{"id":11848,"date":"2022-09-07T06:20:49","date_gmt":"2022-09-07T06:20:49","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11848"},"modified":"2022-09-07T06:33:52","modified_gmt":"2022-09-07T06:33:52","slug":"what-is-forms-md-14-and-md-15","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/what-is-forms-md-14-and-md-15\/","title":{"rendered":"What is Forms MD-14 and MD-15"},"content":{"rendered":"\n<p>Central Drugs Standard Control Organisation (CDSCO) is the authority that works under the Directorate General of Health Services. CDSCO is responsible for permitting new medicines, creating rules\/ regulations, monitoring the effectiveness of the drugs and being in coordination with the state authorities in matters related to healthcare. Another essential function of CDSCO is that it also grants certification for the import and export of medical equipment; for this, the manufacturer\/ importer needs to acquire Form MD-14 and MD-15. This article shall throw light on what is Forms MD-14 and MD-15.<\/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-6a3aa408e563d\" 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-6a3aa408e563d\"  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-forms-md-14-and-md-15\/#Form_MD-14_and_MD-15_Meaning\" title=\" Form MD-14 and MD-15: Meaning\"> Form MD-14 and MD-15: Meaning<\/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-forms-md-14-and-md-15\/#Which_authorities_are_involved_in_granting_licenses_under_Form_MD-14_and_MD-15\" title=\"Which authorities are involved in granting licenses under Form MD-14 and MD-15\">Which authorities are involved in granting licenses under Form MD-14 and MD-15<\/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-forms-md-14-and-md-15\/#The_fee_to_be_paid_in_Form_MD-14\" title=\"The fee to be paid in Form MD-14\">The fee to be paid in Form MD-14<\/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-forms-md-14-and-md-15\/#Who_can_apply_for_import_through_Form_MD-14_and_MD-15\" title=\"Who can apply for import through Form MD-14 and MD-15?\">Who can apply for import through Form MD-14 and MD-15?<\/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-forms-md-14-and-md-15\/#Documents_required_to_obtain_a_license_in_MD-15\" title=\"Documents required to obtain a license in MD-15\">Documents required to obtain a license in MD-15<\/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-forms-md-14-and-md-15\/#The_process_to_obtain_an_import_license_as_Form_MD-15\" title=\"The process to obtain an import license as Form MD-15\">The process to obtain an import license as Form MD-15<\/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-forms-md-14-and-md-15\/#Validity_of_the_License_obtained_under_Forms_MD-14_and_MD-15\" title=\"Validity of the License obtained under Forms MD-14 and MD-15\">Validity of the License obtained under Forms MD-14 and MD-15<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/swaritadvisors.com\/blog\/what-is-forms-md-14-and-md-15\/#Conclusion\" title=\"Conclusion \">Conclusion <\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Form_MD-14_and_MD-15_Meaning\"><\/span> Form MD-14 and MD-15: Meaning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If any person wishes to import devices that\nfall under the category of &#8216;notified medical device&#8217;. Then he must possess Form\nMD-15 from CDSCO. If the applicant doesn&#8217;t have the import license, then he\nneeds to file an application to the CDSCO via Form MD-14. The applicant can\nobtain this license through an authorised Indian representative who shall file\nthe application on his behalf.<\/p>\n\n\n\n<ul><li><strong>MD-14:<\/strong> the applicant fills in this form,\nalong with requisite fees and documents, to obtain an import license.<\/li><li><strong>MD-15:<\/strong> The applicant obtains the import\nlicense in Form- MD-15 for the import of medical devices from Class A-D<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Which_authorities_are_involved_in_granting_licenses_under_Form_MD-14_and_MD-15\"><\/span>Which authorities are involved in granting licenses under Form MD-14 and MD-15<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\napplicant has to get permission from two authorities\/bodies for the grant\nimport license under Form MD-14 and MD-15; these are:<\/p>\n\n\n\n<ul><li><strong>State licensing Authority (SLA)-<\/strong> The state license authority is responsible for giving out loans, manufacturing licenses and wholesale licenses to medical devices that fall under Class A and B. <\/li><li><strong>Central Licensing Authority (CLA):<\/strong> The Central licensing authority is responsible for providing licenses for the import of medical devices in the country. CLA also assists with providing manufacturing loans to devices under categories C &amp; D.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_fee_to_be_paid_in_Form_MD-14\"><\/span>The fee to be paid in Form MD-14<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The applicant will be required to pay the\nfollowing fees to get the License MD-15<\/p>\n\n\n\n<table class=\"table table-bordered\">\n<tbody>\n<tr>\n<td colspan=\"4\" width=\"622\">\n<p style=\"text-align: center;\"><strong>License fee for Form MD-14 (other than In vitro)<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>S.no<\/p>\n<\/td>\n<td width=\"262\">\n<p>Purpose<\/p>\n<\/td>\n<td width=\"147\">\n<p>For Site<\/p>\n<\/td>\n<td width=\"159\">\n<p>For Device<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>1.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class A<\/p>\n<\/td>\n<td width=\"147\">\n<p>$1000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$500<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>2.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class B<\/p>\n<\/td>\n<td width=\"147\">\n<p>$2000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$500<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>3.