{"id":46322,"date":"2022-08-08T11:27:44","date_gmt":"2022-08-08T05:57:44","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46322"},"modified":"2022-08-25T11:21:44","modified_gmt":"2022-08-25T05:51:44","slug":"what-is-form-md-4-and-form-md-6","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-is-form-md-4-and-form-md-6\/","title":{"rendered":"What is FORM MD-4 and FORM MD-6?"},"content":{"rendered":"\n<p>According to the <strong>Medical Devices 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>, any business seeking a loan licence to produce Class A or Class B medical devices must submit an application. In vitro diagnostic devices may also be categorised as Class A or Class B medical devices because they are low and low-to-moderate risk devices. The manufacturer must submit an online application through the Ministry of Health and Family Welfare&#8217;s online portal via the State Licensing Authority, using Form MD-4 and Form MD-6, in order to be granted a Loan License for the continued sale and distribution of class A and Class&nbsp;B medical devices. Form MD-4 may be used to apply for a Loan License to Manufacture for Sale or Distribution of a Class A or Class B medical device. In this write-up, we will discuss Form MD-4 and Form MD-6.<\/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-4-and-form-md-6\/#Regulatory_Bodies\" >Regulatory Bodies<\/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-4-and-form-md-6\/#Classification_of_Medical_Devices_in_India\" >Classification of 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-3\" href=\"https:\/\/corpbiz.io\/learning\/what-is-form-md-4-and-form-md-6\/#Form_MD-4_and_Form_MD-6_Meaning\" >Form MD-4 and Form MD-6: Meaning<\/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-4-and-form-md-6\/#What_is_a_Medical_Device_Manufacturing_License\" >What is a Medical Device Manufacturing 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\/what-is-form-md-4-and-form-md-6\/#Requirements_for_Granting_a_Manufacturing_or_Loan_License_through_Form_MD-4_and_Form_MD-6\" >Requirements for Granting a Manufacturing or Loan\nLicense through Form MD-4 and Form MD-6<\/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\/what-is-form-md-4-and-form-md-6\/#Application_Procedure_for_Class_A_and_Class_B_License_Grants_Loans_%E2%80%93_Form_MD-4_and_Form_MD-6\" >Application Procedure for Class A and Class B License Grants Loans &#8211; Form\nMD-4 and Form MD-6<\/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\/what-is-form-md-4-and-form-md-6\/#Validity_of_a_License\" >Validity of a License<\/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\/what-is-form-md-4-and-form-md-6\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Bodies\"><\/span>Regulatory Bodies<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Depending on the category of\nmedical device, the regulatory responsibilities have been split between the\nState and Central Governments. The State Licensing Authority (SLA) is in charge\nof overseeing the production of Class A and B medical device through FORM MD-4\nand FORM MD-6. All four classes of devices will be sold and distributed under its\nsupervision.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_in_India\"><\/span>Classification of Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical devices are classified into the following 4 categories based\non the risk involved in usage:<\/p>\n\n\n\n<ul><li>Class A: Low risk devices<\/li><li>Class B: Low to moderate risk devices <\/li><li>Class C: Moderate to high risk devices <\/li><li>Class D: High risk devices <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Form_MD-4_and_Form_MD-6_Meaning\"><\/span>Form MD-4 and Form MD-6: Meaning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Applications and permits for the sale and\ndistribution of medical devices are submitted using FORM MD-4 and FORM\nMD-6&nbsp;respectively. While Form MD-6 provides Loan Licence to manufacture\nfor sale or distribution of Class A or Class B Medical Device. Form MD-4 is\nused as an application for grant of Loan licence to manufacture for sale or\ndistribution of Class A\/Class B Medical Device.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_a_Medical_Device_Manufacturing_License\"><\/span>What is a Medical Device Manufacturing License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A medical device manufacturer or\ndistributor can apply for state licencing through the State Licensing Authority\nto sell or distribute their products. The application procedure entails\nrequesting a grant, loan, or licence to sell or distribute. In accordance with\nthe Medical Devices Rules, 2016, the application and licence may be submitted\nonline through Form MD-4 and Form MD-6&nbsp;at the Ministry of Health and\nFamily Welfare. Class A and&nbsp;Class B, medical devices fall under this\ncategory.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirements_for_Granting_a_Manufacturing_or_Loan_License_through_Form_MD-4_and_Form_MD-6\"><\/span>Requirements for Granting a Manufacturing or Loan\nLicense through Form MD-4 and Form MD-6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The holder of a licence must adhere to the following conditions after\nreceiving a grant of licence or loan licence through Form MD-4 and Form MD-6:<\/p>\n\n\n\n<ul><li>When the Medical Device Officer or any other senior official from the Central Licensing Authority or State Licensing Authority requests it, the licence must be produced.