{"id":48379,"date":"2022-09-08T11:42:44","date_gmt":"2022-09-08T06:12:44","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48379"},"modified":"2022-09-08T11:42:46","modified_gmt":"2022-09-08T06:12:46","slug":"application-procedure-for-class-c-and-d-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-c-and-d-medical-devices\/","title":{"rendered":"Application Procedure for Class C and D Medical Devices"},"content":{"rendered":"\n<p>Due to the large population, high demand and quick expansion of the medical device business, Indian medical device manufacturers are in favour of the establishment of medical device manufacturing units. 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> were introduced in order to meet the global standards of the medical device industry. There is a classification of medical devices on the basis of the risks involved. The devices are divided into Class A, B, C and D on the basis of the risk levels involved along with the device. The medical devices are required to be registered first in order to be imported, sold or manufactured in India. In order to obtain registration certificate of the medical device, it is mandatory to submit an application for the same. Application Procedure for Class C and D Medical Devices are regulated by the Central Licensing Authority, whereas Application Procedure for Class A and B Medical Devices are regulated by the State Licensing Authority of India. <\/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-c-and-d-medical-devices\/#Medical_Device_Rules_2017_%E2%80%93_An_Overview\" >Medical Device Rules 2017 \u2013 An\nOverview<\/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-c-and-d-medical-devices\/#Class_C_and_D_Medical_Devices_in_India\" >Class C and D 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-3\" href=\"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-c-and-d-medical-devices\/#Manufacturing_License_for_Class_C_and_D_Medical_Devices_in_India\" >Manufacturing License for Class\nC and D 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-4\" href=\"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-c-and-d-medical-devices\/#Loan_License_for_Class_C_and_D_Medical_Devices_in_India\" >Loan License for Class C and D\nMedical Devices in 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-c-and-d-medical-devices\/#Licensing_Procedure_for_Class_C_and_D_Medical_Devices_in_India\" >Licensing Procedure for Class C\nand D 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-c-and-d-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_%E2%80%93_An_Overview\"><\/span>Medical Device Rules 2017 \u2013 An\nOverview<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Medical Device Rules, 2017 were brought into effect on January 1st 2018, by the <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>. The Central Drug Standard Control Organization (CDSCO) divided medical devices in India into four different classes- Class A, B, C and D. Under this classification, medical devices are categorized based on the risks involved. The different classes of devices involve different licensing procedures and requirements. The categorization has been implemented to make sure that the patients get good quality service and treatments from Medical Devices, and the market should not have access to any unsafe, unregistered or uncertified medical devices. The Medical devices, on the basis of the risks involved, are categorized into four classes- <\/p>\n\n\n\n<ul><li><strong>Class A<\/strong>&#8211;\nDevices that have low risk, for example- thermometers and sphygmomanometers<\/li><li><strong>Class B<\/strong>&#8211;\nDevices that have low to medium risk, for example- needles and suction cannula<\/li><li><strong>Class C-<\/strong>\nDevices that have medium to high risk, for example- ventilator and joint\nimplants<\/li><li><strong>Class D<\/strong>&#8211;\nDevices that have high risk, for example- pacemakers and heart valves<\/li><\/ul>\n\n\n\n<p>The Indian\nGovernment has also released multiple notifications to include new medical\ndevices under different categories to keep up with innovation in the medical\ndevice sector. This has been done to ensure that new medical devices in the\nmarket do not go unchecked and uncovered from the ambit of MDR, 2017.<\/p>\n\n\n\n<p>In order to\nimport or manufacture Class C and D medical devices in India, the manufacturer\nmust obtain prior permission in the form of a manufacturing and Import license.\nThe Central Licensing Authority or CLA is responsible for providing permission\nfor the same and handling any other operations or functions relating to Class C\nand D medical devices. All the applications for the manufacturing license or\nloan license for Class C and D medical devices are submitted to the CLA under\nCDSCO. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Class_C_and_D_Medical_Devices_in_India\"><\/span>Class C and D Medical Devices\nin India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>With different\nlevels of risk involved, it is important to group different medical devices\naccording to their correct classification. The Central licensing authority\n(CLA) has made certain rules relating to the procedure to obtain CDSCO medical\ndevice registration for Class C and D Medical devices. Therefore, to\nsuccessfully the permission to manufacture or a loan license for the manufacture\nor sale of Class C and D Medical devices, it must be ensured that the\napplication is filed as per the right Form and procedure. The following table\nprovides a framework of the entire licensing process for Class C and D Medical\ndevices in India.