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class C \/Class D<\/p>\n<\/td>\n<td width=\"147\">\n<p>$3000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$1500<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n<table class=\"table table-bordered\">\n<tbody>\n<tr>\n<td colspan=\"4\" width=\"622\">\n<p style=\"text-align: center;\"><strong>License fee for Form MD-14 (For In vitro)<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>S.no<\/p>\n<\/td>\n<td width=\"262\">\n<p>Purpose<\/p>\n<\/td>\n<td width=\"147\">\n<p>For Site<\/p>\n<\/td>\n<td width=\"159\">\n<p>For Device<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>1.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class A<\/p>\n<\/td>\n<td width=\"147\">\n<p>$1000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$10<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>2.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class B<\/p>\n<\/td>\n<td width=\"147\">\n<p>$1000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$10<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"54\">\n<p>3.<\/p>\n<\/td>\n<td width=\"262\">\n<p>Import license Class C \/Class D<\/p>\n<\/td>\n<td width=\"147\">\n<p>$3000<\/p>\n<\/td>\n<td width=\"159\">\n<p>$500<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_can_apply_for_import_through_Form_MD-14_and_MD-15\"><\/span>Who can apply for import through Form MD-14 and MD-15?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The importer must appoint an authorised Indian agent. The agent must possess a manufacturing or wholesale license in FORM 20B and 21 Bas per the<strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\"> CDSCO guidelines<\/a><\/strong>. The agent shall then apply for the license through Sugam online portal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_obtain_a_license_in_MD-15\"><\/span>Documents required to obtain a license in MD-15<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There is a comprehensive list of documents\nrequired to obtain a license in MD-15<\/p>\n\n\n\n<ul><li>A Covering letter <\/li><li>A self-attested copy of the agent&#8217;s wholesale\/ manufacturing license<\/li><li>A notarized copy of the Free sale certificate of the product as granted by the National regulatory authority of the country of origin<\/li><li>The latest copy of the audit\/ inspection report carried out by competent authority within the past three years. (if applicable)<\/li><li>Certified copy of the ISO: 13485<\/li><li>Certified copy of the CE quality assurance<\/li><li>Certified  copy of the CE design certificate<\/li><li>Plant master file <\/li><li>Device master file<\/li><li>Flow chart of device design<\/li><li>Flow  chart of the manufacturing process<\/li><li>Notarised  copy of the manufacturing site overseas<\/li><li>Power of  attorney<\/li><li>Copy of  FEE challan<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_process_to_obtain_an_import_license_as_Form_MD-15\"><\/span>The process to obtain an import license as Form MD-15<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>The applicant must evaluate the product as per the <strong>Medical device Rules 2017<\/strong><sup><a href=\"https:\/\/www.dfda.goa.gov.in\/circulars-orders-notifications\/notification\/419-medical-device-rules-2017\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>.<\/li><li>Then the applicant must log on to the Sugam portal of CDSCO with the registered ID and password.<\/li><li>Appoint the authorised agent <\/li><li>The applicant needs to fill in the required details on the portal<\/li><li>Upload  relevant documents as mentioned in the list above<\/li><li>Recheck \/Confirm the data in the draft application and submit it <\/li><li>Reply to  any query raised by the regulatory authorities<\/li><li>Medical device Import approval via Form MD-14 shall be received.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_the_License_obtained_under_Forms_MD-14_and_MD-15\"><\/span>Validity of the License obtained under Forms MD-14 and MD-15<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The validity of the license issued in Form\nMD-15 is perpetual. The applicant does not have to renew the license as long as\nthe retention fee is being paid as per the norms stated in the second schedule.\nThe retention fee must be paid in a timely manner in a span of five years from\nthe date of issue unless the Central Licensing authority revokes it.<\/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> Forms MD-14 and MD-15 are essential to acquire permit import of medical devices in India. CDSCO has streamlined this possible by making the stakeholders obtain this permission easily by applying through the Sugam portal. This license shall be valid to the applicant for perpetuity as long as he pays the retention 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\/registration-of-software-as-medical-device-in-india\/\">Registration of Software as Medical Device in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Central Drugs Standard Control Organisation (CDSCO) is the authority that works under the Directorate General of Health Services. CDSCO is responsible for permitting new medicines, creating rules\/ regulations, monitoring the effectiveness of the drugs and being in coordination with the state authorities in matters related to healthcare. Another essential function of CDSCO is that it [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11858,"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\/11848"}],"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=11848"}],"version-history":[{"count":15,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11848\/revisions"}],"predecessor-version":[{"id":11878,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11848\/revisions\/11878"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11858"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11848"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11848"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11848"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}