{"id":12242,"date":"2022-10-28T06:44:41","date_gmt":"2022-10-28T06:44:41","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=12242"},"modified":"2022-10-28T06:44:43","modified_gmt":"2022-10-28T06:44:43","slug":"grant-of-test-license-for-import-under-mdr-2017","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/grant-of-test-license-for-import-under-mdr-2017\/","title":{"rendered":"An Overview of Grant of Test License for Import under MDR, 2017"},"content":{"rendered":"\n<p>As per <strong><em>Section 40 of the MDR, 2017<\/em><\/strong>, any type of medical device or in-vitro diagnostic medical device may be imported to run any type of training testing, clinical investigation, etc. An individual (importer or manufacturer) who wants to import the medical devices of Class A, B, C, or D to India can get a Test License for Import under MDR, 2017, by <strong><em>Form MD-17<\/em><\/strong>. The Test License can be used for the purpose of testing, evaluation, training, or demonstration of Medical Devices. <strong><em>CDSCO or Central Drugs Standard Control Organisation<\/em><\/strong>, is the regulatory authority of India that issues the Test License for Import of Medical Devices in Form MD-17. To obtain a Test License for <a href=\"https:\/\/swaritadvisors.com\/medical-device-import-license\"><strong>Import of Medical Devices<\/strong><\/a>, the applicant need to apply to the regulatory authority through <strong><em>Form MD-16<\/em><\/strong> on an online website i.e., SUGAM. Scroll down to check more information regarding the grant of a Test License for Import under MDR, 2017.<\/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-6a3ab3b481640\" 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-6a3ab3b481640\"  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\/grant-of-test-license-for-import-under-mdr-2017\/#What_is_the_Primary_Purpose_of_Form_MD-16_and_Form_MD-17\" title=\"What is the\nPrimary Purpose of Form MD-16 and Form MD-17?\">What is the\nPrimary Purpose of Form MD-16 and Form MD-17?<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Eligibility_to_Get_Test_License_for_Import_under_MDR_2017\" title=\"Eligibility to\nGet Test License for Import under MDR, 2017\">Eligibility to\nGet Test License for Import under MDR, 2017<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Various_Conditions_for_Grant_of_Test_License_for_Import_of_Medical_Devices_in_India\" title=\"Various\nConditions for Grant of Test License for Import of Medical Devices in India\">Various\nConditions for Grant of Test License for Import of Medical Devices in India<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Essential_Documents_Required_to_Obtain_Test_License_for_Import_of_Medical_Devices\" title=\"Essential\nDocuments Required to Obtain Test License for Import of Medical Devices \">Essential\nDocuments Required to Obtain Test License for Import 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\/grant-of-test-license-for-import-under-mdr-2017\/#Step-by-Step_Process_to_Apply_for_Test_License_for_Import_of_Medical_Devices\" title=\"Step-by-Step\nProcess to Apply for Test License for Import of Medical Devices\">Step-by-Step\nProcess to Apply for Test License for Import of Medical Devices<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_Primary_Purpose_of_Form_MD-16_and_Form_MD-17\"><\/span>What is the\nPrimary Purpose of Form MD-16 and Form MD-17?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li><strong>Form\nMD-16<\/strong>: This is the application for a License to\nimport medical devices to evaluate, train, test, demonstrate, or conduct\nclinical trials.<\/li><li><strong>Form\nMD-17<\/strong>: Permission is granted by the Central Drugs\nStandard Control Organisationto import medical devices for\nevaluation, training, demonstration, or conduct clinical trials through this\nForm.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_to_Get_Test_License_for_Import_under_MDR_2017\"><\/span>Eligibility to\nGet Test License for Import under MDR, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Any importer who wants to import medical devices in India can apply for this License via Form MD-16 along with the vital documents and requisite fees. This License is used for the purpose of testing, training, clinical investigation, demonstration, etc., of Medical Devices. The Test License for Import is issued by the CLA or <strong>Central Licensing Authority<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Central-Licences-Approving-Authority\/\"><strong>[1]<\/strong><\/a><\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Various_Conditions_for_Grant_of_Test_License_for_Import_of_Medical_Devices_in_India\"><\/span>Various\nConditions for Grant of Test License for Import of Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nconditions for granting of Test License for the Import of Medical Devices are\nmentioned under <strong><em>Section 41 of the MDR, 2017<\/em><\/strong>. The conditions are as follows:<\/p>\n\n\n\n<ol><li>The CLA, if completely\nsatisfied with the fact that all the requirements for the application submitted\nin Form MD-16 comply with the Rules of the Act, shall issue a Test License in\nMD-17. The Central Licensing Authority conduct an investigation of the\napplication form and may hold an enquiry. In case the CLA is not satisfied, it\nmay cancel the application and is required to submit the cancellation reasons\nin writing within 30 days from the submission date of the application, as per\nRule 40 of the Sub-Rule (2).