{"id":48360,"date":"2022-09-08T11:13:30","date_gmt":"2022-09-08T05:43:30","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48360"},"modified":"2022-09-08T11:13:32","modified_gmt":"2022-09-08T05:43:32","slug":"process-of-application-for-clinical-investigation-under-mdr-2017","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/process-of-application-for-clinical-investigation-under-mdr-2017\/","title":{"rendered":"Process of Application for Clinical Investigation under MDR, 2017"},"content":{"rendered":"\n<p>Central Drug Standard Control Organization or <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> is responsible for regulating and conducting clinical Investigations on Drugs in India. Chapter VII of the Medical device rules describes the clinical investigation of medical devices and clinical performance tests of new in vitro Diagnostic medical devices. The manufacturer or importer is required Application for Clinical Investigation of drugs before marketing them. The purpose of conducting a clinical investigation is to ensure the safety and efficacy of the medical device manufactured or sold in India. The Application for Clinical Investigation is submitted to the <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<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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Overview_of_Application_for_Clinical_Investigation\" >Overview of Application for\nClinical Investigation<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Application_for_Clinical_Investigation_%E2%80%93_Process\" >Application for Clinical\nInvestigation &#8211; Process<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Conditions_for_Obtaining_Permission_for_Clinical_Investigation\" >Conditions for Obtaining\nPermission for Clinical Investigation<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Rejection_of_Application_for_Clinical_Investigation\" >Rejection of Application for\nClinical Investigation<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Suspension_or_Cancellation_of_Permission_for_Clinical_Investigation\" >Suspension or Cancellation of\nPermission for Clinical Investigation<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Other_Conditions_for_Clinical_Investigation\" >Other Conditions for Clinical\nInvestigation<\/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\/process-of-application-for-clinical-investigation-under-mdr-2017\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Application_for_Clinical_Investigation\"><\/span>Overview of Application for\nClinical Investigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Indian\nhealthcare industry is growing rapidly &amp; is expected to reach $280 billion\nby the year 2025. The medical device market in India is among the top 20\nmedical device markets in the world and holds its current value at $5.2\nbillion. The purpose of Clinical investigation\nof medical products is to obtain data to evaluate the safety and quality\nstandards of medical products for the purpose they are used for. It is\nperformed to check any possibility of side effects or risks involved with the\ndevice. Just like the approval of drugs, the clinical investigation of the\ninvestigational medical device is important to be used in or on humans in order\nto check and investigate the performance, standard and safety of a medical\ndevice.<\/p>\n\n\n\n<p>Application for\nClinical Investigation of medical devices is submitted to the Central Licensing\nAuthority (CLA) through form MD-22 along with the documents specified in the\nseventh schedule.<\/p>\n\n\n\n<p><strong>The investigations are of two types- <\/strong><\/p>\n\n\n\n<ul><li><strong>Pilot Clinical Investigation<\/strong>: Pilot clinical Investigation is the kind of investigation carried out for the first time in human beings. It is performed in a small group of patients whose conditions or diseases are being studied to get specific information about the device before initiating the clinical study. A pilot clinical investigation is a study that provides information about the performance and safety of a device. Following are the objectives of a Pilot Clinical Investigation-<\/li><\/ul>\n\n\n\n<ol><li>Assessment of workability<\/li><li>Assessment of device mechanism<\/li><li>Finding a suitable method for the outcome<\/li><li>Finding an appropriate method of surrogate outcome<\/li><li>Assessment of eligibility criteria <\/li><li>Evaluation of logistics of pivotal investigation <\/li><li>To conduct Pilot Clinical Investigation on a Medical Device, there has to be a payment of the fees required, specified in the Second Schedule, along with the relevant information specified in the seventh schedule.<\/li><\/ol>\n\n\n\n<ul><li><strong>Pivotal Clinical Investigation<\/strong>: Pivotal Clinical Investigation is a final study that provides information about the safety and standards of the medical device. It is conducted in a larger population having diseases or conditions that are being studied. The Pilot Clinical Investigation data comprises information gathered by the Pilot Clinical Investigation, along with the required fees, which are mentioned in the Second schedule. The Pivotal studies are done to check the safety and quality standards of the devices. <\/li><\/ul>\n\n\n\n<p>Any clinical\ninvestigation of a medical device cannot be conducted without the permission of\nCDSCO. Class-A medical devices don&#8217;t need to provide data apart from a few\nexceptions listed by CDSCO. There are certain cases where CDSCO considers the\nClass A medical device data for the investigation to be necessary. In contrast,\nClass B, Class C and Class D medical devices are considered necessary for\nclinical investigation. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_for_Clinical_Investigation_%E2%80%93_Process\"><\/span>Application for Clinical\nInvestigation &#8211; Process<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>&nbsp;To obtain permission for clinical\ninvestigation, the applicant must apply to the Central Licensing Authority\n(CLA) through form MD-22. The application for clinical investigation is\nsubmitted along with the required fees and relevant information.<\/p>\n\n\n\n<p>After the\napplication form MD-22 is duly submitted along with the required fees and\nrelevant documents and information, if the Central Licensing Authority is\nsatisfied with all the relevant documents, it will grant permission to conduct\na clinical investigation of medical devices. The permission is granted in Form\nMD-23. Once permission is granted, the investigation process can be started as\nper the investigation plan that the Ethics Committee has approved. However, the\nclinical investigation must be registered with the Indian Clinical Trial\nregistry before making an application. Clinical investigation is started by\nenrolling the applicant within one year after the grant of permission. If not,\nthen it is important to obtain permission from the CLA.