{"id":12322,"date":"2022-11-02T11:23:27","date_gmt":"2022-11-02T11:23:27","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=12322"},"modified":"2022-11-02T11:23:29","modified_gmt":"2022-11-02T11:23:29","slug":"what-is-the-meaning-of-form-md-7-and-form-md-9","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/","title":{"rendered":"What is the Meaning of FORM MD-7 and FORM MD-9?"},"content":{"rendered":"\n<p>A person or a company involved in the manufacturing of Medical Devices in India can distribute\/communicate the products by applying through the concerned Authority. The application process includes applying for a Loan, grant, or License to distribute or sell the devices in India. Under <strong><em>Medical Devices Rules, 2017<\/em><\/strong>, a Manufacturing License to Manufacture Class C &amp; D Medical Devices is granted in Form MD-9. These Manufacturing License applications are filed in Form MD-7 and used to get the Licenses in Form MD-9. To get a Manufacturing License to Manufacture Class C &amp; D Medical Devices in India, the manufacturer must apply to the concerned Authority. In this blog, we will discuss the meaning of Form MD-7 and Form MD-9.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3a8c9d565e8\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3a8c9d565e8\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#What_is_the_Purpose_of_Form_MD-7_and_Form_MD-9\" title=\"What is the Purpose of Form\nMD-7 and Form MD-9?\">What is the Purpose of Form\nMD-7 and Form MD-9?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#CDSCO_Risk-based_Classification_of_Medical_Devices_in_India\" title=\"CDSCO Risk-based Classification\nof Medical Devices in India\">CDSCO Risk-based Classification\nof 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:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#Checklist_for_Loan_License_to_Manufacture_Class_C_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\" title=\"Checklist for Loan License to\nManufacture Class C &amp; D Medical Devices under Form MD-7 and Form MD-9\">Checklist for Loan License to\nManufacture Class C &amp; D Medical Devices under Form MD-7 and Form MD-9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#Procedure_for_Obtaining_Loan_License_to_Manufacture_Class_C_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\" title=\"Procedure for Obtaining Loan\nLicense to Manufacture Class C &amp; D Medical Devices under Form MD-7 and Form\nMD-9\">Procedure for Obtaining Loan\nLicense to Manufacture Class C &amp; D Medical Devices under Form MD-7 and Form\nMD-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:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#Validity_of_the_Loan_License_Received_in_Form_MD-9\" title=\"Validity of the Loan License\nReceived in Form MD-9\">Validity of the Loan License\nReceived 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-6\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#Conditions_of_Manufacturing_License_to_Manufacture_Class_C_or_Class_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\" title=\"Conditions of Manufacturing\nLicense to Manufacture Class C or Class D Medical Devices under Form MD-7 and Form\nMD-9\">Conditions of Manufacturing\nLicense to Manufacture Class C or Class D Medical Devices under Form MD-7 and Form\nMD-9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-meaning-of-form-md-7-and-form-md-9\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_Purpose_of_Form_MD-7_and_Form_MD-9\"><\/span>What is the Purpose of Form\nMD-7 and Form MD-9?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li><strong>Form\nMD-7<\/strong>:\nThis is the application for the grant of a Manufacturing License to distribute\nor sell Class C and Class D Medical Devices in India.<\/li><li><strong>Form\nMD-9<\/strong>:\nThis is the Manufacturing License to manufacture for distribution or sale of\nClass C and Class D Medical Devices in India.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Risk-based_Classification_of_Medical_Devices_in_India\"><\/span>CDSCO Risk-based Classification\nof Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical\nDevices in India have usually based on risks; the risk-based classification of\nMedical Devices in India depends upon their intended use &amp; purpose. The\nfollowing is the risk-based classification of Medical Devices in India:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Class<\/strong>\n  <\/td><td>\n  <strong>Risk<\/strong>\n  <\/td><td>\n  <strong>Medical\n  Devices<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  A<\/strong>\n  <\/td><td>\n  Low Risk\n  <\/td><td>\n  Surgical dressing, alcohol swabs, absorbent,\n  etc.\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  B<\/strong>\n  <\/td><td>\n  Low Moderate Risk\n  <\/td><td>\n  BP Monitoring Device, Thermometer,\n  Disinfectants, etc.\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  C<\/strong>\n  <\/td><td>\n  Moderate High-Risk\n  <\/td><td>\n  Haemodialysis catheter, Implants, etc.\n  <\/td><\/tr><tr><td>\n  <strong>Class\n  D<\/strong>\n  <\/td><td>\n  High Risk\n  <\/td><td>\n  Heart valve, angiographic guide wire, etc.\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>In\nIndia, Medical Devices are categorised into 4 categories depending upon the\nindication of risk level and device use. Class A, B, C &amp; D have been set up\nunder the new system, where Class A &amp; Class B Medical Devices present the\nleast risk and Class C or Class D Medical Devices present higher risks to\npatients. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_for_Loan_License_to_Manufacture_Class_C_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\"><\/span>Checklist for Loan License to\nManufacture Class C &amp; D Medical Devices under Form MD-7 and Form MD-9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the checklist for Loan License to Manufacture Class C &amp; D Medical\nDevices under Form MD-7 and Form MD-9:<\/p>\n\n\n\n<ol><li>Covering Letter;<\/li><li>Constitution of the Firm;<\/li><li>Site Ownership or Establishment or Tenancy\nAgreement;<\/li><li>Copy of Certificate supporting QMS (Quality\nManagement System) (ISO:13485), if any;<\/li><li>Plant Layout of the premise with an indication\nof scale;<\/li><li>QMS as per 5<sup>th<\/sup> Schedule of MDR, 2017;<\/li><li>Quality Manual and Quality Policy;<\/li><li>Control of Documents and Control of Records;<\/li><li>Management Responsibility;<\/li><li>Internal\nAudit System;<\/li><li>Preventive &amp; Corrective Action;<\/li><li>Procedure\nfor identifying training needs &amp; make sure that all individuals are trained\nto adequately perform their assigned responsibilities;<\/li><li>Test\nLicense obtained for testing &amp; generation of quality control data;<\/li><li>Undertaking\nsigned stating that the manufacturing site is in compliance with the provision\nof the 5<sup>th<\/sup> Schedule;<\/li><li>Fee challan.