{"id":11879,"date":"2022-09-08T06:08:34","date_gmt":"2022-09-08T06:08:34","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11879"},"modified":"2022-09-08T06:14:48","modified_gmt":"2022-09-08T06:14:48","slug":"cdsco-medical-device-loan-license","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/cdsco-medical-device-loan-license\/","title":{"rendered":"CDSCO Medical Device Loan License"},"content":{"rendered":"\n<p>The Ministry of health and family welfare (MoHFW) and the CDSCO have enacted the rules of the Medical device, 2017. The rules have been created to make sure that only those medical devices that meet quality and safety control standards are used in the healthcare industry. The rules also classify the medical devices as per the risk it poses; this lets the patient have access to safe and quality medical devices. The rules have also made it mandatory for manufacturers and importers to get registered and obtain a license for manufacturing. In case the manufacturer requires a loan, he has to fill in the form MD-4 &amp; 8 for &#8216;Medical device Loan license&#8217;. This article shall try to educate the reader about Medical device Loan licenses in India.<\/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-6a3a8c9f2e854\" 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-6a3a8c9f2e854\"  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\/cdsco-medical-device-loan-license\/#What_are_the_important_forms_for_Medical_Device_Loan_License\" title=\"What are the important forms for Medical Device Loan\nLicense?\">What are the important forms for Medical Device Loan\nLicense?<\/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\/cdsco-medical-device-loan-license\/#Which_authorities_are_responsible_for_granting_the_Medical_device_Loan_License\" title=\"Which authorities are responsible for granting the Medical device Loan License?\">Which authorities are responsible for granting the Medical device Loan License?<\/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\/cdsco-medical-device-loan-license\/#Documentation_required_for_grant_of_Medical_device_Loan_License\" title=\"Documentation required for grant of Medical device Loan\nLicense\">Documentation required for grant of Medical device Loan\nLicense<\/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\/cdsco-medical-device-loan-license\/#Process_of_applying_for_Medical_device_loan_license\" title=\"Process of applying for Medical device loan license\">Process of applying for Medical device loan 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:\/\/swaritadvisors.com\/blog\/cdsco-medical-device-loan-license\/#Validity_of_the_Medical_device_loan_license\" title=\"Validity of the Medical device loan license\">Validity of the Medical device loan license<\/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\/cdsco-medical-device-loan-license\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_important_forms_for_Medical_Device_Loan_License\"><\/span>What are the important forms for Medical Device Loan\nLicense?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  S.no\n  <\/td><td>\n  Description\n  <\/td><td>\n  Application form\n  <\/td><td>\n  Approval form\n  <\/td><td>\n  Fees\n  <\/td><td>\n  Rule\n  <\/td><td>\n  Licensing Authority\n  <\/td><\/tr><tr><td>\n  1.\n  <\/td><td>\n  Manufacturing licence or loan License for Class A or\n  Class B medical device\n  <\/td><td>\n  MD- 3 (for license)\n  MD-4 (for loan)\n  <\/td><td>\n  MD- 5 (for license)\n  MD-6 (for loan)\n  <\/td><td>\n  \u20b95000- registration of one\n  plant\/site\u20b9500 for registration of one\n  product\n  \n  <\/td><td>\n  20 (2) and 20(4)\n  <\/td><td>\n  State licensing Authority\n  <\/td><\/tr><tr><td>\n  2.\n  <\/td><td>\n  Manufacturing licence or loan licence to manufacture\n  Class C or Class D medical device\n  <\/td><td>\n  MD- 7 (for license)\n  MD- 8 (for loan)\n  <\/td><td>\n  MD- 9 (for license)\n  MD-10\n  (for Loan)\n  <\/td><td>\n  \u20b950,000- registration of one\n  plant\/site\u20b91000 for registration of one\n  product\n  \n  <\/td><td>\n  21(2) and&nbsp; 25\n  (1)\n  <\/td><td>\n  Central licensing Authority\n  <\/td><\/tr><tr><td>\n  3.\n  <\/td><td>\n  Manufacturing licence or loan licence retention feeClass\n  A, Class B, Class C, Class D medical device\n  <\/td><td>\n  N\/A\n  <\/td><td>\n  MD-5, MD-6,<br>\n  MD-9,\n  MD-10\n  <\/td><td>   The retention fee is the same as   above, however, this must be paid every 5 years    <\/td><td>\n  29\n  <\/td><td>\n  State Licensing Authority and Central Licensing\n  Authority\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Which_authorities_are_responsible_for_granting_the_Medical_device_Loan_License\"><\/span>Which authorities are responsible for granting the Medical device Loan License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There are two authorities that grant loan\nlicenses as per Medical device rules these are:<\/p>\n\n\n\n<ul><li><strong>State licensing Authorities (SLA):<\/strong> authorities are set by the respective state government to issue medical licenses. It is the notified body that shall audit the manufacturing site of Class A and Class B medical devices. SLAs also provide manufacturing licenses, medical device loan licenses, and retention licenses to products that fall under categories A and B. It also has the power to suspend the entity&#8217;s licenses if they are not up to the standards set by medical device rules.