{"id":15706,"date":"2020-09-02T15:02:00","date_gmt":"2020-09-02T09:32:00","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=15706"},"modified":"2020-09-02T15:09:20","modified_gmt":"2020-09-02T09:39:20","slug":"registration-process-for-medical-devices-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/","title":{"rendered":"A Step by Step guide for Registration Process for Medical Devices in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Previously, the medical devices manufacturers were free to sell their products in the Indian market without any regulation. Since 2006, the medical devices imported from overseas locations need to comply with Indian medical device regulations established by CDSCO. The CDSCO (Central Drugs Standard Control Organisation) is a statutory body that laid down rules for new drug and clinical trials. In this blog, we will focus on the Registration process for medical devices 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\/registration-process-for-medical-devices-in-india\/#Classes_of_Medical_Devices\" >Classes of Medical Devices<\/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\/registration-process-for-medical-devices-in-india\/#Guidelines_for_Registration_Process_for_Medical_Devices\" >Guidelines for Registration Process for Medical Devices<\/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\/registration-process-for-medical-devices-in-india\/#Duties_Serve_by_the_Authorized_Agents\" >Duties Serve by the Authorized Agents<\/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\/registration-process-for-medical-devices-in-india\/#Minimum_Eligibility_Criteria_for_Authorized_Agents\" >Minimum Eligibility Criteria for Authorized Agents<\/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\/registration-process-for-medical-devices-in-india\/#Valuable_Pointers_regarding_the_Registration_Process_for_Medical_Devices\" >Valuable Pointers regarding the Registration Process for 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\/registration-process-for-medical-devices-in-india\/#Conclusions\" >Conclusions<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classes_of_Medical_Devices\"><\/span>Classes of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>The medical devices in India have been categorized into four classes based on the criticality and risk they offer to the patients. <\/em><\/strong><\/p>\n\n\n\n<ul><li><strong>Class A:<\/strong> Represent the low-risk category of the products such as thermometers, and tongue depressors. <\/li><li><strong>Class B<em>:<\/em><\/strong> Represent moderate-risk products such as suction equipment and hypodermic needles. <\/li><li><strong>Class C:<\/strong> Represent moderate-high risk products such as bone fixation and lung ventilator.<\/li><li><strong>Class D<em>:<\/em><\/strong> Represent high-risk products such as implantable devices and heart valve.<\/li><\/ul>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/benefits-of-drug-license-that-you-must-know\/\">Four Prominent Benefits of Drug license that you must know<\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Guidelines_for_Registration_Process_for_Medical_Devices\"><\/span>Guidelines for Registration Process for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"624\" height=\"343\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-4.png\" alt=\"Registration Process for Medical Devices\" class=\"wp-image-15707\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-4.png 624w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-4-300x165.png 300w\" sizes=\"(max-width: 624px) 100vw, 624px\" \/><\/figure><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Check if Product Seek Registration<\/h3>\n\n\n\n<p>In India, the manufacturing and distribution of medical devices are regulated by the <strong><em>Drug and Cosmetics Act, 1947<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong><em>[1]<\/em><\/strong><\/a><\/sup>. Presently, the act covers the 22 notified medical devices. The following section demonstrates the list of devices comes under the said act.<\/p>\n\n\n\n<ul><li>Cochlear implant <\/li><li>Spinal needles<\/li><li>Tracheostomy tubes<\/li><li>Cardiac stent<\/li><li>Syringes<\/li><li>Endotracheal tube<\/li><li>Dental implant<\/li><li>Annuloplasty ring<\/li><li>Catheters<\/li><li>Surgical sealants<\/li><\/ul>\n\n\n\n<p>The list is not over yet, as many\nmore devices come under the influence of said act. In some circumstances, DCGI\nscrutinizes specific product details and could confer NOC regarding the medical\ndevices&#8217; exemption. The whole process takes one to three months to reach\ncompletion. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Hire Authorized Indian Agent <\/h3>\n\n\n\n<p>The registration cannot be\ngranted to someone who not from the Indian territory. The said act allows the\noverseas manufacturers to hire an authorized Indian agent to address the\nregistration formalities. The manufacturer needs to ensure that the hired\nprofessional should be registered under CDSCO. Plus, he\/she should possess a\nwhole drug license as well in the form of 20B and 21B. Once availed, the\nregistration certificate will allow the manufacturer to appoint multiple\ndistributors in India. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Submission of the Dossier under Form 40<\/h3>\n\n\n\n<p>This is the first and foremost\nstep in the registration process. Here, the hired agent needs to prepare and\nsubmit a dossier against the requested list of documents. The following list\ndemonstrates the type of documents required for registration purposes. <\/p>\n\n\n\n<ul><li>Form 40<\/li><li>TR6 Challan<\/li><li>Schedule D(I)<\/li><li>Power of attorney<\/li><li>Quality assurance certificate<\/li><li>Conformity declaration<\/li><li>PMS* report<\/li><li>Master file of the device<\/li><li>Master file of the plant <\/li><li>Sale certificate <\/li><li>Regulatory approvals<\/li><li><a href=\"https:\/\/corpbiz.io\/ce-certification\"><strong>CE certificate<\/strong><\/a> <\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">What does PMS stands for?