n\n<li>Quality management system certificate (ISO\n13485);<\/li>\n\n\n\n<li>CE Design Certificate (if applicable);<\/li>\n\n\n\n<li>Complete Quality Assurance Certificate or CE\nProduction Quality Assurance Certificate or CE Type Examination Certificate or\nCE Product Quality Assurance;<\/li>\n\n\n\n<li>Declaration of Company;<\/li>\n\n\n\n<li>Plant Master File;<\/li>\n\n\n\n<li>FSC viz USA, EU, Japan, Canada, Australia;<\/li>\n\n\n\n<li>Device Master File;<\/li>\n\n\n\n<li>PMS Study Report;<\/li>\n\n\n\n<li>Performance Evaluation Report of Products;<\/li>\n\n\n\n<li>PMS Study Report;<\/li>\n\n\n\n<li>The evaluation report is information conducted\nby the National Control Authority (NCA) of the Country of origin in respect of\nthree consecutive batches of proposed kits. In case the evaluation report from\nNCA is not available, then an evaluation or batch release report from the\nauthorised notified body may also be accepted;<\/li>\n\n\n\n<li>Information of AEs\/SAEs\/Recall\/Death\/Complaints\nof the proposed products reported globally and protocol for the investigation\nof root cause &amp; CAPA taken by the manufacturer (if any);<\/li>\n\n\n\n<li>Original labels and pack sizes;<\/li>\n\n\n\n<li>Product inserts.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Get_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\"><\/span>Procedure to Get CDSCO Medical\nDevice Registration for IVD Lab Kits<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO Medical Device Registration for IVD Lab Kits is an entirely online process. Following are the steps for obtaining <strong><a href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO Registration<\/a><\/strong> under the online portal of CDSCO:<\/p>\n\n\n\n<p><strong>Step 1:<\/strong> First, the applicant has to\nvisit the CDSCO Registration portal.<\/p>\n\n\n\n<p><strong>Step 2:<\/strong> To apply for registration, the\napplicant must go to the Registration page.<\/p>\n\n\n\n<p><strong>Step 3:<\/strong> Once the applicant opens the\nApplication Registration page, fill out all the vital details provided in the\napplication.<\/p>\n\n\n\n<p><strong>Step 4:<\/strong> Fill out the Registered Indian\nAddress Form containing information or details.<\/p>\n\n\n\n<p><strong>Step 5:<\/strong> Once the applicant applies\ncorrectly, an applicant will get a confirmation link to the applicant\u2019s\nregistered email id to verify the CDSCO Medical Device Registration. Then, the\napplicant must click on the link to activate the applicant account on the\nonline CDSCO Sugam portal.<\/p>\n\n\n\n<p><strong>Step 6:<\/strong> After clicking the confirmation\nlink, the CDSCO Registration application will be sent to the concerned\nauthority for approval.<\/p>\n\n\n\n<p><strong>Step 7:<\/strong> Once the CDSCO Medical Device\nRegistration application is approved, an approval email will be sent to the\napplicant&#8217;s registered email id. If the application is not approved, an email\nfor rejection will be sent to an applicant&#8217;s email id. Once the applicant gets\nthe approval mail, the applicant&#8217;s CDSCO Medical Device Registration will be\ncompleted.<\/p>\n\n\n\n<p><strong><em>Note:\nRegistering a medical device takes around 6 to 9 months. Unless an examination\nis required through the Subject Expert Committee\/Technical Presentation, the\nregistration process is extended by 3 to 6 months<\/em><\/strong> <strong><em>if these are important<\/em><\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renewal_Process_of_the_CDSCO_Medical_Device_Registration_for_IVD_Lab_Kits\"><\/span>Renewal Process of the CDSCO\nMedical Device Registration for IVD Lab Kits<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The application\nfor renewal of CDSCO medical device registration shall be made at least nine\nmonths before the expiry of the CDSCO medical device registration. There are no\nadditional requirements for the registration renewal process. It will be\nessential for the certificate holder to provide a copy of the Plant Master File\n(PMF) and Device Master File (DMF), where there is no change in the DMF and\nPMF.<\/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>CDSCO is constantly working to improve its services trenchancy, safety, accountability, and regularity to guarantee the promptness, potency, and quality of the medical device products produced, imported and distributed in India. In conclusion, it is suitable to conclude that CDSCO Medical Device Registration provides the public interest priority.  <\/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\/cdsco-registration-for-rheumatology-medical-devices\/\">CDSCO Registration for Rheumatology Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, In-Vitro Diagnostic (IVD) kits are regulated under the Drugs and Cosmetics Act 1940 &amp; Rules 1945. In-Vitro Diagnostic products are those intended for or in use in diagnosing disorders, diseases and infections in human beings or animals. IVDs are considered as \u201cDrugs\u201d in the Indian regulatory framework as defined under Section 3 (b) [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":49720,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2767],"acf":{"service_id":"508"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":3067,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49711"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=49711"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49711\/revisions"}],"predecessor-version":[{"id":70175,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49711\/revisions\/70175"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49720"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}