{"id":46624,"date":"2022-08-12T13:24:11","date_gmt":"2022-08-12T07:54:11","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46624"},"modified":"2022-08-12T13:24:12","modified_gmt":"2022-08-12T07:54:12","slug":"what-is-form-md-14-and-md-15","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-is-form-md-14-and-md-15\/","title":{"rendered":"What is Form MD-14 and MD-15?"},"content":{"rendered":"\n<p>The Central Drugs Standard Control Organisation (CDSCO) operates under the Directorate General of Health Services, the Ministry of Health &amp; Family Welfare, under\u00a0the Indian government. It is the\u00a0National Regulatory Authority (NRA) of India. The <strong>Drugs and Cosmetics Act of 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup> now requires the registration of all medical devices as of April 1, 2020, in addition to the 23 previously notified medical devices. Starting October 1, 2022, all medical devices in Classes A and B will need Import Licenses before they can be brought into the country. By October 1, 2023, all Class C and D devices that have not already been notified will be required to obtain Import Licenses. Medical devices that don&#8217;t need Import Licenses yet should still register their product\u00a0through an e Portal, which can be done in a couple of days. The procedure of obtaining an Import license can be done by filling Form MD-14 and MD-15.<\/p>\n\n\n\n<p>Under the\nDrugs &amp; Cosmetics Act, the CDSCO is in charge of approving new drugs,\nrunning clinical trials, setting standards for drugs, keeping an eye on the\nquality of drugs that are brought into the country, and coordinating the\nactions of State Drug Control Organizations by giving them expert advice. The\ngoal is to make sure that the Drugs and Cosmetics Act is enforced in the same\nway everywhere.<\/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-14-and-md-15\/#Requirement_for_Registration_and_Import_License_for_Medical_Device\" >Requirement for Registration\nand Import License for Medical Device<\/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-14-and-md-15\/#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-3\" href=\"https:\/\/corpbiz.io\/learning\/what-is-form-md-14-and-md-15\/#Eligibility_Criteria_for_Import_License_for_Medical_Devices\" >Eligibility Criteria for Import\nLicense for Medical Devices<\/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-14-and-md-15\/#Procedure_for_Obtaining_Import_License_for_Medical_Devices\" >Procedure for Obtaining Import\nLicense for Medical Devices<\/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-14-and-md-15\/#Validity_of_Licence\" >Validity of Licence<\/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-14-and-md-15\/#Authorized_agent_or_Registration_holder_for_Medical_device\" >Authorized agent or\nRegistration holder for Medical device<\/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-14-and-md-15\/#Permission_to_Import_License_Form_MD-14_and_MD-15\" >Permission to Import\nLicense 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-8\" href=\"https:\/\/corpbiz.io\/learning\/what-is-form-md-14-and-md-15\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirement_for_Registration_and_Import_License_for_Medical_Device\"><\/span>Requirement for Registration\nand Import License for Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>All\nmedical devices must either be&nbsp;registered or require an Import License.\nDevice Master Files (DMF) for each product and Plant Master Files (PMF) for\neach manufacturing facility must be submitted in order to apply for an import\nlicence for the Notified device categories. Once they are accepted, medical\ndevices will be required to register under an Import License tied to the main\nplace where they are made By October 1, 2022, all Class A &amp; B medical\ndevices will require an Import License in order to stay on the market. The last\nClass C and D devices that haven&#8217;t been notified will be given time until\nOctober 1, 2023 to obtain an Import License. In the meantime, they will have to\nregister as a Non-Regulatory Product.<\/p>\n\n\n\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>The CDSCO (entral Drugs Standard Control Organization) has made a set of forms that people can use to apply for licences to use medical devices. These forms are different depending on what they will be used for. According to the risk associated with various medical devices, various forms have been categorised for importers and manufacturers. It&#8217;s easy to apply for a single <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device<\/strong><\/a>, but it takes a lot to apply for the import or production of multiple devices. There are 2 forms which need to be filled to get a license for Medical Devices- Form MD-14 and MD-15.<\/p>\n\n\n\n<p><strong>Form MD-14<\/strong>: Form\nMD-14 is filled to get the permission to import medical devices license based\non Class A, B, C or D. Fill out Form\nMD-14 to get a licence to import medical devices from Class A, B, C, or D.<\/p>\n\n\n\n<p><strong>Form MD-15<\/strong>: is a licence from CDSCO that lets people\nbring medical devices into India based on their A, B, C, or D classifications.