{"id":43514,"date":"2022-05-20T12:59:06","date_gmt":"2022-05-20T07:29:06","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=43514"},"modified":"2022-05-20T12:59:54","modified_gmt":"2022-05-20T07:29:54","slug":"cdsco-guidelines-for-medical-device-import","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-guidelines-for-medical-device-import\/","title":{"rendered":"CDSCO Guidelines for Medical Device Import"},"content":{"rendered":"\n<p class=\"has-drop-cap\"><strong>The Central Drugs\nStandard Control Organization (CDSCO) is<\/strong> a National Regulatory Authority <strong>operating under<\/strong>\nthe Directorate General of Health Services, Ministry of Health &amp; Family Welfare,\nGovernment of India. Medical devices are freely imported into India. To ensure\nthe quality of the product being imported into the country Government of India\nhas developed regulations and guidelines. The guidelines are applicable\nwhen one wants to import medical devices from outside India. The devices are\nclassified as per the CDSCO guideline. There is a list of CDSCO notified\ndevices and has provided a complete procedure for import of medical devices\nin-country. <\/p>\n\n\n\n<p>Medical devices entering into Indian Market must be in compliance with guidelines set forth by the CDSCO. CDSCO is solely responsible for all clinical and new drug trials in India as an import license is to import medical device from another country, so overseas company and Indian company both needs to submit a document for Medical Device and manufacturing unit.<\/p>\n\n\n\n<p>All medical devices imported into India <a href=\"https:\/\/corpbiz.io\/cdsco-medical-device-import-license\"><strong>CDSCO Medical Device Import License<\/strong><\/a> required. If any medical devices are imported into India without getting Registration, it will be considered a violation of Indian law and thereby invite penalty for same. <\/p>\n\n\n\n<p>There was an amendment\nin Medical Device Rule 2017 in February 2020 referred to as &#8220;Medical\nDevices (Amendment) Rules 2020. As per the amendment, all the medical devices\nimported to India before October 2021 require Registration. For the\nRegistration, importers of Medical device or equipment has to register\nthemselves with the Central Standard Control Organization (CDSCO) <\/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-guidelines-for-medical-device-import\/#Application_as_per_CDSCO_guidelines\" >Application\nas per 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-guidelines-for-medical-device-import\/#Whether_Components_and_accessories_imported_also_require_Registration_as_per_CDSCO_Guidelines\" >Whether\nComponents and accessories imported also require Registration as per CDSCO\nGuidelines?<\/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-guidelines-for-medical-device-import\/#Consequences_of_Non-Registration_as_Per_CDSCO_Guidelines\" >Consequences\nof Non-Registration as Per CDSCO Guidelines<\/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-guidelines-for-medical-device-import\/#Test_license_for_import\" >Test\nlicense for import<\/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-guidelines-for-medical-device-import\/#Duration_of_License_granted\" >Duration\nof License granted<\/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-guidelines-for-medical-device-import\/#Renewal_of_License\" >Renewal\nof License<\/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-guidelines-for-medical-device-import\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_as_per_CDSCO_guidelines\"><\/span>Application\nas per CDSCO guidelines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>An\nAuthorized agent having a valid license to manufacture for sale or distribution\nor wholesale License for same can apply for an application for grant of import\nLicense for Medical Device to the central licensing authority online in form\nMD14 on the portal of Ministry of Health and Family Welfare for obtaining a\nlicense. <\/li><li>If\nthe central Licensing authority has a reason to believe that the quality of the\nmedical device has been compromised, then it is subjected to go through the\ntest &amp; evaluation in the testing laboratory as specified by the Central\nLicensing Authority. <\/li><li>After\nevaluation of the application form and documents, if the central licensing\nauthority is satisfied, it will grant a License to import in form MD 15. If the\nauthority is not satisfied, it may reject the application, and the reason for\nrejection is required to be recorded in writing within nine months from the\ndate of application. <\/li><li>If\nthe application is rejected, an applicant can make an appeal to the Central\nGovernment within forty-five days from the date of rejection and the\nGovernment, after an enquiry in this matter, pass an order in relation there\nwithin ninety days from the date of appeal. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Whether_Components_and_accessories_imported_also_require_Registration_as_per_CDSCO_Guidelines\"><\/span>Whether\nComponents and accessories imported also require Registration as per CDSCO\nGuidelines? <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per CDSCO, components and accessories imported\nneed not be registered separately. However, what separately means is not clear.