{"id":47396,"date":"2022-08-25T14:04:18","date_gmt":"2022-08-25T08:34:18","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47396"},"modified":"2022-10-27T12:29:09","modified_gmt":"2022-10-27T06:59:09","slug":"grant-of-test-license-for-import-under-mdr-2017","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/grant-of-test-license-for-import-under-mdr-2017\/","title":{"rendered":"Grant of Test License for Import under MDR, 2017"},"content":{"rendered":"\n<p>According to section 40 of 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>, any kind of medical device or in-vitro diagnostic medical device may be imported in order to run any kind of clinical investigation, test, training, etc. Any person who is willing to import medical device is required to apply for a test license for the same. The application is submitted to the Central Licensing Authority or CLA in Form MD-16, along with the required fees which is specified in the Second Schedule. After receiving the application, the Central Licensing Authority is required to decide the quantity of the Medical Devices, after considering the facts like requirement for the test, approved clinical investigation plan, and the documents which are submitted by the applicant. Scroll down to check more information regarding Test License for Import.<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Types_of_test_licenses\" >Types of test licenses<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Medical_Device_Officer_and_Device_testing_laboratory\" >Medical Device Officer and Device testing laboratory<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Forms_required_for_test_license_for_Import\" >Forms required for test license for Import<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Conditions_for_grant_of_test_licence_of_Medical_Devices_for_Import\" >Conditions for grant of test licence of Medical Devices 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\/grant-of-test-license-for-import-under-mdr-2017\/#Eligibility_for_obtaining_Test_License_for_Import\" >Eligibility for obtaining Test License for Import<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Documents_required_to_obtain_Test_License_for_Import\" >Documents required to obtain Test License for Import<\/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\/grant-of-test-license-for-import-under-mdr-2017\/#Procedure_to_apply_for_test_license_for_Import_of_Medical_Device\" >Procedure to apply for test license for Import of Medical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/grant-of-test-license-for-import-under-mdr-2017\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_test_licenses\"><\/span>Types of test licenses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the Medical device\nrules, there are two types of test licenses available for Medical Devices- <\/p>\n\n\n\n<ol><li>Test\nlicence to manufacture for a test, evaluation, clinical investigations, etc.,\nas mentioned in section 31 of the Medical Device Rules, 2017. <\/li><li>Test\nlicence for import for a test, evaluation, clinical investigations, etc., as\nmentioned in section 40 of the Medical Device Rules, 2017. <\/li><\/ol>\n\n\n\n<p>As per section 92 of the Medical\ndevice rules 2017, the application for a test license of import or manufacture\nshall be rejected if it is found to be misleading or fake, after giving a\nchance to the applicant to clarify his reasons and be unsatisfied. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Officer_and_Device_testing_laboratory\"><\/span>Medical Device Officer and Device testing laboratory<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per section 18 of the Medical\nDevice Act 2017, The Central Government may designate a government analyst as a\nmedical device testing officer or a medical device officer. The medical device\ntesting officer may be a Government Analyst, who is appointed under sec 20 of\nthe act, while the medical device officer may be an inspector, who is appointed\nas per section 21 of the act. As per section 19 of the Act, the Central\nGovernment may establish Central medical devices testing laboratory in order to\nconduct test and evaluation of medical devices or to make an appellate laboratory\nor for any other function.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_required_for_test_license_for_Import\"><\/span>Forms required for test license for Import<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To obtain the test license to import\nfor test, evaluation, clinical investigations, etc. the applicant must submit\nform MD-16 and the required documents to the central licensing Authority. The\nCentral Licensing Authority may grant a test license to the applicant in form\nMD-17. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_for_grant_of_test_licence_of_Medical_Devices_for_Import\"><\/span>Conditions for grant of test licence of Medical Devices for Import <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 41 of the Medical Device\nRules, 2017 defines conditions for the grant of test licence for import for\ntest, evaluation, clinical investigations, etc. The conditions are as follows- <\/p>\n\n\n\n<ul><li>The Central Licensing Authority, if satisfied\nwith the fact that all the requirements for the application submitted in Form\nMD-16 complies with the rules of the act, shall grant a test license in Form\nMD-17. The CLA may also hold an enquiry during the investigation process of the\napplication form. If the CLA is not satisfied, it may reject the applications\nand is required to submit the reasons for rejection in writing within thirty\ndays from the date of submission of the application\u00b8 as per rule 40 of the\nsub-rule (2). <\/li><li>The Medical Device for which the test licence\nhas been granted, is to be used only for the purpose of clinical investigation,\ntest, training, etc. as per sub rule (1), and such clinical investigation,\ntest, training, etc. is supposed to be carried only at the premises which is\nspecified in the test license. If in any case, where the Medical device is\ntaken to any place other than the one specified in the test license, the\nCentral Licensing Authority should be informed in writing before taking the\naction. <\/li><li>The test license holder is required to maintain\nthe record of all the activities undertaken, along with the manufacturer name,\ndate of import and the quantity imported. <\/li><li>The Medical Device during the import shall\ninclude the invoice which includes the name and quantity of the medical device.