{"id":48700,"date":"2022-09-14T14:12:24","date_gmt":"2022-09-14T08:42:24","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48700"},"modified":"2022-09-14T14:12:26","modified_gmt":"2022-09-14T08:42:26","slug":"how-to-get-medical-device-manufacturing-license-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/how-to-get-medical-device-manufacturing-license-in-india\/","title":{"rendered":"How to Get Medical Device Manufacturing License in India?"},"content":{"rendered":"\n<p>Central Drugs Standard Control Organization (CDCSO) is the highest Indian regulatory body that monitors the production of authorised medical devices. <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> is in charge of issuing licences and approving the manufacturing of medical devices. This problem of regulatory body Medical Device Manufacturing License by the <strong>Medical Device Rules of 2017<\/strong><sup><a href=\"https:\/\/www.dfda.goa.gov.in\/circulars-orders-notifications\/notification\/419-medical-device-rules-2017\"><strong>[1]<\/strong><\/a><\/sup>.<\/p>\n\n\n\n<p>While\nmanufacturing medical devices, a manufacturer must follow strict procedures\nfollowing the regulations and standards the Central Drug Standard Control\nOrganization (CDSCO) set forth. The New Medical Device Rules are enforced\nmainly and administered by the Central Government and the State Government.\nCDSCO works in coordination with the State Government to ensure uniform rule\nenforcement.<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Medical_Device_Regulation_in_India_%E2%80%93_An_Overview\" >Medical Device Regulation in\nIndia \u2013 An Overview<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Authorities_Regulating_CDSCO_Registration\" >Authorities Regulating CDSCO\nRegistration<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Medical_Device_Classification_Based_on_Risk_Levels\" >Medical Device Classification\nBased on Risk Levels<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Forms_required_to_obtain_Medical_Device_Manufacturing_License\" >Forms required to obtain\nMedical Device Manufacturing 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:\/\/corpbiz.io\/learning\/how-to-get-medical-device-manufacturing-license-in-india\/#Documents_required_to_obtain_Medical_Device_Manufacturing_License\" >Documents required to obtain\nMedical Device Manufacturing 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:\/\/corpbiz.io\/learning\/how-to-get-medical-device-manufacturing-license-in-india\/#Procedure_to_Obtain_Medical_Device_Manufacturing_License\" >Procedure to Obtain Medical\nDevice Manufacturing License<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Timeline_for_Medical_Device_Manufacturing_License\" >Timeline for Medical Device\nManufacturing License<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Regulation_in_India_%E2%80%93_An_Overview\"><\/span>Medical Device Regulation in\nIndia \u2013 An Overview<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If a\nmanufacturer wants to obtain Medical Device Manufacturing License for any class\nof medical device, there are a series of steps followed for the same. The\napplicant must apply for Manufacturing License to sell or distribute medical\ndevices. The applicants must use the online portal of the Ministry of Health\nand Family Welfare to apply for consent from the State Licensing Authority\nbased on their location. Forms MD-3 and MD-5 are used to obtain a licence for Class\nA and Class B medical devices. For the application, the manufacturer must\nsubmit an application in Form MD-3 and the necessary paperwork in Form MD-5.\nWhile Form MD-7 and MD-9 are used to obtain the licence to manufacture Class C\nand Class D medical devices, Form MD-7 is used to apply for permission to\nmanufacture Class C and Class D medical devices for sale and distribution, and\nForm MD-9 is the license for the same.