{"id":49400,"date":"2022-09-27T18:35:11","date_gmt":"2022-09-27T13:05:11","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49400"},"modified":"2022-09-27T18:35:12","modified_gmt":"2022-09-27T13:05:12","slug":"licensing-authorities-for-medical-device-product-registration-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/licensing-authorities-for-medical-device-product-registration-in-india\/","title":{"rendered":"Licensing Authorities for Medical Device Product Registration in India"},"content":{"rendered":"\n<p>In older times, manufacturing devices were sold without any law guiding them in India. In the year 2016, a rule was set forth which stated that the medical devices in India must be in accordance with the Medical Device Regulations, which are governed by Central Drug Standard Control Organization <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>. The CDSCO is the main body responsible for making rules, regulations and standards for Drugs, Medicinal devices, IVDs etc. It lays down standards and rules for the regulation of medical devices in India and controls the Import, Export, Manufacturing and Sales of Medical devices and drugs in India. It advises and coordinates with the State Drug Control Organization (SDCO) and maintains the laws and rules of the <strong>Drugs and Cosmetics Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup>. In this blog, we will discuss Licensing Authorities for Medical Device Product Registration in India.<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Authorities_controlling_Medical_Device_Product_Registration_in_India\" >Authorities\ncontrolling Medical Device Product Registration in India<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Central_Drug_Standards_Control_Organization_CDSCO\" >Central\nDrug Standards Control Organization (CDSCO)<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#The_Drug_Controller_General_of_India_DCGI\" >The\nDrug Controller General of India (DCGI)<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Drugs_and_Cosmetics_Acts_and_Rules\" >Drugs\nand Cosmetics Acts and Rules<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Different_types_of_Medical_Devices\" >Different\ntypes of Medical Devices-<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Procedure_for_Medical_Device_Product_Registration\" >Procedure\nfor Medical Device Product Registration<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Authorities_controlling_Medical_Device_Product_Registration_in_India\"><\/span>Authorities\ncontrolling Medical Device Product Registration in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>All the drugs and medical devices being circulated in\nIndia are duly regulated and controlled by the Indian government to ensure the\nsafety and good health of the people using those devices or drugs. For this\nreason, the Indian government has formed various bodies in order to keep a\ncheck and control the Import, Export, Manufacturing and Sales of Medical\ndevices, Drugs and Medicine related products in India. Those governing bodies\nare as follows- <\/p>\n\n\n\n<ul><li>Central Drug\nStandards Control Organization (CDSCO)<\/li><li>The Drug\nController General of India (DCGI)<\/li><li>Drugs and\nCosmetics Acts (1940) and Rules (1945) <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Central_Drug_Standards_Control_Organization_CDSCO\"><\/span>Central\nDrug Standards Control Organization (CDSCO)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drug Standards Control Organization\n(CDSCO) works under the Directorate General of health services, the Ministry of\nHealth and Family Welfare, and the Government of India. CDSCO is the NRAI or\nNational Regulatory Authority of India. The CDSCO headquarter is located in New\nDelhi, and it has multiple zonal offices all over India. CDSCO also works along\nwith Central Drug Laboratories in order to perform tests. CDSCO also works with\nDrugs Technical Advisory Board and the Drug Consultative Committee. Other than\nMedical Device Product Registration, CDSCO is also responsible for granting\nlicenses to certain drugs and medical devices. The central authorities are\naccountable for approving new drugs, conducting trials to lay down standards\nfor the quality of Drugs to be imported, and various other activities. The\nstate authorities as well are responsible for regulating the rules related to\nthe manufacture, sale and distribution of drugs and medical devices, etc. These\nbodies are formulated under the Drugs and Cosmetics Acts, 1940 and Rules, 1945.\n<\/p>\n\n\n\n<p><strong><em>There are various functions that CDSCO performs. The\nfunctions are- <\/em><\/strong><\/p>\n\n\n\n<ul><li>Medical Device Product\nRegistration<\/li><li>Setting up\nstandards for Medical devices, Drugs, IVDs etc. <\/li><li>Setting up laws,\nregulations, amendments and rules for Drugs, Medicines, Medical Devices, IVDs,\netc. <\/li><li>Regulating the\nmarket authorization of Drugs and Medical Devices.<\/li><li>Regulating the\nClinical Research and Drug trials in India. <\/li><li>Approval of\nlicense to manufacture certain Drugs and other medicine-related devices <\/li><li>Regulating the\nstandard of imported drugs in India. <\/li><li>Testing of Drugs\nthrough Central Drugs labs. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Drug_Controller_General_of_India_DCGI\"><\/span>The\nDrug Controller General of India (DCGI)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drug Controller General of India (DCGI) is the\nHead of the Department of the Central Drugs Standard Control Organization\n(CDSCO) in India. DCGI can approve the license for certain categories in India,\nsuch as Blood and Blood components, vaccines, etc. The DCGI functions under the\nMinistry of Health &amp; Family Welfare and establishes the regulations and\nstandards for the sale, manufacture, import-export and distribution of Drugs in\nIndia. There are various other functions performed by DCGI-<\/p>\n\n\n\n<ul><li>The DCGI is\nresponsible for providing approval for Medical Device Product Registration.<\/li><li>The DCGI sets up\nrules and standards for sales, manufacture, Import, export and regulation of\nDrugs, Medical devices, medicine-related drugs, IVDs, etc.<\/li><li>DCGI is the\nappellate authority for any case or dispute related to the quality or standard\nof drugs or any medical device.