{"id":47274,"date":"2022-08-24T15:10:51","date_gmt":"2022-08-24T09:40:51","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47274"},"modified":"2022-08-24T15:10:53","modified_gmt":"2022-08-24T09:40:53","slug":"medical-device-loan-license-conditions-documents-and-procedure","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/medical-device-loan-license-conditions-documents-and-procedure\/","title":{"rendered":"Medical Device Loan License: Conditions, Documents and Procedure"},"content":{"rendered":"\n<p>The Medical\nDevices and Rules, 2017 maintains the guidelines to provide a framework of the\nrules and regulations of Drugs, Medical Devices, Medical related products, IVDs\netc. To manufacture the medical devices, the manufacturer also needs to acquire\na manufacturing license from the licensing authorities. The same is the case\nwith acquiring a loan license for medical devices. A Medical Device Loan License\nis provided by the relevant licensing authority. For the Medical devices of\nClass A and B, the loan license is granted by the State Licensing Authority,\nwhereas the Central Licensing Authority is responsible for granting the Loan\nLicense to Class C and D medical devices, as per their risk levels. <\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Forms_required_for_loan_license_for_medical_devices\" >Forms\nrequired for loan license for medical devices<\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Approval_for_Medical_Device_Loan_License\" >Approval for Medical Device\nLoan License<\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Conditions_for_obtaining_Medical_Device_Loan_License_in_India\" >Conditions for obtaining Medical\nDevice Loan License 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:\/\/corpbiz.io\/learning\/medical-device-loan-license-conditions-documents-and-procedure\/#Documents_required_for_the_Medical_Device_Loan_License\" >Documents required for the\nMedical Device Loan License-<\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Application_for_Medical_Device_Loan_License\" >Application\nfor Medical Device Loan License<\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Procedure_for_obtaining_Medical_Device_Loan_License\" >Procedure for obtaining Medical\nDevice Loan 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\/medical-device-loan-license-conditions-documents-and-procedure\/#Validity_of_Medical_Device_Loan_License\" >Validity of Medical Device Loan\nLicense<\/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\/medical-device-loan-license-conditions-documents-and-procedure\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_required_for_loan_license_for_medical_devices\"><\/span>Forms\nrequired for loan license for medical devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To acquire a\nmedical device loan license, there are two steps involved-<\/p>\n\n\n\n<ul><li>Application of obtaining a loan license for the\npurpose of manufacturing or selling medical devices of Class A, B, C and D.<\/li><li>Obtaining the loan license for the purpose of\nmanufacturing or selling medical devices of Class A, B, C and D after approval\nof the relevant licensing authorities. <\/li><\/ul>\n\n\n\n<p>According to the\nmedical device rules 2017, The Medical Device Loan License has to be obtained\naccording to the Classes of Medical Devices based on the risks involved. <\/p>\n\n\n\n<p>The risk\ninvolved in Class A and B medical devices is Low and Low-medium, respectively,\nwhereas the risk involved in Class C and D medical devices are Medium-High and\nHigh, respectively. To obtain a medical device loan license, there are two\nlicensing authorities that provide approval to the devices according to their\nrisk categories; these authorities are-<\/p>\n\n\n\n<ol><li>State Licensing Authority.<\/li><li>CentralLlicensing Authority. <\/li><\/ol>\n\n\n\n<p>The State\nlicensing authority is responsible for the approval of loan license for the\nmanufacture or sale of Class A and B medical devices, whereas the Central\nlicensing authority or the CDSCO is responsible for the approval of loan license\nfor the manufacture or sale of Class C and D medical devices. There is a\nspecification of forms required for the application for a loan license and a\nForm provided by the licensing authority as the grant of a Loan License,\naccording to the different categories of the devices mentioned below- <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Application Form<\/strong>\n  <\/td><td>\n  <strong>Approval Form<\/strong>\n  <\/td><td>\n  <strong>Class RISK<\/strong>\n  <\/td><td>\n  <strong>Licensing&nbsp;&nbsp; Authority<\/strong>\n  <\/td><\/tr><tr><td>\n  MD-4 \n  Application of loan\n  license\n  <\/td><td>\n  MD-6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Grant of loan\n  license\n  <\/td><td>\n  Class A and\n  class B medical devices\n  <\/td><td>\n  State\n  licensing authority or SLA \n  <\/td><\/tr><tr><td>\n  MD-8\n  Application of loan license<strong><\/strong>\n  <\/td><td>\n  MD-10&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Grant of loan license<strong><\/strong>\n  <strong>&nbsp;<\/strong>\n  <\/td><td>\n  Class C and Class D Medical Devices<strong><\/strong>\n  <\/td><td>\n  Central Licensing Authority or CDSCO<strong><\/strong>\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Approval_for_Medical_Device_Loan_License\"><\/span>Approval for Medical Device\nLoan License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The State\nLicensing Authority (SLA) or the Central Licensing Authority (CLA)\/ CDSCO is\nresponsible for the approval of the medical devices loan license in India. For\nmedical devices of Class A and B, the State Licensing Authority is responsible,\nwhereas, for Class C and D, The Central Licensing Authority or CDSCO is\nresponsible. For medical device loan licenses or Class A and B medical devices,\nThe SLA, after accepting the applications in form MD-4, provides a grant or\napproval of Loan License in form MD-6. Whereas, after obtaining applications\nfor Class C and D medical devices in form MD-8, the SLA provides permission for\nLoan License in form MD-10.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_for_obtaining_Medical_Device_Loan_License_in_India\"><\/span>Conditions for obtaining Medical\nDevice Loan License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the <strong>Medical Devices 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>, the State Licensing Authority and Central Licensing Authority provide approval for the medical device loan license for Class A and B through form MD-6 and for Class C and D through form MD-10. After receiving a grant for loan license, the following conditions are required to be followed by the license holder-<\/p>\n\n\n\n<ul><li>The license holder is required to produce his\nlicense whenever requested by any medical device officer or any officer from\nSLA and CLA. <\/li><li>In case of any suspected or unforeseen serious\nincident, the license holder is required to inform the SLA or CLA about the\nincident and emergency actions taken for the same within 15 days of the\nincident. <\/li><li>Before making any major changes, the license\nholder must get approval for the same. The request should be made as per the\nSixth Schedule. After getting the approval, the license holder is required to\nsubmit the details of the changes to the SLA or CLA within 45 days. <\/li><li>According to rule 83, sub-rule (3), the license\nholder is required to perform tests in the laboratory before the products are released.