{"id":46609,"date":"2022-08-12T13:02:04","date_gmt":"2022-08-12T07:32:04","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46609"},"modified":"2022-08-25T11:14:13","modified_gmt":"2022-08-25T05:44:13","slug":"what-is-form-md-7-and-form-md-9","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-is-form-md-7-and-form-md-9\/","title":{"rendered":"What is FORM MD-7 and FORM MD-9?"},"content":{"rendered":"\n<p>The Central Drugs Standard Control Organisation is the highest Indian regulatory body that oversees the production of medical devices that have been approved (CDCSO). In India, the regulatory authority is in charge of licencing and approving the production of medical devices. FORM MD-7 and FORM MD-9&nbsp;are used by this regulatory agency to issue manufacturing licences, as required by the <strong>Medical Device Rules of 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>.<\/p>\n\n\n\n<p>According to the 2017 New Medical Rules, all medical devices have been divided into four distinct categories. Class A, Class B, Class C &amp; Class D, respectively. Any company that aims to manufacture these devices for distribution and sale must submit an application to <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> for a manufacturer&#8217;s licence.<\/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\/what-is-form-md-7-and-form-md-9\/#Governing_bodies_for_Medical_Devices_in_India\" >Governing bodies for 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-2\" href=\"https:\/\/corpbiz.io\/learning\/what-is-form-md-7-and-form-md-9\/#Form_MD-7_and_Form_MD-9_Meaning\" >Form MD-7 and Form MD-9: Meaning<\/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\/what-is-form-md-7-and-form-md-9\/#What_does_the_Application_for_Manufacturing_License_Include\" >What does the Application for Manufacturing License Include?<\/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\/what-is-form-md-7-and-form-md-9\/#Validity_of_Manufacturing_License_Received_in_Form_MD-9\" >Validity of Manufacturing License Received in Form MD-9<\/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\/what-is-form-md-7-and-form-md-9\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Governing_bodies_for_Medical_Devices_in_India\"><\/span>Governing bodies for Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Both the Central Government &amp; the State Government play\nsignificant roles in the enforcement and administration of the New Medical\nDevice Rules. CDSCO coordinates with the State Government to ensure uniform\nrule enforcement.<\/p>\n\n\n\n<ul><li><strong>Central\nGovernment<\/strong>: <\/li><\/ul>\n\n\n\n<p>Central\nLicensing Authority (CLA) \u2013 Drugs Controller General of India serves as its\nhead. The CLA governs the use of FORM MD-7 and FORM MD-9. It serves the\nfollowing functions- <\/p>\n\n\n\n<ol><li>Import of All Classes of Medical Devices.<\/li><li>Production of High-Risk Medical Devices (Class C\n&amp; D).<\/li><li>Permission for medical device clinical\ninvestigation.<\/li><li>Permission for Clinical Evaluation of In-vitro\nDiagnostic Performance.<\/li><li>Authorisation of investigational medical devices\nand novel in-vitro diagnostics<\/li><li>Coordination with the State Licensing Agency.<\/li><\/ol>\n\n\n\n<ul><li><strong>State\nGovernment: <\/strong>State Licensing Authority (SLA) \u2013 State Drug Controller is in\ncharge of-<\/li><\/ul>\n\n\n\n<ol><li>Manufacturing of low-risk (Class A &amp; B) medical devices for sale or distribution.<\/li><li>&nbsp;Authorisation for the sale or distribution of all types of medical devices.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Form_MD-7_and_Form_MD-9_Meaning\"><\/span>Form MD-7 and Form MD-9: Meaning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A manufacturing licence application is made using Form MD-7\nand Form MD-9 is the licence to manufacture Class C or Class D medical devices\nfor sale or distribution. Form MD-7 is used to submit an application for a\nlicence to manufacture Class C and Class D medical devices for sale and\ndistribution, while Form MD-9 is used to obtain the licence to manufacture\nClass C and Class D medical devices.<\/p>\n\n\n\n<p>Form MD-8 must be used to submit an application for a loan\nlicence to manufacture Class C and Class D medical devices for sale and\ndistribution, and Form MD-10 can be used to obtain the loan licence to\nmanufacture Class C and Class D medical devices. Due to the high risk\nclassification of Class C and Class D medical devices, the application process\nis extremely stringent.