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Obtaining_Loan_License_to_Manufacture_Class_C_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\"><\/span>Procedure for Obtaining Loan\nLicense to Manufacture Class C &amp; D Medical Devices under Form MD-7 and Form\nMD-9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the procedure for obtaining Loan License to Manufacture Class C &amp; D\nMedical Devices under Form MD-7 and Form MD-9:<\/p>\n\n\n\n<p><strong>Step 1:<\/strong> First, the applicant should register with <strong>the Ministry of Health &amp; Family Welfare<\/strong><sub><a href=\"https:\/\/services.india.gov.in\/service\/ministry_services?ln=en&amp;cmd_id=1338\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sub>.<\/p>\n\n\n\n<p><strong>Step 2:<\/strong> Then, the applicant\nneeds to apply for Loan License for Class C or Class D medical devices in Form\nMD-7 with all the relevant documents.<\/p>\n\n\n\n<p><strong>Step 3:<\/strong> The forms should be\nuploaded along with the fee, as mentioned in the 2<sup>nd<\/sup> Schedule of\nPart II.<\/p>\n\n\n\n<p><strong>Step 4:<\/strong> Upload all the relevant\ninformation as per sub-rule-(1);<\/p>\n\n\n\n<p><strong>Step 5:<\/strong> After submitting all\nthe vital documents, the CLA will probe the application.<\/p>\n\n\n\n<p><strong>Step 6:<\/strong> Upon approval of the\nLicense, the Authority shall provide the License through Form MD-9.<\/p>\n\n\n\n<p><strong>Step 7:<\/strong>Upon rejection of the\napplication, the applicant shall file again to the Authority within 45 days\nwith all the relevant documents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_the_Loan_License_Received_in_Form_MD-9\"><\/span>Validity of the Loan License\nReceived in Form MD-9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nvalidity of the Loan License received in Form MD-9 is for 5 years. In the case\nof the License being cancelled\/suspended, the applicant shall apply within\nforty-five days from the date of the action.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_of_Manufacturing_License_to_Manufacture_Class_C_or_Class_D_Medical_Devices_under_Form_MD-7_and_Form_MD-9\"><\/span>Conditions of Manufacturing\nLicense to Manufacture Class C or Class D Medical Devices under Form MD-7 and Form\nMD-9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nfollowing are the conditions for Manufacturing License to Manufacture Class C\nor Class D Medical Devices under Form MD-7 and Form MD-9:<\/p>\n\n\n\n<ol><li>The License should be produced when requested by the Medical Device Office\/any other senior officials from the CLA or SLA;<\/li><li>The License Holder should request approval before making any changes. The request should be applied, as mentioned in the 6<sup>th<\/sup> Schedule. After approval, the License Holder shall detail the information within 45 days to the CLA or SLA;<\/li><li>All the audits must be documented;<\/li><li>The License holder should maintain records of manufacturing &amp; and sales should be produced when required by the Medical Officer;<\/li><li>In case the manufacturer of the Medical Device stopped manufacturing the devices for more than 30 days, then the relevant information should be informed to the CLA or SLA;<\/li><li>If any suspected unexpected serious adverse event, the License Holder should inform the CLA or SLA and inform about the action taken within 15 days;<\/li><li>According to sub-rule (3) of Rule 83, the License Holder should perform tests in the lab before releasing the products. All the test documents should be submitted in the SLA or CLA;<\/li><li>All the test samples must be preserved for 180 days after expiry.<\/li><\/ol>\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>In India, the main regulatory body for Medical Devices in India is the CDSCO and its top representative is the DCGI (Drug Controller General of India). The DCGI or Drug Controller General of India is in charge of approving the manufacturing of Medical Devices. Manufacturers &amp; sellers of Medical Devices need to get a <strong><a class=\"text-primary\" href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\">CDSCO License<\/a><\/strong>. Applications for Manufacturing Licenses to Manufacture Class C &amp; D Devices for sale or distribution should be submitted online using Form MD-7 and Form MD-9 along with a fee.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/what-is-the-purpose-of-form-md-3-and-form-md-5\/\">What is the Purpose of Form MD-3 and Form MD-5?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A person or a company involved in the manufacturing of Medical Devices in India can distribute\/communicate the products by applying through the concerned Authority. The application process includes applying for a Loan, grant, or License to distribute or sell the devices in India. Under Medical Devices Rules, 2017, a Manufacturing License to Manufacture Class C [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":12331,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12322"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=12322"}],"version-history":[{"count":7,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12322\/revisions"}],"predecessor-version":[{"id":12333,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12322\/revisions\/12333"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/12331"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=12322"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=12322"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=12322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}