{"id":47243,"date":"2022-08-24T14:30:14","date_gmt":"2022-08-24T09:00:14","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47243"},"modified":"2022-08-24T14:30:16","modified_gmt":"2022-08-24T09:00:16","slug":"application-procedure-for-class-a-and-b-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-a-and-b-medical-devices\/","title":{"rendered":"Application Procedure for Class A and B Medical Devices"},"content":{"rendered":"\n<p>The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority or NRA of India, which works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare under the government of India. The DCGI is the head of <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>, responsible for issuing medical device rules and additional regulations. To improve India&#8217;s Drugs and Medical Device regulations, the Ministry of Health and Family Welfare notified 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>. As per the new rules, the medical devices have been classified as Class A, B, C and D devices on the basis of the risks involved with them. Class A and B Medical Devices have Low and Low-Moderate risk, respectively, whereas Class C and D Medical Devices have Moderate and Moderate-High risk, respectively. <\/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\/application-procedure-for-class-a-and-b-medical-devices\/#Medical_Device_Rules_2017\" >Medical Device Rules, 2017<\/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\/application-procedure-for-class-a-and-b-medical-devices\/#Categorization_of_the_Medical_Devices\" >Categorization of the Medical Devices<\/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\/application-procedure-for-class-a-and-b-medical-devices\/#Manufacturing_License_for_Class_A_and_B_Medical_devices_in_India\" >Manufacturing License for Class A and B Medical\ndevices 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\/application-procedure-for-class-a-and-b-medical-devices\/#Loan_License_for_Class_A_and_B_Medical_devices_in_India\" >Loan License for Class A and B Medical devices\nin India<\/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\/application-procedure-for-class-a-and-b-medical-devices\/#Application_Procedure_for_obtaining_CDSCO_License_for_Class_A_and_B_Medical_Devices_in_India\" >Application Procedure for obtaining CDSCO License\nfor Class A and B 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-6\" href=\"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-a-and-b-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Rules_2017\"><\/span>Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 31st January 2017, The Ministry of Health and Family Welfare notified the medical device rules, 2017.<a> <\/a>According to the rules, the manufacturing and Import license will remain valid unless it is revoked or cancelled. The entire process of applying for a license will be done online through the E portal. The SUGAM portal has made the CDSCO medical device registration process easier and more convenient. Applications for Class A and B Medical Devices can be submitted online on the SUGAM portal, where the approval will be granted by the SLA or State Licensing Authority; Applications for Class C and D Medical devices are approved by the CLA or Central licensing authority through SUGAM portal.<\/p>\n\n\n\n<p>To submit an application for the\nmanufacturing license for Class A and B Medical Devices, the application for\nthe manufacturing license is submitted to the State Licensing Authority of the\nstate where the manufacturing unit is located. The same procedure is followed\nfor submitting a loan license for Class A and B medical Devices, with certain\nadditional requirements. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Categorization_of_the_Medical_Devices\"><\/span>Categorization of the Medical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the Medical Device Rules 2017, medical devices have been divided into four different categories according to the risk classification of the devices. For the purpose of obtaining a manufacturing or loan license for Class A and B medical Devices, the applicant must choose the correct categorization of the devices according to their risk classification.\u00a0<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  Application\n  Form&nbsp;\n  <\/td><td>\n  Approval\n  Form&nbsp;\n  <\/td><td>\n  Class Risk&nbsp;\n  <\/td><td>\n  Licensing&nbsp;&nbsp;\n  Authority&nbsp;\n  <\/td><\/tr><tr><td>\n  MD-3-\n  Application of\n  manufacturing &nbsp;\n  License&nbsp;\n  <\/td><td>\n  MD-5- \n  Grant of manufacturing License&nbsp;\n  <\/td><td>\n  Class A and Class B Medical Devices&nbsp;\n  <\/td><td>\n  State Licensing Authority&nbsp;\n  <\/td><\/tr><tr><td>\n  MD-4&nbsp;\n  Application of\n  loan license&nbsp;\n  <\/td><td>\n  MD-6- \n  Grant of loan license&nbsp;\n  <\/td><td>\n  Class A and class B medical devices&nbsp;\n  <\/td><td>\n  State licensing authority&nbsp;\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>The licensing authorities have\nmade rules solely on the basis of the risks involved with the devices -. The\npermission for license or manufacturing of these devices is given only after analysing\nthe risks involved in different categories of the devices. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Manufacturing_License_for_Class_A_and_B_Medical_devices_in_India\"><\/span>Manufacturing License for Class A and B Medical\ndevices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>For the purpose of applying for\nand obtaining a license for manufacturing of Class A and Class B medical\ndevices, form MD-3 and MD-5 are used. The permission is granted by the State\nLicensing Authority of India. Form MD-3 is an application form for the purpose of\nobtaining a license to sell, manufacture or trade Class A and B medical Devices\nin India. The CDSCO certificate is granted as per the format under Form MD-5 by\nthe SLA as a permit or license to manufacture, sell, or distribute a Class A or\nClass B Medical Device. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Loan_License_for_Class_A_and_B_Medical_devices_in_India\"><\/span>Loan License for Class A and B Medical devices\nin India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To apply for a Loan license to\nmanufacture, sell or distribute Class A and B medical Devices in India, form\nMD-4 and MD-6 are used. The permission for the same is also granted by the\nState Licensing Authority of India. Form MD-4 is submitted as an application\nfor obtaining a loan license for the manufacturing, sale or distribution of\nClass A and B medical Devices in India, whereas Form MD-6 is a form given by\nthe SLA as approval of a loan license for the purpose of manufacture, sale or\ndistribution of Class A and B medical Devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_Procedure_for_obtaining_CDSCO_License_for_Class_A_and_B_Medical_Devices_in_India\"><\/span>Application Procedure for obtaining CDSCO License\nfor Class A and B Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to apply to obtain the\nlicense for manufacturing and loan license for Class A and B medical devices in\nIndia, the following steps are to be followed-<\/p>\n\n\n\n<ul><li>The first step is the registration of the\napplicant with the Ministry of Health and Family Welfare. <\/li><li>After registration, the applicant must upload Form\nMD-3 on the SUGAM portal along with the relevant details and required\ndocuments.<\/li><li>If the applicant is applying for a loan license,\nhe must upload Form MD-4 with all the required documents and details. The form\nand fees are submitted according to the Second Schedule of Part III. <\/li><li>After submitting the form and the required\ndocuments, the applicant must submit an undertaking as required by the Quality Management\nSystem. <\/li><li>The State Licensing Authority then checks and\nverifies all the relevant details and documents submitted by the applicant. The\nState Licensing Authority is responsible for approving licenses only for Class\nA and B medical Devices. Class C and D medical devices are governed by the\nCentral Licensing Authority. Therefore, any misclassification of medical device\nat the time of filing the license application may lead to immediate rejection\nby the SLA.<\/li><li>After all the relevant documents are verified,\nthe SLA grants a manufacturing license or a loan license to the applicant\nthrough the Form MD-5 and MD-6, respectively. <\/li><li>If in case, the license is rejected, the State\nLicensing Authority notifies the applicant within 45 days in writing,\nmentioning the reason for such rejection.<\/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>The medical device sector has developed rapidly over time and plays an important role in every part of healthcare sector. It plays a major role in getting an easy access to the healthcare services, due to which there has been a rapid increase in the import and manufacture of the medical devices in India. There is an anticipation in the growth rate of revenue in medical device Industry by 13.01%, by the year 2027, with an approximate market volume of \u20b9 860.30 billion. <\/p>\n\n\n\n<p>While there is a much larger scope for the medical device market, the manufacturers in contrast, are concerned about the complex differentiation of the medical devices as per their risk and class. Improper registration process can lead to losses in business or sales and can hamper supply. The regulations in medical device market are also subject to price limits. Moreover, once a medical device gets registered, there is a necessary requirement of a license in order to manufacture, sell or import the medical devices. One small mistake in the registration process can lead to a chain of huge losses. Because of the complexity of the process, it is always advisable to get professional help and guidance in such complex tasks, because one minute mistake can lead to cancellation of license, which may cause delay in the entire process and hamper millions of lives.  <\/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\/different-classes-of-medical-device-their-risk-levels\/\">Different Classes of Medical Device &amp; their Risk Levels \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority or NRA of India, which works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare under the government of India. The DCGI is the head of CDSCO, responsible for issuing medical device rules and additional regulations. To [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47244,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2631],"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":5258,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47243"}],"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=47243"}],"version-history":[{"count":11,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47243\/revisions"}],"predecessor-version":[{"id":47257,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47243\/revisions\/47257"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47244"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47243"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47243"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47243"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}