{"id":46418,"date":"2022-08-09T12:02:54","date_gmt":"2022-08-09T06:32:54","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46418"},"modified":"2022-08-25T11:18:59","modified_gmt":"2022-08-25T05:48:59","slug":"form-md-8-and-form-md-10","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/form-md-8-and-form-md-10\/","title":{"rendered":"What are Form MD-8 and Form MD-10?"},"content":{"rendered":"\n<p>As Per the\nMedical Devices Rules, 2017, a Loan License to Manufacture Class C &amp; Class D\nMedical Devices in Form MD-10 is mandatory to manufacture notified medical\ndevices in India. These loan license applications are filed in Form MD-8 and to\nobtain the loan licenses in Form MD-10. To obtain a loan license to manufacture\nClass C &amp; D medical devices, the manufacturer has to apply to the Central\nLicensing Authority via an online portal of the Central Government. It will\ntake between 4 to 5 months to complete the procedure. In this article, we will\nfocus on Form MD-8 and Form MD-10.<\/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\/form-md-8-and-form-md-10\/#Classification_of_Medical_Device\" >Classification of Medical\nDevice<\/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\/form-md-8-and-form-md-10\/#Purpose_of_the_Form_MD-8_and_Form_MD-10\" >Purpose of the Form MD-8 and\nForm MD-10<\/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\/form-md-8-and-form-md-10\/#An_Overview_of_CDSCO\" >An Overview of CDSCO<\/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\/form-md-8-and-form-md-10\/#Documents_for_Loan_License_to_Manufacture_under_Form_MD-8_and_Form_MD-10\" >Documents for Loan License to\nManufacture under Form MD-8 and Form MD-10<\/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\/form-md-8-and-form-md-10\/#Procedure_to_obtain_Loan_License_to_Manufacture_under_Form_MD-8_and_Form_MD-10\" >Procedure to obtain Loan\nLicense to Manufacture under Form MD-8 and Form MD-10<\/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\/form-md-8-and-form-md-10\/#Validity\" >Validity<\/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\/form-md-8-and-form-md-10\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Device\"><\/span>Classification of Medical\nDevice<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>International\n  Classification<\/strong>\n  <\/td><td>\n  <strong>Risk Level<\/strong>\n  <\/td><td>\n  <strong>examples<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class A<\/strong>\n  <\/td><td>\n  Low\n  <\/td><td>\n  Tongue Depressors, Thermometers\n  <\/td><\/tr><tr><td>\n  <strong>Class B<\/strong>\n  <\/td><td>\n  Low Moderate\n  <\/td><td>\n  Hypodermic Needles, Suction Equipment\n  <\/td><\/tr><tr><td>\n  <strong>Class C<\/strong>\n  <\/td><td>\n  High Moderate\n  <\/td><td>\n  Lung Ventilator, Bone Fixation\n  <\/td><\/tr><tr><td>\n  <strong>Class D<\/strong>\n  <\/td><td>\n  High\n  <\/td><td>\n  Heart Valves, Implantable Devices\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Purpose_of_the_Form_MD-8_and_Form_MD-10\"><\/span>Purpose of the Form MD-8 and\nForm MD-10<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>MD-8:<\/strong> Application for issue of loan license to manufacture for distribution or sale of Class C &amp; D <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device<\/strong><\/a>.<\/li><li><strong>MD-10:<\/strong> Loan License to manufacture for distribution or sale of Class C &amp; D medical devices.<\/li><\/ul>\n\n\n\n<p><strong><em>Note:\nThe applicant&#8217;s manufacturing site needs must comply with the requirements of\nthe Fifth Schedule of the Quality Management System. <\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"An_Overview_of_CDSCO\"><\/span>An Overview of CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO stand\nfor Central Drugs Standard Control Organisation under the Directorate General of\nHealth Services, the Ministry of Health &amp; Family Welfare, and the\nGovernment of India is India&#8217;s NRA (National Regulatory Authority). It is\nheadquartered at FDA Bhawan, Kotla road, New Delhi and has six zonal offices,\nfour sub-zonal offices, thirteen port offices &amp; seven labs spread in the\ncountry. Under the Drugs &amp; Cosmetics Act, CDSCO is responsible for approval\nof new drugs, laying down the standards for drugs, the conduct of clinical\ntrials, control over the quality of imported drugs in the country and\ncoordinating the activities of State Drugs Control Organizations by providing\nexpert suggestion with a view of bringing the uniformity in the enforcement of\nthe Drugs &amp; Cosmetics Act.