\nAll the test documents are required to be submitted in CLA or SLA. <\/li><li>The audit should be documented inform MD-11<\/li><li>The test samples are required to be preserved\nfor 180 days post expiry. <\/li><li>The manufacturing and sales records should be\nkept safe by the license holder and are required to be produced to the medical\nofficer whenever requested. <\/li><li>If the manufacturing of the device has stopped\nfor more than 30 days, the manufacturer should inform the same to the CLA or\nSLA. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_the_Medical_Device_Loan_License\"><\/span>Documents required for the\nMedical Device Loan License-<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents\nrequired for the purpose of obtaining a Medical Device Loan License for Class A\nand B medical devices along with Form MD-4 are accompanied by the fee, which is\nspecified in the Second schedule. The documents which are required in obtaining\nLoan License are specified in Part II of the Fourth Schedule. <\/p>\n\n\n\n<p>The documents\nrequired for the purpose of obtaining a loan license for classes C and D, along\nwith the form MD-8, are accompanied by the fee, which is specified in the second\nschedule. The details of the required documents are specified in clause (ii) of\npart II of the fourth schedule.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_for_Medical_Device_Loan_License\"><\/span>Application\nfor Medical Device Loan License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to\nobtain Loan License for the medical devices, the manufacturer first needs to\nsubmit an application for approval of a loan license to manufacture or sell\nmedical devices. Different medical devices require different forms to be filled\nfor the same purpose. For class A and B medical devices, form MD-4 has to be\nfilled and submitted to the State Licensing Authority in order to proceed with\nthe further loan license proceedings. For class C and D medical devices, form\nMD-8 is required to be filled and submitted to the Central Licensing Authority\nor CDSCO to proceed further with the Loan license acquiring process. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_obtaining_Medical_Device_Loan_License\"><\/span>Procedure for obtaining Medical\nDevice Loan License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to obtain\nLoan License for Medical Device for Class A, B, C and D, the following\nprocedures are required to be followed-<\/p>\n\n\n\n<ul><li>The applicant is required to register himself with the Ministry of Health and Family welfare.<\/li><li>Form MD-4 is required to be filled by the manufacturer in order to apply for a loan license for Class A &amp; B medical devices. <\/li><li>Form MD-8 is required to be filled by the manufacturer in order to apply for a loan license for Class C and D medical devices. <\/li><li>All the vital documents must be uploaded according to sub-rule (1).<\/li><li>The applicant of both <a href=\"https:\/\/corpbiz.io\/learning\/form-md-8-and-form-md-10\/\"><strong>form MD-4 and MD-8<\/strong><\/a> must upload the important paperwork before submitting the undertaking as specified by the Quality Management System.<\/li><li>The submitted application of form MD-4 is investigated by the state licensing authority, and Form MD-8 is submitted by the Central Licensing Authority. <\/li><li>Once the application is checked by the concerned licensing authorities, the application is then approved in the form MD-6 for classes A and B and MD-10 for Class C and D loan licenses. <\/li><li>If in case the license is rejected, the CLA and SLA are required to notify the applicant within 45 days in writing. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_Medical_Device_Loan_License\"><\/span>Validity of Medical Device Loan\nLicense<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The loan license\nissued in the form MD-6 and MD-10 remain valid for the time period of five\nyears, where it is essential for the license holder is required to pay the license\nretention fee as specified in the second schedule before completion of the\nperiod of five years from the date of issue of license unless it gets\ncancelled. If in case the license gets cancelled, the applicant can file for an\nappeal under CLA or SLA within 45 days of cancellation. <\/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> A loan license is a license which is issued for the manufacturing of medical devices by the State Licensing Authority or the Central Licensing Authority. It is provided to a person who needs to use the manufacturing site of any other license holder for the purpose of manufacturing medical devices, where the real license holder also manufactures the same medical device as the loan licensee at that site. According to Rule 20 and Rule, 21 of Medical Devices Rules 2017, a manufacturer who has a manufacturing license but does not have sterilization facilities has to obtain a loan license in form MD-4 for class A and B medical devices and MD-8 for class C and D 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\/documents-needed-for-cdsco-loan-license\/\">Documents needed for CDSCO Loan License<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medical Devices and Rules, 2017 maintains the guidelines to provide a framework of the rules and regulations of Drugs, Medical Devices, Medical related products, IVDs etc. To manufacture the medical devices, the manufacturer also needs to acquire a manufacturing license from the licensing authorities. The same is the case with acquiring a loan license [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47275,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2633],"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":8041,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47274"}],"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=47274"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47274\/revisions"}],"predecessor-version":[{"id":47291,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47274\/revisions\/47291"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47275"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}