{"id":47412,"date":"2022-08-25T14:17:55","date_gmt":"2022-08-25T08:47:55","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47412"},"modified":"2022-08-25T14:17:56","modified_gmt":"2022-08-25T08:47:56","slug":"grant-of-test-license-for-manufacture-under-mdr-2017","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/grant-of-test-license-for-manufacture-under-mdr-2017\/","title":{"rendered":"Grant of Test License for Manufacture under MDR, 2017"},"content":{"rendered":"\n<p>According to the <strong>Medical Device Rules (MDR) 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>, a small quantity of Class A, B, C, and D medical devices can be manufactured to perform clinical investigation, test, examination, demonstration or training. For this reason, an application form is made in the form MD-12 and is required to be submitted to the Central Licensing Authority, along with the required fee, which is specified in the Second Schedule. The Central Licensing Authority will then inspect all the necessary documents and, on being satisfied, will grant a test license for manufacture in Form MD-13, as per Medical Devices Rules, 2017. <\/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-manufacture-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-manufacture-under-mdr-2017\/#Scope_of_Medical_Device_Industry_in_India\" >Scope of Medical Device Industry 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\/grant-of-test-license-for-manufacture-under-mdr-2017\/#Forms_Required_for_Test_License_for_Manufacture\" >Forms Required for Test License for Manufacture<\/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-manufacture-under-mdr-2017\/#Documents_required_for_Test_License_for_Manufacture\" >Documents required for Test License for\nManufacture<\/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-manufacture-under-mdr-2017\/#Procedure_to_Apply_for_Test_License_to_Manufacture\" >Procedure to Apply for Test License to Manufacture<\/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-manufacture-under-mdr-2017\/#Grant_of_Test_License_for_Manufacture\" >Grant of Test License for Manufacture<\/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-manufacture-under-mdr-2017\/#Validity_of_Test_License_for_Manufacture\" >Validity of Test License for Manufacture<\/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-manufacture-under-mdr-2017\/#Conditions_of_Test_License_for_Manufacture\" >Conditions of Test License for Manufacture<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/corpbiz.io\/learning\/grant-of-test-license-for-manufacture-under-mdr-2017\/#Cancelling_of_Test_License_for_Manufacture\" >Cancelling of Test License for Manufacture<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/corpbiz.io\/learning\/grant-of-test-license-for-manufacture-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 <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical device<\/strong><\/a> rules 2017, the application for a test license of import or manufacture shall be rejected if it is found to be misleading or fake, after giving a chance 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=\"Scope_of_Medical_Device_Industry_in_India\"><\/span>Scope of Medical Device Industry in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Revenue of the Medical Device\nMarket is anticipated to reach around \u20b9 466.80 billion in the year 2022,\naccording to the India Brand Equity Foundation. The largest segment in Medical\nDevice Market is covered by Other Medical Devices, with a market volume of\naround \u20b9 246 billion in the year 2022. There is an anticipation in the growth\nrate of revenue by 13.01%, by the year 2027, with an approximate market volume\nof \u20b9 860.30 billion. Although, in a global context, most payment is expected to\nbe produced by the United States, resulting in a figure of around \u20b9 13,020\nbillion in the year 2022. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_Required_for_Test_License_for_Manufacture\"><\/span>Forms Required for Test License for Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To obtain the test license to\nmanufacture, conduct a clinical investigation, test, examination, demonstration\nor training, the applicant must submit form MD-12 and the required documents to\nthe central licensing Authority. The Central Licensing Authority may grant a\ntest license to the applicant in form MD-13. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_Test_License_for_Manufacture\"><\/span>Documents required for Test License for\nManufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To obtain a Test license for\nmanufacture, as per Medical Device Rules 2017, there are a few documents which\nare to be attached along with the application made under sub-rule (1). The\npapers are as follows-<\/p>\n\n\n\n<ul><li>A short detail of the medical device along with\nits intended use, materials used for manufacturing the device, product design,\nand an undertaking stating all the requirements that have been provided to\nmanufacture that device. <\/li><li>The list of all the required instruments and\nequipment <\/li><li>List of qualified personnel involved in the\nprocess<\/li><li>A copy of the manufacturing license which is\nissued under the Medical Device Rules, 2017 (if any) <\/li><li>An approval letter which authorizes to conduct\nof research and development procedures, which is published by any government\norganization (if any) <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Apply_for_Test_License_to_Manufacture\"><\/span>Procedure to Apply for Test License to Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To apply for the test license to\nmanufacture, conduct a clinical investigation, test, examination, demonstration\nor training, the applicant is required to follow specific procedures-<\/p>\n\n\n\n<ul><li>The registration on the SUGAM portal is an\nessential requisite for the process of applying for a test license. The\napplicant is required to register on the SUGAM portal first.