<\/p>\n\n\n\n<p><strong>Classification of\nMedical Devices Based on their Risk Levels<\/strong><\/p>\n\n\n\n<ul><li>Class A &#8211; low risk<\/li><li>Class B \u2013 moderate to low risk<\/li><li>Class C \u2014 moderate to high risk<\/li><li>Class D &#8211; high risk<\/li><\/ul>\n\n\n\n<p>Class A\n&amp; Class B medical devices are considered low- and moderate-risk,\nrespectively. The State Licensing Authority must receive the application for\nmanufacturing medical devices belonging to these classes. Class C and Class D\ndevices are classified as High and Extremely High Risk devices, respectively.\nThe application for their production must be submitted to the Central Licensing\nAuthority.<\/p>\n\n\n\n<p>The\nmanufacturer who wishes to be granted a Loan License for the further sale and\ndistribution of class B and C medical devices must submit an online application\nthrough the Ministry of Health and Family Welfare&#8217;s online portal in the\nCentral Government, via the Central Licensing Authority, using FORM MD-7 and\nFORM MD-9.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_does_the_Application_for_Manufacturing_License_Include\"><\/span>What does the Application for Manufacturing License Include?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>A cover letter, a plant master file, and a device master file<\/li><\/ul>\n\n\n\n<ul><li> Quality Management System specified in accordance with the 5th schedule of Medical Device Rules, along with a performance evaluation report (IVDs only)<\/li><\/ul>\n\n\n\n<ul><li>Constitutional information about the organisation, the establishment\/site possession<\/li><\/ul>\n\n\n\n<ul><li>Copies of duly notarised, valid Quality Certificates for the manufacturing site<\/li><\/ul>\n\n\n\n<ul><li>Possession of a valid Test License for checking and generation of quality control data<\/li><\/ul>\n\n\n\n<ul><li>A signed undertaking stating that the manufacturing site complies with the requirements of the Fifth schedule.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_Manufacturing_License_Received_in_Form_MD-9\"><\/span>Validity of Manufacturing License Received in Form MD-9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The validity of the licence received in Form MD-9 is for a\nperiod of 5 years; it is perpetual, subject to the timely payment of the\nlicense retention fee within 5 years of the date of issuance, as per the Second\nSchedule, unless suspended or revoked by the Central Licensing Authority. In\ncase the payment is not made on time, the licence is suspended or revoked.<\/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 State Licencing Authority (Class A and Class B devices) and the Central Licencing Authority are responsible for issuing certifications (Class C and D devices). On January 1, 2018, the Medical Device Rule, the new Indian Regulation, went into effect. Every medical device must bear a Unique Device Identifier beginning January 1, 2022. (UDI). To be sold in India, medical devices must be registered with Regulatory Authority. Regarding Class A and Class B medical devices, the documentation must be submitted to State Licencing Authority, which will issue Form MD-5 certification. While documentation for Class C and Class D devices must be submitted to the Central Licencing Authority, which will issue Form MD-7, Form MD-9 (for Class C devices), and Form MD-8 (for Class D devices) (for Class D 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\/form-md-8-and-form-md-10\/\">What are Form MD-8 and Form MD-10?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drugs Standard Control Organisation is the highest Indian regulatory body that oversees the production of medical devices that have been approved (CDCSO). In India, the regulatory authority is in charge of licencing and approving the production of medical devices. FORM MD-7 and FORM MD-9&nbsp;are used by this regulatory agency to issue manufacturing licences, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46612,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2593],"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":5610,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46609"}],"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=46609"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46609\/revisions"}],"predecessor-version":[{"id":47331,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46609\/revisions\/47331"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46612"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46609"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46609"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46609"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}