<\/p>\n\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Application\n  Form<\/strong>\n  <\/td><td>\n  <strong>Approval\n  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-7: Application of Manufacturing \n  License \n  <\/td><td>\n  MD-9: Grant of manufacturing License\n  <\/td><td>\n  Class C and Class D Medical Devices\n  <\/td><td>\n  CDSCO\n  <\/td><\/tr><tr><td>\n  MD-8: Application of loan license\n  <\/td><td>\n  MD-10: Grant of loan licens<strong>e<\/strong>\n  <\/td><td>\n  Class C and Class D Medical Devices\n  <\/td><td>\n  CDSCO\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Manufacturing_License_for_Class_C_and_D_Medical_Devices_in_India\"><\/span>Manufacturing License for Class\nC and D Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to\napply for a manufacturing license and to obtain a license for manufacturing\nClass C and Class D medical devices, Form MD-7 and MD-9 are required. The medical\ndevice manufacturing license is granted by the Central Licensing Authority of\nIndia or CDSCO. Form MD-7 is an application form submitted to the CLA in order\nto obtain a license to sell, manufacture or trade Class C and D medical Devices\nin India. MD-9 is issued by the CLA as a license or approval to manufacture,\nsell, or distribute a Class C and D Medical Device. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Loan_License_for_Class_C_and_D_Medical_Devices_in_India\"><\/span>Loan License for Class C and D\nMedical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to\napply for a loan license for manufacturing Class C and Class D medical devices,\nForm MD-8 and MD-10 are required. The loan license for Class C and D devices is\nalso granted by the Central Licensing Authority of India or CDSCO. Form MD-8 is\nsubmitted to the CLA in order to obtain a loan license to sell, manufacture or\ntrade Class C and D medical Devices in India. MD-10 is a form which is granted\nby the CLA as approval of a loan license to manufacture, sell, or distribute a\nClass C and D Medical Device.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Licensing_Procedure_for_Class_C_and_D_Medical_Devices_in_India\"><\/span>Licensing Procedure for Class C\nand D Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to\nobtain the license for manufacturing and a Loan license for Class C and D\nMedical Devices in India, the following procedure is involved-<\/p>\n\n\n\n<ul><li>The applicant must register themselves with the\nMinistry of Health and Family welfare. <\/li><li>After registration, the applicant must submit Form\nMD-7 on the portal along with their business details and supporting documents.<\/li><li>If the applicant is applying for a loan license,\nhe must upload Form MD-8 with all the relevant documents and details. The form\nand fees are laid down in the Second Schedule of Part II of the Rules. The\nCentral Licensing Authority or CDSCO then checks and verifies all the relevant\ndetails and documents filed by the applicant. The CDSCO grants license only for\nClass C and D medical Devices. Class A and B medical devices are governed by\nthe State Licensing Authority.<\/li><li>After all the relevant documents are verified, the\nCDSCO grants a manufacturing license or a loan license to the applicant through\nthe form MD-9 and MD-10, respectively. <\/li><li>If, in case, the license is rejected, the\nCentral Licensing Authority or CDSCO notifies the reason for such rejection to the\napplicant within 45 days in writing.<\/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 Indian medical device market is growing at an increasing rate. India is marked as the 4<sup>th<\/sup> largest medical device market in the world. The medical device Industry is expected to increase its revenue by 13.01%, by the year 2027, with an approximate market volume of \u20b9 860.30 billion. Because of a wide range of rules and regulations governing a single registration process, the process can become extra lengthy. Although the Government is still working hard to simplify the complicated paperwork and regulations, but the entire landscape is still very complicated. A single mistake in one step can lead to huge financial losses and even the cancellation of a license. Therefore, it is always advisable to get professional help while getting any sort of medical license.<\/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\/application-procedure-for-class-a-and-b-medical-devices\/\">Application Procedure for Class A and B Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Due to the large population, high demand and quick expansion of the medical device business, Indian medical device manufacturers are in favour of the establishment of medical device manufacturing units. The medical device rules 2017[1] were introduced in order to meet the global standards of the medical device industry. There is a classification of medical [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48380,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2702],"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":4384,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48379"}],"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=48379"}],"version-history":[{"count":16,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48379\/revisions"}],"predecessor-version":[{"id":48396,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48379\/revisions\/48396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48380"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48379"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48379"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48379"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}