\nAll components and accessories should be registered because, in the\nregistration form, details of components and accessories are required to be\nfilled if any components and accessories are not registered as Medical Device\nfor some reason, then they need to be registered as &#8216;Medical Device&#8217; as per the\ndefinition of Medical Device mentioned in the Act. <\/p>\n\n\n\n<p>Documents required for Registration are AN ISO 13485\ncertificate, a certificate to Foreign Government or Free Sale Certificate and\nan undertaking stating that the information and documents submitted are true to\ntheir knowledge and are authentic.\n<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Consequences_of_Non-Registration_as_Per_CDSCO_Guidelines\"><\/span>Consequences\nof Non-Registration as Per CDSCO Guidelines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A device which is required to be registered cannot\nbe imported into India without Registration after October 1, 2021. The\nimporters need to get Registration done before they import medical devices to\nIndia. <\/p>\n\n\n\n<p>Devices imported after October 1, 2021, if not registered,\nwill invite penal action under The Drugs and Cosmetics Act, 1940. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Test_license_for_import\"><\/span>Test\nlicense for import <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Test License is for the import of a small amount of drug or small quantity of medical device, which is prohibited under section 10 of the Drugs and Cosmetics Act and Rules 1945, for the purpose of examination, evaluation or analysis. <\/p>\n\n\n\n<p>For the import of new drugs for testing or clinical\ntrials, form 11 is required to be filled.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Procedure\nfor obtaining Form 11 as per CDSCO guidelines for Medical Device import <\/h3>\n\n\n\n<p>An application is required to be made in Form 12 for\nobtaining a License under Form 11. Since 1<sup>st<\/sup> April 2016, all\napplications should be made through the CDSCO&#8217;s SUGAM portal. <\/p>\n\n\n\n<p>Following are the condition which the applicant must consider as per Rule 33 of the <strong>Drugs and Cosmetics Act<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Acts-Rules\/\"><strong>[1]<\/strong><\/a><\/sup>, <\/p>\n\n\n\n<ul><li>No\ndrug should be imported for commercial use <\/li><li>Substances\nimported for evaluation must be that substance only for which a license is to\nbe granted. <\/li><li>The\npremises used for evaluation must be made available for inspection with or\nwithout notice by licensing authority authorized by the Central licensing\nauthority. <\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Documents required <\/h3>\n\n\n\n<ul><li>Covering\nLetter <\/li><li>Form\n12<\/li><li>TR6\nChallan utilization<\/li><li>Testing\nprotocol <\/li><li>Product\nlabels and brochures <\/li><li>FSC\n( Free Sale Certificate ) in the country of origin <\/li><li>Legal\nagreement<\/li><li>Approval\nby Ethics committee&nbsp; <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Duration_of_License_granted\"><\/span>Duration\nof License granted<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A license is valid for five years from the date of\nits issue.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renewal_of_License\"><\/span>Renewal\nof License <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Applicant needs to apply for renewal of License in\nForm 11 with all important documents and challan. The Renewal of License is not\navailable for Test License. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ever since the increasing demand for import and export of medical device from India, Government has been coming up with new policies to make such process easy and smooth. The Registration for import of Medical devices is mandatory to process, and it must strictly be as per Central Drugs standard control organization.\u00a0 <\/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\/medical-device-and-ivd-emergency-in-india\/\">Medical Device and IVD Emergency in India\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drugs Standard Control Organization (CDSCO) is a National Regulatory Authority operating under the Directorate General of Health Services, Ministry of Health &amp; Family Welfare, Government of India. Medical devices are freely imported into India. To ensure the quality of the product being imported into the country Government of India has developed regulations and [&hellip;]<\/p>\n","protected":false},"author":38,"featured_media":43520,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2359],"acf":{"service_id":"508"},"authorName":"Srishti Pandey","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-13.jpg","authorDescription":"She holds degree in B.COM, LLB (Delhi University), LLM (NLU, Delhi) and is also NET Qualified. She has previously worked as an Assistant Professor of Law in renowned university. She has a keen interest in writing on legal topics using academic and professional acumen.","postViews":4932,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43514"}],"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\/38"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=43514"}],"version-history":[{"count":24,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43514\/revisions"}],"predecessor-version":[{"id":43547,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43514\/revisions\/43547"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/43520"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=43514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=43514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=43514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}