<\/li><li><strong>Central Licensing Authorities (CLA):<\/strong> CLA is established by the Drugs Controller General of India. It is the notified body that conducts, analyses and sets performance parameters for devices that fall under Class C and D. Moreover, it is the authority responsible for granting import licenses to Devices of all the categories from A-D. The Central licensing authority can also revoke the license of anyone if they are found flouting the rules or guidelines. Numerous times CLA and the SLA work together to ensure effective implication of the medical device rules in the country.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documentation_required_for_grant_of_Medical_device_Loan_License\"><\/span>Documentation required for grant of Medical device Loan\nLicense<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A comprehensive list of documents is to be submitted along with the prescribed forms for the Medical device Loan License. These are:<\/p>\n\n\n\n<ul><li>A cover letter<\/li><li>The Challan of the amount paid as per the medical device<\/li><li>Relevant declarations to be made as per Affidavit-1 shall include information such as partners, proprietors, directors etc.<\/li><li>An attested copy of the MoA, Partnership or Pan card (as applicable) is to be attached with the Affidavit<\/li><li>A Duly notarized document with the name, address and details of the required members that carry out day-to-day activities of the enterprise. This along with photographs and conduct of the business.<\/li><li>A letter of consent from the parent company ratifying the availability of resources and license details. <strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\">CDSCO Loan license<\/a><\/strong> if already issued<\/li><li>Details and declaration of the technical staff that is involved in the process of  production for analysis purposes<\/li><li>Details of any previous applied\/ issued CDSCO loan license of the company.<\/li><li>Declaration  regarding any formulations that were not applicable earlier or were prohibited by the authority due to association with the same\/ different brand name<\/li><li>Packing  details with all the list of formulations <\/li><li>Labels  for all the specimens<\/li><li>Test methods opted for ingredients and products that are not in pharmacopoeia and any other Compendia of drug standards<\/li><li>Copy of  monograph for drugs that are not present in I.P<\/li><li>A flow chart showing the production procedure with consumption co-efficient and effluents needed for the treatment<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_of_applying_for_Medical_device_loan_license\"><\/span>Process of applying for Medical device loan license<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>The applicant must be registered with the Ministry of health and family welfare.<\/li><li>The  applicant must apply through the appropriate form, i.e. MD-4 for medical  devices of class A &amp; B and MD-8 for devices of class C&amp;D<\/li><li>Next, the applicant must upload the form on the <strong>sugam portal<\/strong><sup><a href=\"https:\/\/sugam.odisha.gov.in\/website\/home\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>, as per the guidelines.  The applicant must ensure that all the relevant information is provided.<\/li><li>After this, the applicant must also upload all the prescribed documents.<\/li><li>Once the form is uploaded, the State licensing authority or the Central licensing authority shall scrutinise the application.<\/li><li>If the authorities approve, then the loan license shall be granted through forms MD-6 and MD-10.<\/li><li>In case the application is rejected, then the entity may file for the same after  45 days.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_the_Medical_device_loan_license\"><\/span>Validity of the Medical device loan license<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical device loan license shall be\nvalid for a lifetime. However, the applicant needs to pay the retention fee at\nthe interval of five years. The failure to pay this shall make the license\ninvalid\/ cancelled. The entity may file an appeal in the next 45 days with SLA\nor CLA in such cases.<\/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> Medical device rules 2017 have a provision for manufacturers to apply for a medical device loan license. Entities must apply for this license if they do not have their own sterilisation facility and use other brands. Or if they want to sell or distribute medical devices through the online system of the medical devices portal. <\/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-forms-md-14-and-md-15\/\">What is Forms MD-14 and MD-15<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of health and family welfare (MoHFW) and the CDSCO have enacted the rules of the Medical device, 2017. The rules have been created to make sure that only those medical devices that meet quality and safety control standards are used in the healthcare industry. The rules also classify the medical devices as per [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11883,"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\/11879"}],"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\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=11879"}],"version-history":[{"count":6,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11879\/revisions"}],"predecessor-version":[{"id":11888,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11879\/revisions\/11888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11883"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}