\n<\/li><li>The validity period of the test license will be\nfor a time period of three years from the date of Issue unless it is cancelled.\n<\/li><li>The medical devices along with in-vitro\ndiagnostic medical device as mentioned in sub-rule (2), which are not being\nused, may be allowed to be exported or destroyed under after informing the\nCentral Licensing Authority. <\/li><li>The Central Licensing Authority can issue a show\ncause notice to any licensee, if he is found out to be violating any provisions\nof the rules, asking the licensee for the reasons why his license should not be\ncancelled. <\/li><li>The licensee is given an opportunity to explain\nin writing the reasons in his defence. If the Central Licensing Authority will\nthen pass an order for cancellation of the license or otherwise, and record the\nreasons for passing the said order.<\/li><li>A licensee whose license has been cancelled by\nthe Central Licensing Authority, may file an appeal to the Central Government within\nforty five days from the date of order.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_for_obtaining_Test_License_for_Import\"><\/span>Eligibility for obtaining Test License for Import<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Any importer or a manufacturer,\nwho wants to import a small quantity of Class A, B, C or D medical devices to\nIndia is can apply for the test license by Form MD-16 along with necessary\ndocuments and required fee. The test license is used for the purpose of\nclinical investigation, test, training, etc. of medical devices. The Central\nLicensing Authority is responsible to grant test license for medical devices by\nform MD-17. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_obtain_Test_License_for_Import\"><\/span>Documents required to obtain Test License for Import<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Application Form<\/li><li>TR-6 challan justification\/ utilization<\/li><li>Covering letter <\/li><li>Testing protocol<\/li><li>Product label and Brochure <\/li><li>Free sale certificate or FSC in the country of origin <\/li><li>Ethics committee approval (If applicable)<\/li><li>Notarised Agreement- If in case when a firm has applied for the CDSCO test license, and has used the testing facility of another firm, then the firm should also submit a copy of Notarized Agreement between two firms, completely authenticated by the applicant. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_apply_for_test_license_for_Import_of_Medical_Device\"><\/span>Procedure to apply for test license for Import of Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to apply for the test license for Import of Medical\nDevice, the applicant must follow these steps:<\/p>\n\n\n\n<ul><li>The registration on the SUGAM portal is an essential requisite for the process of applying for a test license. The applicant is required to register on the SUGAM portal first.<\/li><li>The application must be drafted in Form MD-16 along with the essential documents.<\/li><li>The government fees is to be paid along with submitting required documents. <\/li><li>The application is then required to be submitted on the medical device portal.<\/li><li>After approval, the test license for Import will be provided in form MD-17.<\/li><li>The Validity of the document remains till one year from the date of issue. <\/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>There has been a rise in the import of medical devices of 41%, of about Rs 63,000 crores in the year 2020-21. Medical devices are in high demand in India and are regulated by the government, through <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>, for a better service and transparency. The Importers are required to comply with the regulations of CDSCO in order to obtain permission or license to import or manufacture the medical devices in India. However, due to a long and complex system of obtaining a license, many manufacturers find the entire process extremely confusing and time taking. There are major challenges in some complex regulatory processes, reimbursement restrictions, and the high cost in developing and advancing technology in the Medical Industry. The complexity of the process is the reason why it\u2019s a necessity to get legal aid and support for obtaining 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:\/\/corpbiz.io\/learning\/grant-of-test-license-for-manufacture-under-mdr-2017\/\">Grant of Test License for Manufacture under MDR, 2017<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>According to section 40 of the Medical Device Rules 2017[1], any kind of medical device or in-vitro diagnostic medical device may be imported in order to run any kind of clinical investigation, test, training, etc. Any person who is willing to import medical device is required to apply for a test license for the same. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47397,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2638],"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":3203,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47396"}],"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=47396"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47396\/revisions"}],"predecessor-version":[{"id":50352,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47396\/revisions\/50352"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47397"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47396"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47396"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47396"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}