<\/li><li>The validity period of this\nLicense is 3 years from the date of issue of the Test License unless it is\ncancelled.<\/li><li>The CLA can issue a show cause\nnotice to any licensee or License holder if he or she is found to be breaching\nany rules, asking the License holder or Licensee for the reasons why his\/her\nLicense should not be cancelled.<\/li><li>The License holder is given an\nopportunity or a chance to explain in writing the reasons in their defence. If\nthe CLA will pass an order for the cancellation of the Test License or\notherwise &amp; record the reasons for passing the said order.<\/li><li>The Medical Device for which\nthe License has been issued is to be used for testing, training, demonstration,\nclinical investigation, etc. According to Sub-Rule (1) &amp; such purposes are\nsupposed to be carried out only at the premises or units which is specified in\nTest License. If in any instance, where the Medical Devices are taken to any\narea or place other than the one stated in the Test License, the CLA should be\ninformed in writing before taking action.<\/li><li>The Medical Devices at the time\nof import shall comprise the invoice, which includes the name &amp; quantity of\nthe medical device.<\/li><li>The medical devices and in-vitro\ndiagnostic medical devices, as mentioned in Sub-Rule (2), which aren&#8217;t being\nused, may be allowed to be destroyed or exported after importing the CLA.<\/li><li>A License holder whose License\nhas been revoked by the CLA, may file an appeal to the Central Government of\nIndia within 40 days from the date of order.<\/li><li>The owner of the Test License\nis required to maintain the record of all the main activities undertaken along\nwith the manufacturer name, import date &amp; the quantity imported.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Essential_Documents_Required_to_Obtain_Test_License_for_Import_of_Medical_Devices\"><\/span>Essential\nDocuments Required to Obtain Test License for Import of Medical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare some important documents required for obtaining a Test License for Import\nof Medical Devices in India:<\/p>\n\n\n\n<ol><li>Application Form;<\/li><li>Covering Letter;<\/li><li>Product label &amp; Brochure;<\/li><li>Testing protocol;<\/li><li>The description of the medical\ndevices or in-vitro diagnostic kit;<\/li><li>The description must include\nmaterials of construction, design label, intended use &amp; instructions for\nthe use of the Medical Devices;<\/li><li>FSC or Free Sale Certificate in\nthe Country of Origin;<\/li><li>Ethics Committee Approval (if\napplicable);<\/li><li>TR-6 Challan Justification or Utilisation.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step-by-Step_Process_to_Apply_for_Test_License_for_Import_of_Medical_Devices\"><\/span>Step-by-Step\nProcess to Apply for Test License for Import of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the process to apply for a Test License for Import of Medical Devices:<\/p>\n\n\n\n<ol><li>First, the applicant needs to register\non the SUGAM portal.<\/li><li>Then, the application for the\nLicense must be drafted in Form-16 along with the vital documents.<\/li><li>After that, the applicant needs\nto pay the fee along with submitting the required documents.<\/li><li>The application is to be\nsubmitted on the online portal.<\/li><li>After the approval by the\nconcerned authority, the Test License for Import will be issued in Form MD-17.<\/li><\/ol>\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>In 2020-21, there has been an exponential growth in the import of medical devices in India of 41% of around Rs. 63,000 crores. In India, the demand for medical devices is high and is regulated by the Central Government through CDSCO for better transparency &amp; service. \u00a0To get Import License for Medical Devices in India, the importers are required to comply with CDSCO&#8217;s Regulations. However, because of the complex system of getting a License, many manufacturers find the process extremely taking consuming &amp; confusing. The process complexity is the reason why it is necessity to take legal assistance and support for getting a Test License for Import of Medical Devices.<\/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\/what-is-the-meaning-of-form-md-8-and-form-md-10\/\">What is the Meaning of Form MD-8 and Form MD-10?\n<\/a><\/mark><\/p>\n\n","protected":false},"excerpt":{"rendered":"<p>As per Section 40 of the MDR, 2017, any type of medical device or in-vitro diagnostic medical device may be imported to run any type of training testing, clinical investigation, etc. An individual (importer or manufacturer) who wants to import the medical devices of Class A, B, C, or D to India can get a [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":12265,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[1067],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12242"}],"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\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=12242"}],"version-history":[{"count":22,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12242\/revisions"}],"predecessor-version":[{"id":12266,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12242\/revisions\/12266"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/12265"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=12242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=12242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=12242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}