<\/li><li>DCGI is\nresponsible for preparing and maintaining national reference standards for\ndrugs in India. <\/li><li>The DCGI ensures\nthat the laws and regulations for Drugs and Medical Devices are as per the\nDrugs and Cosmetics Acts, 1940.<\/li><li>DCGI is in charge\nof the training of Drug Analysts, which is deputed by State Drug Control\nLaboratories and other bodies. <\/li><li>DCGI is in charge\nof analyzing the cosmetics which are received from CDSCO as survey samples.<\/li><li>The DCGI is the\nCentral Licensing Authority for Medical Devices, which comes under the Medical\nDevice Rules, 2017. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Drugs_and_Cosmetics_Acts_and_Rules\"><\/span>Drugs\nand Cosmetics Acts and Rules<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drugs &amp; Cosmetics Acts, 1940 and Drugs and\ncosmetics rules 1945 have allotted many responsibilities to the Central and\nState regulatory authority for the regulation of drugs and cosmetics in India.\nIt ensures safety, standardization, quality, durability, efficiency and\nreliability of medical devices, Drugs and other medical-related products\ndistributed all over India, with the aim of bringing out transparency,\neffectiveness and quality service and making sure that the consumers are\nreceiving safe, efficient and quality products, which are certified by CDSCO. <\/p>\n\n\n\n<p>The Drugs and Cosmetics Acts and Rules are a set of\nlaws that regulate the approval of new drugs, set down the quality standards and\nmaintain the quality of drugs and Medical Devices and various other activities\nrun by the State Drug Control Organization.&nbsp;\n<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_types_of_Medical_Devices\"><\/span>Different\ntypes of Medical Devices- <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On the basis of Risks, the medical devices can be\ndivided into the following categories-<\/p>\n\n\n\n<ul><li>Class A- Low-risk\ndevices. For Example- Thermometers, tongue depressors, etc. <\/li><li>Class B- Low to\nMedium risk devices. For example- include hypodermic needles, suction\nequipment, etc. <\/li><li>Class C- Medium\nto high-risk devices. For example- lung ventilators, bone fixators, etc. <\/li><li>Class D-\nHigh-risk devices. For example- heart valves, implantable devices, etc. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_Medical_Device_Product_Registration\"><\/span>Procedure\nfor Medical Device Product Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to CDSCO, all the Notified medical devices\nare required to be registered by CSDSO in order to sell, manufacture, Import,\nexport, etc. All the non- notified and Non- regulated products which have\nobtained a NOC are not required to be registered by CDSCO. Following is the\nprocedure to conduct all the regulated Medical Device Product Registration-<\/p>\n\n\n\n<ul><li>A local Indian\nagent is appointed in order to apply for the registration and license. <\/li><li>Device Master\nFile or DMF is prepared <\/li><li>Plant Master File\nor PMF is prepared <\/li><li>An application\nform is prepared for the process of registration, along with the required\ndocuments along with the required fees. <\/li><li>The documents are\nthen submitted to the DCGI.<\/li><li>DCGI reviews the\ndocuments and reverts them with an Inquiry letter if in case of any Inquiry. <\/li><li>The inquiry made\nby DCGI (if any) has to be answered by the applicant<\/li><li>The license is\nthen approved by the DCGI if he is satisfied with the process of inquiry<\/li><li>Medical Device\nProduct Registration is then granted to the applicant. <\/li><\/ul>\n\n\n\n<p>The Medical Device Product Registration process may\ntake around 9-18 months if there are no clinical trials. There are a few\nessential points to be noted while applying for Medical Device Product\nRegistration. These are- <\/p>\n\n\n\n<ul><li>The manufacturers\nmust register the medical devices in the DCGI office first before entering the\nmarket. <\/li><li>DCGI&#8217;s prior\napproval is mandatory to be obtained before the New Medical devices are applied\nfor registration.<\/li><li>The application\nform, with the required fees, is submitted, which is followed by the\nassessments or clinical tests. <\/li><li>The clinical\ntesting can be done either in India or outside India.<\/li><li>The manufacturing\npremises can be visited by the DCGI anytime during the process. <\/li><\/ul>\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 &amp; rules have become more complex over time. There was no such authority to regulate &amp; control Drugs, Medical Devices &amp; other medicine-related products in India, but now the CDSCO performs all the tasks to regulate and control such activities. There are various categories of devices that need registration in India. Medical Device Product Registration is a very complex process &amp; requires only regulated devices to apply for registration. For all the devices that don&#8217;t require any registration, a NOC has to be obtained from the DCGI in order to sell\/market those products. The NOC (No Objection Certificate) letter signed by the DCGI signifies that there is no requirement for the registration of the product, &amp; 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\/voluntary-registration-of-medical-device\/\">Voluntary Registration of Medical Device \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In older times, manufacturing devices were sold without any law guiding them in India. In the year 2016, a rule was set forth which stated that the medical devices in India must be in accordance with the Medical Device Regulations, which are governed by Central Drug Standard Control Organization CDSCO. The CDSCO is the main [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":49401,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2746],"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":3133,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49400"}],"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=49400"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49400\/revisions"}],"predecessor-version":[{"id":49411,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49400\/revisions\/49411"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49401"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49400"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49400"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}