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_Criteria_for_Import_License_for_Medical_Devices\"><\/span>Eligibility Criteria for Import\nLicense for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It is necessary to appoint an authorised\nIndian agent in order to obtain a licence using the Form MD-14 and MD-15. According\nto CDSCO rules, this agent must have a licence to manufacture&nbsp;or wholesale\nLicense Form 20B &amp; Form 21 B. The agent will submit a request using Form\nMD-14 and MD-15 to obtain a licence to import medical devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Obtaining_Import_License_for_Medical_Devices\"><\/span>Procedure for Obtaining Import\nLicense for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the Medical Device Rule of\n2017, the procedure for obtaining &#8220;Permission to Import Medical\nDevices&#8221; from CDSCO is as follows:<\/p>\n\n\n\n<ul><li>Product evaluation to determine whether it requires MDR 2017 registration (Regulated\/Non-Regulated).<\/li><\/ul>\n\n\n\n<ul><li>If registration is required, evaluate classification (Class A, B, C, and D) based on the product risk category.<\/li><\/ul>\n\n\n\n<ul><li>Make\u00a0documents according to the MD 14 checklist<\/li><\/ul>\n\n\n\n<ul><li>Choose an authorised agent<\/li><\/ul>\n\n\n\n<ul><li>Online creation of applications<\/li><\/ul>\n\n\n\n<ul><li>Approval\/confirmation of draft application by the authorised agent.<\/li><\/ul>\n\n\n\n<ul><li> Submission of application<\/li><\/ul>\n\n\n\n<ul><li>Follow up with the regulatory authority and query management; if any<\/li><\/ul>\n\n\n\n<ul><li>Medical device import approval in India is permitted<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_Licence\"><\/span>Validity of Licence<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Form\nMD-14 and MD-15 are used to get a licence to import medical devices. These\nforms are valid for life, or forever, as long as the licence retention fee is\npaid on a regular basis, as mentioned in the Second Schedule. The licence\nretention must be paid each time before the 5-year mark from the date the\nlicence was issued unless the Central Licensing Authority suspends or cancels\nthe licence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Authorized_agent_or_Registration_holder_for_Medical_device\"><\/span>Authorized agent or\nRegistration holder for Medical device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to sell medical devices in India,\na foreign manufacturer must first obtain the appropriate registration as\nrequired by Indian law. A foreign manufacturer is required by law to designate\nan authorised agent\/registration holder to handle the formalities on their\nbehalf for services involving medical devices and equipment.<\/p>\n\n\n\n<p>A company that lacks a local presence or\nregistered office in India is required to hire an authorised agent to act as an\nintermediary in order to manage registration. Also, the agent is needed for\npost-market surveillance of medical devices and equipment. The authorised agent\nacts as a go-between for the foreign manufacturer and the licencing authority,\npresenting any data, documents, facts, or information on behalf of the company.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Permission_to_Import_License_Form_MD-14_and_MD-15\"><\/span><strong>Permission to Import\nLicense Form MD-14 and MD-15<\/strong><strong><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Form\nMD-14 must be filled out in order to get an import licence. If the applicant is\na<strong> <\/strong>foreign&nbsp;business,\nthe application must be submitted by an authorised agent. Agents who apply on\nbehalf of foreign companies must have a valid wholesale licence for selling and\ndistributing drugs. The Central Licensing Authority gives the import licence in\nform MD-15. Hence both Form MD-14 and MD-15 are very important in getting an\nImport License<strong>.<\/strong><strong><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><strong><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p> In order to import medical devices into India, one must first obtain a licence from the Central Drugs Standard Control Organization (CDSCO). It is vital to fulfil all of the required conditions in order to obtain the License. This includes filling out Form MD-14 and MD-15, submitting fees and the required documents, etc., with the assistance of an authorising agent. In order to obtain the License, it is important to fulfil all of the required conditions. The process of obtaining a licence is necessary, and failure to do so may result in barriers in the way of the import\u202fof medical devices in\u202fIndia.\u00a0 <\/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-8-and-form-md-10\/\">What are Form MD-8 and Form MD-10?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drugs Standard Control Organisation (CDSCO) operates under the Directorate General of Health Services, the Ministry of Health &amp; Family Welfare, under\u00a0the Indian government. It is the\u00a0National Regulatory Authority (NRA) of India. The Drugs and Cosmetics Act of 1940[1] now requires the registration of all medical devices as of April 1, 2020, in addition [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46625,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2594],"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":8623,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46624"}],"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=46624"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46624\/revisions"}],"predecessor-version":[{"id":46638,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46624\/revisions\/46638"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46625"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46624"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46624"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46624"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}