<\/li><\/ul>\n\n\n\n<ul><li>The licence holder should notify the State Licensing Authority or the Central Licensing Authority of any suspected unexpected serious adverse event and inform them of the action taken within 15 days.<\/li><\/ul>\n\n\n\n<ul><li>Before making any significant changes, the licence holder should get permission. The Sixth Schedule specifies that the request be implemented. Following approval, the licence holder must provide the information to the State Licensing Authority or Central Licensing Authority within 45 days.<\/li><\/ul>\n\n\n\n<ul><li>In accordance with rule 83&#8217;s sub-rule (3), the licence holder must conduct laboratory tests prior to releasing the products. The Central Licensing Authority or the State Licensing Authority should receive all test documentation.<\/li><\/ul>\n\n\n\n<ul><li>Form MD-11 must contain documentation for every audit.<\/li><\/ul>\n\n\n\n<ul><li>Following expiration, all test samples must be stored for 180 days.<\/li><\/ul>\n\n\n\n<ul><li>The licence holder must keep track of sales and manufacturing, and must appear when the medical officer requests it.<\/li><\/ul>\n\n\n\n<ul><li>The Central Licensing Authority or the State Licensing Authority should be notified if the medical device manufacturer stopped producing the devices for more than 30 days.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_Procedure_for_Class_A_and_Class_B_License_Grants_Loans_%E2%80%93_Form_MD-4_and_Form_MD-6\"><\/span>Application Procedure for Class A and Class B License Grants Loans &#8211; Form\nMD-4 and Form MD-6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li>The applicant must register with the Ministry of\nHealth and Family Welfare.<\/li><li>To submit an application for a licence, the\napplicant must upload the Form MD-3 with all required information.<\/li><li>To submit an application for a loan licence, the\napplicant must upload the Form MD-4 with all necessary information. As stated\nin the Second Schedule of Part II, the form must be uploaded along with the\nfee.<\/li><li>In accordance with the applicable sub-rule, all\nrelevant details must be uploaded.<\/li><li>The applicant must upload the necessary\npaperwork before submitting the undertaking as specified by the Quality\nManagement System.<\/li><li>The State Licensing Authority shall investigate\nthe submitted application.<\/li><li>The State Licensing Authority must issue the\nmanufacturing licence in Form MD-5 after probing.<\/li><li>The State Licensing Authority must provide the\nloan licence in the form MD-6.<\/li><li>The State Licensing Authority must send a\nwritten notice to the applicant within 45 days if the licence is rejected.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_a_License\"><\/span>Validity of a License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If the licence is not revoked or\nsuspended by the State Licensing Authority, the validity of a licence that was\nissued in Form MD-4 and Form MD-6 will continue to be valid for an infinite\namount of time, provided that the licence maintenance fee is paid in accordance\nwith the Second Schedule before the end of the period of five years that begins\non the date the licence was issued.<\/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 primary regulatory body for medical devices in India is the Central Drug Standards Control Organization (CDSCO). The CDSCO&#8217;s top representative is the Drug Controller General of India (DCGI). The DCGI is in charge of approving the production of medical devices. It is necessary for manufacturers and sellers of medical devices to have a<a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong> CDSCO licence<\/strong><\/a>. Each country has a dedicated oversight body under the ministry of health to look after each component of medical devices. Applications for licences to produce Class A and B devices for distribution or sale should be submitted online using Form MD- 3 or Form MD- 4 (for loan licences), along with a fee. The Form MD-5 or Form MD- 6 will be used to apply for the licence (for loan 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\/form-md-3-and-form-md-5\/\">What is FORM MD-3 and FORM MD-5?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>According to the Medical Devices Rules of 2017[1], any business seeking a loan licence to produce Class A or Class B medical devices must submit an application. In vitro diagnostic devices may also be categorised as Class A or Class B medical devices because they are low and low-to-moderate risk devices. The manufacturer must submit [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46323,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2575],"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":6176,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46322"}],"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=46322"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46322\/revisions"}],"predecessor-version":[{"id":47347,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46322\/revisions\/47347"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46323"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46322"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46322"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}