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Authorities_Regulating_CDSCO_Registration\"><\/span>Authorities Regulating CDSCO\nRegistration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following\nbodies regulate all the rules related to medical devices in India:<\/p>\n\n\n\n<ul><li><strong>Central Drug Standard Control Organization-<\/strong><\/li><\/ul>\n\n\n\n<p>CDSCO is the\nhighest regulatory authority for drugs, IVDs and medical devices, governed by\nthe Directorate General of Health Services under the Ministry of Health &amp;\nFamily Welfare. It is also called CLA or the Central Licensing Authority of\nIndia. The CLA is responsible for providing a Medical Device Manufacturing\nLicense for class C and Class D medical devices with the high risk involved. It\nis responsible for regulating the import, sale and manufacturing of medical device\nClass C and Class D. It is also responsible for regulating rules and procedures\nfor IVDs. It also approves new medical devices and tests their clinical\nperformance and quality standards. It also grants registration of labs for\nperforming the tests and regular evaluation. It also gives licenses for\nmanufacturing or importing all classes of IVDs. <\/p>\n\n\n\n<ul><li><strong>Drug Controller General of India (DCGI)<\/strong><\/li><\/ul>\n\n\n\n<p>The head of\nCDSCO regulates clinical trials and approves the quality and standards of\ndrugs, medical devices and cosmetics for selling, importing or manufacturing in\nIndia. <\/p>\n\n\n\n<ul><li><strong>The Drugs and Cosmetic Act and Rules <\/strong><\/li><\/ul>\n\n\n\n<p>The procedure of\nmanufacture, import, and distribution are governed by the Drugs &amp; Cosmetic\nAct and Rules.<\/p>\n\n\n\n<ul><li><strong>State Licensing Authority<\/strong><\/li><\/ul>\n\n\n\n<p>The SLA or State\nLicensing Authority is the regulatory body responsible for providing Medical\nDevice Manufacturing License to medical devices with low to medium risk levels.\nIt gives licenses to Class A and Class B medical devices in India. The State\nLicensing Authority is authorised to grant licenses for manufacturing, loans\nand wholesale of Class A &amp; Class B Medical Devices. SLA authorises a\nNotified Body to inspect the Quality Management System and Technical Review for\nClass A &amp; B Medical Device manufacturers. It makes and regulates the rules\nand regulations for manufacturing, importing and selling of Medical Devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Classification_Based_on_Risk_Levels\"><\/span>Medical Device Classification\nBased on Risk Levels <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per the New\nMedical Rules of 2017, medical devices have been divided into four classes.\nClass-A, Class-B, Class-C and Class-D medical devices. Any manufacturer that\nintends to produce such devices for distribution or sale must apply for a\nmanufacturer&#8217;s licence from CDSCO. There are four classes of Indian medical\ndevices listed below-<\/p>\n\n\n\n<ul><li>Class A \u2013 the low risk involved<\/li><li>Class B \u2013 low to the moderate risk involved<\/li><li>Class C \u2013 moderate to high risk involved <\/li><li>Class D \u2013 the high risk involved<\/li><\/ul>\n\n\n\n<p>Medical devices\nclassified as Class A and B are considered low- and moderate-risk,\nrespectively. The applicant must apply to manufacture these classes of medical\ndevices to the State Licensing Authority. Classes C and D Devices are\ncategorised as High Risk and Extremely High Risk, respectively. The Central\nLicensing Authority must receive the application for their production. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_required_to_obtain_Medical_Device_Manufacturing_License\"><\/span>Forms required to obtain\nMedical Device Manufacturing License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nManufacturing License for the sale and distribution of Class A and Class B\nmedical devices is subject to regulation by the State Licensing Authority. To\nobtain a licence, the forms MD-3 and MD-5 are used; the applicant must submit\nan application in Form MD-3 along with the necessary paperwork, and the license\nis obtained in Form MD-5.<\/p>\n\n\n\n<p>To get a\nManufacturing License for class C and Class D medical devices, The manufacturer\nmust submit an online application using Form MD-7 through the Central Licensing\nAuthority of the Ministry of Health &amp; Family Welfare in the Central\nGovernment to be granted a Medical Device Manufacturing License for the continued\nsale &amp; distribution of Class C and Class D medical devices through Form\nMD-9.