{"id":11826,"date":"2022-09-06T05:27:23","date_gmt":"2022-09-06T05:27:23","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11826"},"modified":"2022-09-06T05:31:58","modified_gmt":"2022-09-06T05:31:58","slug":"licensing-authorities-for-medical-device-product-registration-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/licensing-authorities-for-medical-device-product-registration-in-india\/","title":{"rendered":"Licensing Authorities for Medical Device Product Registration in India"},"content":{"rendered":"\n<p>The medical device industry in India is\ngrowing rapidly, and it is expected that it shall continue to do so in the\ncoming few years. As the Indian consumer is becoming more and more conscious about\nhis health, there has been a huge demand for medical device production both\ndomestically and internationally. The government had released the medical\ndevice rules in the year 2017 to regulate this market. These rules became\napplicable in 2018. The Central Drugs Standard Control Organisation (CDSCO)\nshall oversee these regulations. In this article, we shall learn about\nlicensing authorities for medical device product registration and its\nprocedure.<\/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-6a3a5bc17e1b8\" 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-6a3a5bc17e1b8\"  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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Government_Bodies_for_Medical_Device_Product_Registration_in_India\" title=\"Government Bodies for Medical Device Product Registration&nbsp;in\nIndia \n \n\">Government Bodies for Medical Device Product Registration&nbsp;in\nIndia \n \n<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Statutes_for_Medical_Device_Product_Registration_in_India\" title=\"Statutes for Medical Device Product Registration&nbsp;in\nIndia\">Statutes for Medical Device Product Registration&nbsp;in\nIndia<\/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\/licensing-authorities-for-medical-device-product-registration-in-india\/#Conclusion\" title=\"Conclusion:\">Conclusion:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Government_Bodies_for_Medical_Device_Product_Registration_in_India\"><\/span>Government Bodies for Medical Device Product Registration&nbsp;in\nIndia<br>\n<br>\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There are a few authorities that are\ninvolved in Medical device product registration in India; these are:<\/p>\n\n\n\n<ol><li><strong>Drug Controller General of India <\/strong><\/li><\/ol>\n\n\n\n<p>The Drugs and controller General of India overlooks the working of <strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\">CDSCO<\/a><\/strong>. It creates standards for the sales, manufacturing, import and distribution of drugs in India. It also acts as the appellate authority in case of any disputes surrounding drug quality in India. DGCI also looks after the national reference standard for drugs in the country. DGCI also makes sure that the medical device rules are implemented uniformly in all the states.<\/p>\n\n\n\n<ul><li><strong>Central Licensing Authority: <\/strong>This\nauthority shall function under the purview of the DGCI. This shall be the\ncompetent authority to enforce the rules that relate to importing all medical\ndevices in India. The central licensing authority shall also be responsible for\nthe manufacture of Class C&amp;D devices. They shall also conduct proper\ninspection, investigation and evaluation of in vitro medical devices and coordinate\nwith the State licensing authorities.<\/li><li><strong>State Licensing Authority: <\/strong>This body\nalso comes under the DGCI. It is also known as a state drugs controller. This\nauthority is responsible for enforcement of the rules for the sale, manufacture\nand distribution of Class A or Class B medical devices in the country. SLA\nshall also exhibit, stock or sell medical devices across the Classes.<\/li><\/ul>\n\n\n\n<ol><li><strong>CDSCO- Central Drugs Standard Control  Organisation (CDSCO): <\/strong><\/li><\/ol>\n\n\n\n<p>The CDSCO was created under the Directorate General of Health Services, Ministry of Health &amp; Family Welfare. The main department is in New Delhi, followed by six zonal, 4 Sub zonal and 13 port offices and seven labs in the country. The CDSCO ensures that medical products in the country conform to the safety norms and effectively carry out their functions. They also work to ensure that imported medical products also are of good quality and safe for Indian users. The CDSCO conducts clinical trials, lays down standards of conformity and sets rules for the manufacturers of drugs in the country. The CDSCO also constantly works and coordinates with the State agencies to uniformly enforce the Drugs and Cosmetics act.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Statutes_for_Medical_Device_Product_Registration_in_India\"><\/span>Statutes for Medical Device Product Registration&nbsp;in\nIndia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Two statutes govern Medical device\nregistration. Any stakeholder that is involved with Medical device registration\nmust comply with the rules in these regulations. These are:<\/p>\n\n\n\n<ul><li><strong>Drugs and Cosmetics Act, 1940<\/strong><\/li><\/ul>\n\n\n\n<p>The government\ncreated the Drugs and cosmetics act to control the manufacture, import and sale\nof medicines in India. The primary objective being that cosmetics and drugs\nsold in the country adhere to standards and are safe and effective. The act\ndeals with the import of drugs, thereby ensuring that no substandard medicines\nare dumped into the country. The act also facilitates the selling of drugs by\ntrained and competent individuals, including Ayurveda and homoeopathic drugs.\nThe act also specifies that timely samples must be collected, and they should\nbe studied in recognised laboratories. The act specifies eight medical items\nthat are regulated by it; these are; 1. Bone Marrow Cell Separator, 2. X-Ray\nmachine, 3. Dialysis machine, 4. PET Equipment, 5. Defibrillators, 6. MRI\nEquipment, 7. CT scan Equipment, 8. All implantable medical devices.<\/p>\n\n\n\n<ul><li><strong>Drugs and cosmetic Rules, 1945<\/strong><\/li><\/ul>\n\n\n\n<p>The Drugs and cosmetic rules of 1945 are a supplement to the <strong>drugs and cosmetics act of 1945<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>. The rules specify how the medicine should be classified, stored, displayed and distributed. The terms of licences for drugs are specified in Rule 67, and the Restriction on labelling is found in Rule 97. <\/p>\n\n\n\n<ul><li><strong>Medical device rules, 2017<\/strong><\/li><\/ul>\n\n\n\n<p>The medical\ndevices rules, 2017, have been created under Drugs cosmetic acts. The rules\nstate the requirements that need to be followed by manufacturers\/\nimporters\/marketers\/sellers of the notified medical device. The rules have made\nit mandatory for all the stakeholders involved with medical devices to obtain a\nlicense before undertaking any activity related to such devices. These licenses\nshall be granted after going through several quality checks. The rules have\nalso widened the ambit of the term &#8216;drugs&#8217; to encompass various medical devices\nunder it. Further, the act has also classified the medical device from Class\nA-D based on the risk that each category carries with itself. A total of 37\ncategories of medical devices have been laid down under these rules. They shall\nfall under the category of &#8216;newly notified medical devices.<\/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 Product Registration in India has become mandatory. A manufacturer\/importer or seller requires to deal with various licensing authorities. These include DGCI, CDSCO, state licensing authority, and central licensing authority. The procedure of obtaining the licenses should be as per the norms laid down under the Drugs and Cosmetics Act and rules, as well as the Medical device rules of 2017. <\/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>The medical device industry in India is growing rapidly, and it is expected that it shall continue to do so in the coming few years. As the Indian consumer is becoming more and more conscious about his health, there has been a huge demand for medical device production both domestically and internationally. The government had [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11827,"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\/11826"}],"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=11826"}],"version-history":[{"count":5,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11826\/revisions"}],"predecessor-version":[{"id":11833,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11826\/revisions\/11833"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11827"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11826"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11826"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11826"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}