<\/h4>\n\n\n\n<p>PMS &#8211; PMS stands for post-market\nsurveillance. It is an accumulation of the compliant data received over the\nperiod of time. It helps the manufacturer depict trends in the complaint data\nto overcome the area of vulnerabilities within the equipment to ensure better\nfunctioning. <\/p>\n\n\n\n<p>The registration fees charged by\nthe CDSCO for a single manufacturing unit is US$1500. Furthermore, if the\napplicant seeks registration for a particular set of devices, then the\nregistration fees would be US$ 1000. The authority might take anywhere between\nsix to nine months to complete the process. The processing may be extended if\nthe product doesn&#8217;t have a base in the Indian territory. In such cases, the\nauthority appoints a special committee that scrutinizes the products on different\ngrounds and their potency for the Indian market. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Avail Registration Certificate in Form 41<\/h3>\n\n\n\n<p>After investigating the\nsubmitted documents, CDSCO will respond to the authorized agents with a query\nletter. The agent needs to answer the queries and deliver them back to the\nauthority within the requested timeframe. Upon receiving the answers, the\nauthority shall test the applicant&#8217;s response and eventually decide to grant\nthe license. In case if the authority is not satisfied by the response, it may\nforward another query letter to the applicant. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Avail Import License in Form 10<\/h3>\n\n\n\n<p>In order to avail of import\nlicense in form 10, an application has to be filed in Form 8 and 9 at the CDSCO\nSUGUM portal. The authority usually process such a request in 4 to 12 weeks. <\/p>\n\n\n\n<p>Once the applicant avail the <a href=\"https:\/\/corpbiz.io\/iec-registration\"><strong>import license<\/strong><\/a> and registration certificate, the shipment of medical devices can enter the Indian territory. Furthermore, the manufacturers can sign a contract with distributors for selling their products across the Indian market. The registration would serve the validity period of three months.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Duties_Serve_by_the_Authorized_Agents\"><\/span>Duties Serve by the Authorized Agents<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Provide constant\nfeedback to the manufacturer regarding the policy changes or obnoxious events<\/li><li>Connect with the\nauthority to apply for a medical device certificate. <\/li><li>Arrange mandatory\nfrom the manufacturer for the registration purpose.<\/li><li>Coordinate with\nmanufacturers to share post-market surveillance data and adversaries. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Minimum_Eligibility_Criteria_for_Authorized_Agents\"><\/span>Minimum Eligibility Criteria for Authorized Agents<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Candidates should belong to the Indian territory and have few years of experience in the health care industry. <\/li><li>Candidates should possess &#8220;Power of attorney&#8221; to submit documents related to medical device certificate at CDSCO. <\/li><li>Candidate should have a <a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\"><strong>drug wholesale license<\/strong><\/a> under the possession in the form of 20-B and 21-B. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Valuable_Pointers_regarding_the_Registration_Process_for_Medical_Devices\"><\/span>Valuable Pointers regarding the Registration Process for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>CDSCO is the\nprominent regulatory body in India that lays the guidelines for medical devices\nand pharmaceuticals to ensure the patients&#8217; safety and well-being. Central Drug\nStandards Control Organization (CDSCO) continually trying to impart\ntransparency and uniformity in its system to ensure the quality of the medical\nproducts. CDSCO has synced various state regulators for granting the license\nfor specific drugs, vaccines, and IV fluid. <\/li><li>The Drug Controller\nGeneral of India (DCGI) is one of the key representatives within CDSCO who is\nresponsible for sanctioning the new drugs and medical devices in India.<\/li><li>Drugs &amp; Cosmetic\nAct and Rules (DCA) is a statutory framework that outlines the directives for\nthe drug and medical equipment in India.&nbsp;\n<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusions\"><\/span>Conclusions <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>registration of medical devices<\/strong><\/a> is crucial in India for distribution purposes. The concerned authority would penalize any manufacturer who wish to sell the product in unregistered condition. Connect with <a href=\"https:\/\/corpbiz.io\/\"><strong>CorpBiz&#8217;s<\/strong><\/a> professional to avail professional help on <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug licenses<\/strong><\/a> and other registration in India. <\/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\/importance-of-a-medical-device-certificate-in-india\/\">What is the Importance of a Medical Device Certificate in India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Previously, the medical devices manufacturers were free to sell their products in the Indian market without any regulation. Since 2006, the medical devices imported from overseas locations need to comply with Indian medical device regulations established by CDSCO. The CDSCO (Central Drugs Standard Control Organisation) is a statutory body that laid down rules for new [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":15741,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[950],"acf":{"service_id":"385"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":9529,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15706"}],"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\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=15706"}],"version-history":[{"count":7,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15706\/revisions"}],"predecessor-version":[{"id":51088,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15706\/revisions\/51088"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/15741"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=15706"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=15706"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=15706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}