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_obtain_Medical_Device_Manufacturing_License\"><\/span>Documents required to obtain\nMedical Device Manufacturing License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Application Form <\/li><li>ISO 13485 Certificate <\/li><li>TR6 Challan<\/li><li>Power of attorney<\/li><li>Undertaking that only authentic details are\nprovided <\/li><li>Full quality assurance certificate <\/li><li>CE Design certificate <\/li><li>Declaration of conformity<\/li><li>Schedule D(I) <\/li><li>Device master file <\/li><li>Plant master report <\/li><li>Free Sale Certificate&nbsp; <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_Medical_Device_Manufacturing_License\"><\/span>Procedure to Obtain Medical\nDevice Manufacturing License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before 2006,\nthere were no laws or regulations governing the sale or use of medical devices\nin India. Later, CDSCO issued a rule requiring all medical devices sold on the\nmarket to comply with CDSCO. Medical Devices must be registered with CDSCO\nbefore being manufactured, sold, or imported into the Indian market due to\ncompliance requirements. The steps to obtain Medical Device Manufacturing\nLicense in India are listed below. \u2013<\/p>\n\n\n\n<ul><li><strong>Check whether a Medical Device Manufacturing license is required or not-\u00a0 <\/strong>\u00a0<\/li><\/ul>\n\n\n\n<p>The person applying for the license must first check if the medical device has been notified. All medical devices that have been reported are required to be registered before being marketed in India. <\/p>\n\n\n\n<ul><li><strong>Classification of Medical Devices based on risk-<\/strong><\/li><\/ul>\n\n\n\n<p>As per the risks\nassociated with each device, the notified ones that must be registered with\nCDSCO are then determined.<\/p>\n\n\n\n<ul><li><strong> Appointment of Indian Authorized Agent-<\/strong> <\/li><\/ul>\n\n\n\n<p>If the manufacturer is not an Indian, an IAA\/Indian Authorized Agent, has been named. The IAA, the manufacturer&#8217;s official representative in court, carries out all of its business in India.<\/p>\n\n\n\n<ul><li><strong>Documentation Procedure-<\/strong><\/li><\/ul>\n\n\n\n<p>To obtain a\nMedical Device Manufacturing License, all required paperwork must be submitted\nto the appropriate authorities.<\/p>\n\n\n\n<ul><li><strong>Receiving Registration and License- <\/strong><\/li><\/ul>\n\n\n\n<p>&nbsp;After submitting all required documents to the\nappropriate authorities, the manufacturer receives the Medical Device\nManufacturing License.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_Medical_Device_Manufacturing_License\"><\/span>Timeline for Medical Device\nManufacturing License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The validity of\nthe Manufacturing License is five years. In the case of the request being\nsuspended or cancelled, the applicant shall apply within 45 days from the date\nof the action.<\/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 Indian medical regulation and rules have become more complex over time. There was no such authority to regulate Drugs, Medical Devices and other medicine-related products in India. Still, now the CDSCO performs all the tasks to regulate and control such activities. There are multiple categories of devices that require registration in India. Medical Device Registration is a complex process and requires only regulated devices to apply for registration. For all the devices that do not require any registration, a NOC has to be obtained from the DCGI to sell or market those products. The NOC letter signed by the DCGI signifies that there is no requirement for product registration, and it can easily be marketed in India just by carrying the NOC. <\/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\/cdsco-medical-devices-manufacturing-registration-requirement\/\">CDSCO Medical Devices Manufacturing Registration Requirement<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Central Drugs Standard Control Organization (CDCSO) is the highest Indian regulatory body that monitors the production of authorised medical devices. CDSCO is in charge of issuing licences and approving the manufacturing of medical devices. This problem of regulatory body Medical Device Manufacturing License by the Medical Device Rules of 2017[1]. While manufacturing medical devices, a [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48701,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2715],"acf":{"service_id":"508"},"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":10985,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48700"}],"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=48700"}],"version-history":[{"count":17,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48700\/revisions"}],"predecessor-version":[{"id":48719,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48700\/revisions\/48719"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48701"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}