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_for_Loan_License_to_Manufacture_under_Form_MD-8_and_Form_MD-10\"><\/span>Documents for Loan License to\nManufacture under Form MD-8 and Form MD-10<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some vital documents for Loan License to Manufacture of medical devices under Form MD-8 and Form MD-10:<\/p>\n\n\n\n<ul><li>Covering Letter;<\/li><li>Application Form;<\/li><li>Receipt of fees challan;<\/li><li>Documents of Site ownership or Tenancy\nagreement;<\/li><li>Constitution of the firm, including<\/li><li>MOA &amp; AOA or Partnership deed.<\/li><li>List all Partners &amp; Directors with complete\npostal, age &amp; address.<\/li><li>Declaration of\nPartners\/Proprietor\/Directors\/Managing Director.<\/li><li>Device Master file for all products (according\nto appendix II\/ appendix III of the Fourth Schedule);<\/li><li>Copy of Test License (if applicable);<\/li><li>Plant Master File (according to appendix I of\nPart III of the Fourth Schedule)<\/li><li>Apart from the mandatory information according\nto appendix I of Part III of the Fourth Schedule, the following are the\ndocuments that should also be submitted:<\/li><li>Declaration of Analytical Chemist.<\/li><li>Declaration of Manufacturing Chemist.<\/li><li>Registration from District Industries Centre.<\/li><li>Documents of education qualification, experience\n&amp; approval certificates of proposed Manufacturing Chemist &amp; Analytical\nChemist; Appointment Letters; Id proof.<\/li><li>Consent to establish &amp; consent to operate\nfrom State Pollution Control Board<\/li><li>Performance Evaluation Report (if applicable);<\/li><li>An undertaking in which the manufacturing Site\ncomplies with the provisions of Schedule IV.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_obtain_Loan_License_to_Manufacture_under_Form_MD-8_and_Form_MD-10\"><\/span>Procedure to obtain Loan\nLicense to Manufacture under Form MD-8 and Form MD-10<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the process to obtain Loan License to manufacture class C &amp; D medical devices in India- Form MD-8 and Form MD-10:<\/p>\n\n\n\n<p><strong>Step 1: <\/strong>Sugam Registration of the\napplicant.<\/p>\n\n\n\n<p><strong>Step 2:<\/strong> Drafting of application.<\/p>\n\n\n\n<p><strong>Step 3:<\/strong> Upload all the documents as per\nForm MD-8.<\/p>\n\n\n\n<p><strong>Step 4:<\/strong> Processing the compulsory\ngovernment fee.<\/p>\n\n\n\n<p><strong>Step 5:<\/strong> Applying the online medical\ndevice portal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity\"><\/span>Validity<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The license\ngrant in Form MD-10 will remain valid permanently, for the retention fee\nspecified in Schedule II is paid before completion of five years from the date\nof grant unless the Central Licensing Authority suspends\/cancels the license. <\/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 <strong>Drug Controller General of India (DCGI)<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_Controller_General_of_India\"><strong>[1]<\/strong><\/a><\/sup> oversees all medical devices as part of the Ministry of Health and Family Welfare&#8217;s Central Drugs Standard Control Organization (CDSCO).<\/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\/what-is-form-md-4-and-form-md-6\/\">What is FORM MD-4 and FORM MD-6?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As Per the Medical Devices Rules, 2017, a Loan License to Manufacture Class C &amp; Class D Medical Devices in Form MD-10 is mandatory to manufacture notified medical devices in India. These loan license applications are filed in Form MD-8 and to obtain the loan licenses in Form MD-10. To obtain a loan license to [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":46419,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2582],"acf":{"service_id":"385"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":4795,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46418"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46418"}],"version-history":[{"count":19,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46418\/revisions"}],"predecessor-version":[{"id":47341,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46418\/revisions\/47341"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46419"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46418"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46418"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46418"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}