<\/p>\n\n\n\n<p><strong><em>However,\nthere are certain conditions on which the permission to conduct a clinical\ninvestigation on licensed medical devices. The conditions are as follows-<\/em><\/strong><\/p>\n\n\n\n<ul><li>When the ethics committee approves the study\/\ntrial<\/li><li>When the data generated during the study is not\nto be used by the&nbsp; Central Licensing\nAuthority to market, manufacture or import any investigational medical device\nin India<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_for_Obtaining_Permission_for_Clinical_Investigation\"><\/span>Conditions for Obtaining\nPermission for Clinical Investigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Once the\napplication for Clinical Investigation is submitted and permission is obtained,\nthe applicant is required to comply with the following conditions to conduct\nclinical investigations in India-<\/p>\n\n\n\n<ul><li>The Clinical Investigation should be started\nafter the registered Ethics Committee approves the clinical investigation plan.<\/li><li>The clinical investigation should be done\naccording to the approved clinical investigation plan, the Good Clinical\nPractices Guidelines, issued by CDSCO and per the Seventh Schedule provisions.<\/li><li>Before the first participant is registered in a\nclinical investigation, the clinical investigation must be registered with the\nClinical Trial Registry of India.<\/li><li>The sponsor must submit a yearly status report\nto the Central Licensing Authority detailing each clinical investigation&#8217;s\nstatus, including whether it is ongoing, completed, or terminated. If a\nclinical investigation is terminated, the Central Licensing Authority must be\ninformed in detail of the reasons for the termination within 30 days.<\/li><li>After careful analysis, the sponsor must provide\nthe Central Licensing Authority with information about any suspected unexpected\nserious adverse event reported during the clinical investigation on the subject\nwithin fourteen days of learning of its occurrence as specified in the Seventh\nSchedule and accordance with the procedure specified in these rules.<\/li><li>The applicant must offer complete medical\nmanagement or compensation under these rules if a subject of a clinical\ninvestigation is injured or dies during that clinical investigation.<\/li><li>Officers\nof the Central Licensing Authority, who may be accompanied by officers of the\nState Licensing Authority or outside experts, may inspect the sponsor&#8217;s\nfacilities, including their employees, subsidiaries, and branches, their\nagents, contractors, and subcontractors, as well as clinical investigation\nsites, to ensure compliance with the requirements of these rules for conducting\nclinical investigations.<\/li><li>Within a year of receiving permission, the\nclinical investigation must begin by enrolling the first participant;\notherwise, prior approval from the Central Licensing Authority will be needed\nto start the clinical investigation.<\/li><\/ul>\n\n\n\n<p>The Central Licensing\nAuthority may impose or exempt any conditions on the objective, design, subject\npopulation, subject eligibility, assessment, conduct, and treatment of clinical\ninvestigations when granting permission for a particular clinical\ninvestigation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Rejection_of_Application_for_Clinical_Investigation\"><\/span>Rejection of Application for\nClinical Investigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Suppose the\nCentral Licensing Authority (CLA) is not satisfied with the requirements to\ngrant permission to conduct clinical investigations in India. In that case, it\nmay reject the application for clinical investigation. The CLA must provide the\napplicant with reasons for rejecting the applications in writing within ninety\ndays from the date of application.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Suspension_or_Cancellation_of_Permission_for_Clinical_Investigation\"><\/span>Suspension or Cancellation of\nPermission for Clinical Investigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If a person who\nhas been granted permission to conduct clinical trials has failed to comply\nwith the required conditions of permission for clinical investigation or with\nany other provisions of the medical device rules, then the CLA may do the\nfollowing-<\/p>\n\n\n\n<ul><li>Issue a letter of warning outlining the deficiencies\ndiscovered<\/li><li>Prohibit the investigator or sponsor, as well as\ntheir employees, subsidiaries, branches, agents, contractors, and\nsubcontractors, from conducting any clinical investigation for the period it\ndeems appropriate<\/li><li>Suspend the permission for the period it deems\nappropriate or revoke the permission entirely or in part.<\/li><\/ul>\n\n\n\n<p>A person whose\npermit has been suspended, cancelled, etc., can file an appeal within thirty\ndays of receiving such an order by the government. The person is then given a\nchance to be heard in an enquiry. The appeal can be disposed of within sixty\ndays.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Other_Conditions_for_Clinical_Investigation\"><\/span>Other Conditions for Clinical\nInvestigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To inspect the\nfacilities, search for and seize data, documents, books, and medical\ndevices-including investigational medical devices and new in vitro diagnostic\nmedical devices-the Medical Devices Officer may enter any location related to\nthe clinical investigation or clinical performance evaluation with or without\nan expert present, with prior approval from the Central Licensing Authority,\nwith or without prior notice.<\/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>Clinical Investigations are based on a clinical investigation plan and Clinical performance evaluation is based on a Clinical performance evaluation plan. Both of these include detailed protocols of performance and conduct. During the process, it is important to protect the rights, safety and dignity of the subject, along with the ethical principles laid down for the same. Application for Clinical Investigation is a detailed process and a minor error in the application process may cause the rejection of the application. It is suggested to take help from professionals before filing the application to avoid extra costs caused by any kind of error. <\/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>Central Drug Standard Control Organization or CDSCO is responsible for regulating and conducting clinical Investigations on Drugs in India. Chapter VII of the Medical device rules describes the clinical investigation of medical devices and clinical performance tests of new in vitro Diagnostic medical devices. The manufacturer or importer is required Application for Clinical Investigation of [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48361,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2701],"acf":{"service_id":"508"},"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":2851,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48360"}],"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=48360"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48360\/revisions"}],"predecessor-version":[{"id":48378,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48360\/revisions\/48378"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48361"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48360"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48360"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}