<\/li><li>The application must be drafted in Form MD-12\nalong with the essential documents.<\/li><li>The government feed is to be paid along with\nsubmitting the required documents. <\/li><li>The application is then required to be submitted\non the medical device portal.<\/li><li>After approval, the license will be provided in\nform MD-13.&nbsp; <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Grant_of_Test_License_for_Manufacture\"><\/span>Grant of Test License for Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CLA or Central Licensing\nAuthority, after checking all the rules and requirements are in compliance with\nthe Medical Device Rules 2017, will grant a test license for manufacture in\nForm MD-13. The CLA is also authorized to reject the applications which do not\ncomply with the requirements, where for such rejection, it is required to\nmention the reasons to the applicant in writing, within 30 days of submission\nof the application. The Licensee is required to have a record of the quantity\nof the product which is manufactured under the test license. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_Test_License_for_Manufacture\"><\/span>Validity of Test License for Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Under sub-rule (3) of the medical\ndevice rule 2017, the test license for manufacture is granted. The permit will\nremain valid for the period of three years from the date of issue unless it is\ncancelled by the authorities for some reason. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_of_Test_License_for_Manufacture\"><\/span>Conditions of Test License for Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Licensing Authority\nor CLA, under the Medical Device Rule 2017, grants a test license for\nmanufacture in Form MD-13, under rule 31. <\/p>\n\n\n\n<p>The test license is subject to\ncertain conditions, which are mentioned below-<\/p>\n\n\n\n<ul><li>The medical device for which the test license\nhas been granted shall only be used for clinical investigation, test,\nexamination, demonstration or training at a place mentioned in the license. <\/li><li>The Licensee has to allow any medical device\nofficer to enter any manufacturing premise with or without notice to make sure\nthat only clinical investigation, test, examination, demonstration or training\nis being conducted on the medical device. <\/li><li>The Licensee should maintain a record of the\nnumber of medical devices manufactured, tested and stored, along with their disposition.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cancelling_of_Test_License_for_Manufacture\"><\/span>Cancelling of Test License for Manufacture<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Central Licensing Authority may\nbe unsatisfied with the inspection of specific conditions and requirements to\ngrant the test license for manufacturing medical devices. The problem arises\nwhen any licensee under section 31 violates any of the Medical Device Rules\n2017; the Central Licensing Authority then issues a show cause notice to the\nLicensee, questioning why the license shall not be cancelled. Licensee should\nanswer in writing. After receiving the written answer submitted by the\nLicensee, the Central Licensing Authority may pass an order to cancel the\nlicense or otherwise and is required to record their reason for doing so. The\nLicensee whose license has been cancelled by the Central Licensing Authority\nmay file an appeal to the Central Government within forty-five days of the date\nof order. <\/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>The medical device Industry is\ncontinuing to grow steadily in India in recent years. The development in\nMedical Technology and Increased investment result from the demand for\ninnovative medical devices. Along with the advantages, the Industry is also\nfacing some challenges in some complex regulatory processes, reimbursement\nrestrictions, and the high cost of developing and advancing technology in the Medical\nIndustry. The complexity of the process is the reason why it\u2019s a necessity to\nget legal aid and support for obtaining a test license for manufacture of\nmedical 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-import-under-mdr-2017\/\">Grant of Test License for Import under MDR, 2017<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>According to the Medical Device Rules (MDR) 2017[1], a small quantity of Class A, B, C, and D medical devices can be manufactured to perform clinical investigation, test, examination, demonstration or training. For this reason, an application form is made in the form MD-12 and is required to be submitted to the Central Licensing Authority, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47413,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2639],"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":3510,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47412"}],"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=47412"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47412\/revisions"}],"predecessor-version":[{"id":47426,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47412\/revisions\/47426"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47413"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}