{"id":48251,"date":"2022-09-05T16:35:20","date_gmt":"2022-09-05T11:05:20","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48251"},"modified":"2022-09-05T16:35:22","modified_gmt":"2022-09-05T11:05:22","slug":"cdsco-medical-device-registration-for-glucometer","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-glucometer\/","title":{"rendered":"CDSCO Medical Device Registration for Glucometer"},"content":{"rendered":"\n<p>CDSCO is the National Regulatory Authority of India, which operates under the Ministry of Health and Family Welfare, under the Directorate General of Health Services, Government of India, and is responsible for regulating Medical devices, IVDs and Drugs in India. It is the Central Drug Authority of India, and is regulated by Drugs and Cosmetics Act. It is responsible for regulating the import, manufacture and approval of new drugs and medical devices and conducts clinical trials and meetings of DTAB or Drugs Technical Advisory Board and DCC or Drugs Consultative Community. <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> is the Central Licensing Authority and is responsible for approving licenses for various drugs and medical devices. It also regulates CDSCO Medical Device Registration for Glucometer.<\/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\/cdsco-medical-device-registration-for-glucometer\/#Glucometer_as_Medical_Device\" >Glucometer as 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\/cdsco-medical-device-registration-for-glucometer\/#Medical_Device_Regulation_in_India\" >Medical Device Regulation in India<\/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\/cdsco-medical-device-registration-for-glucometer\/#Risk_Based_Factors\" >Risk Based Factors<\/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\/cdsco-medical-device-registration-for-glucometer\/#Regulatory_Authorities_for_CDSCO_registration\" >Regulatory Authorities for CDSCO\nregistration<\/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\/cdsco-medical-device-registration-for-glucometer\/#Checklist_for_CDSCO_Medical_Device_Registration_for_Glucometer\" >Checklist for CDSCO\nMedical Device Registration for Glucometer<\/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\/cdsco-medical-device-registration-for-glucometer\/#Procedure_for_CDSCO_Medical_Device_Registration_for_Glucometer\" >Procedure for CDSCO Medical Device Registration for Glucometer<\/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\/cdsco-medical-device-registration-for-glucometer\/#Timeline_for_CDSCO_Medical_Device_Registration_for_Glucometer\" >Timeline for CDSCO Medical Device Registration for Glucometer<\/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\/cdsco-medical-device-registration-for-glucometer\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Glucometer_as_Medical_Device\"><\/span><strong>Glucometer as Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A <strong>glucometer<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Glucose_meter\"><strong>[1]<\/strong><\/a><\/sup> is a portable tool used to measure the amount of glucose in the blood. Today, the amount of blood needed for measurement is somewhere around 0.5 \u00b5l to 3.0 \u00b5l. Standard glucose metres and continuous glucose monitors are the two kinds of glucose metres (CGMs).<\/p>\n\n\n\n<p><strong>Glucometers are basically made up of three parts-<\/strong><\/p>\n\n\n\n<ol><li><strong>Glucometer:<\/strong>\nIt is the brain of the system and is usually smaller than a cell phone. In this\ndevice, electric impulses are turned into levels of blood sugar. When the blood\nmeets the enzyme on the test strip, electric impulses are made.<\/li><li><strong>Test\nstrip:<\/strong> It&nbsp;is a thin, flexible strip of plastic that is around 0.5\nto&nbsp;1 inch long. They are made to soak up a small drop of blood so that the\nmetre can read it. Between the top and bottom pieces of plastic are enzymes\nthat change when a drop of blood is put on them. You can only use these strips\nonce.<\/li><li><strong>Lancing\nDevice:<\/strong> Lancing Device is a glucometer lancet;&nbsp;it is a pen-shaped\ndevice with a spring-loaded mechanism. It is used to poke holes in\nthe&nbsp;skin to get blood.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Regulation_in_India\"><\/span><strong>Medical Device Regulation in India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Government of India&#8217;s Ministry of Health and Family\nWelfare stated in a notification that the following medical devices would be\nconsidered drugs as of January 1, 2021. The devices are as follows:<\/p>\n\n\n\n<p>1. Glucometer<\/p>\n\n\n\n<p>2. Nebuliser<\/p>\n\n\n\n<p>3. Blood Pressure monitoring\ndevice<\/p>\n\n\n\n<p>4. Electronic thermometer<\/p>\n\n\n\n<p>All of these devices must be registered in compliance with the quality parameters outlined in the Medical Devices Rules of 2017 and other standards set by the Bureau of Indian Standards (BIS).  The proposal to bring nebulisers, blood pressure monitors, digital thermometers, and glucometers under the preview of the Drug law was approved by the Drug Technical Advisory Body (DTAB), which is India&#8217;s highest drug advisory body. According to the notification, it is important to obtain CDSCO Medical Device Registration for Glucometer. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk_Based_Factors\"><\/span><strong>Risk Based Factors<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The vast majority of medical devices are\ncategorised according to the risks they have. The way in which a medical device\nis actually categorised according to the risks it poses is contingent on how\nand why it is used. The Different Classes of Medical Devices published by the\nCDSCO organises a more extensive assortment of medical tools, such as cannulas\nand stents, into subcategories with more granular designations.<\/p>\n\n\n\n<p><strong>Classification\nof Medical Devices Used in India:<\/strong><\/p>\n\n\n\n<p>There are several classification systems for\nin vitro diagnostic (IVD) and medical devices in India; each of these systems\nhas four classes that are organised according to the level of risk posed by the\nrespective devices. The following table lists four categories of medical\nequipment manufactured in India:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Medical\n  device class<\/strong>\n  <\/td><td>\n  <strong>Risk level <\/strong>\n  <\/td><\/tr><tr><td>\n  Class-A\n  <\/td><td>\n  Low-level risk\n  <\/td><\/tr><tr><td>\n  Class-B\n  <\/td><td>\n  Low-Moderate\n  level risk\n  <\/td><\/tr><tr><td>\n  Class-C\n  <\/td><td>\n  Moderate-High level\n  risk\n  <\/td><\/tr><tr><td>\n  Class-D\n  <\/td><td>\n  High-level risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>In\naccordance with the New Medical Rules that came into effect in 2017, the\nvarious Classes of Medical Devices have been separated into a total of four\ncategories. Any business that intends to manufacture such products for the\npurpose of distribution or sale is required to make an application to the CDSCO\nfor a manufacturer&#8217;s licence. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Authorities_for_CDSCO_registration\"><\/span><strong>Regulatory Authorities for CDSCO\nregistration<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Regulatory authorities\nfor registration CDSCO Medical Device Registration for Glucometer are-<\/p>\n\n\n\n<ul><li><strong>Central\nDrugs Standards Control Organization<\/strong>&#8211; It is the primary regulatory body in\nIndia that is responsible for regulating pharmaceuticals and medical devices.\nIt is part of the Directorate General of Health Services, which is part of the\nMinistry of Health and Family Welfare.<\/li><li><strong>Drug\nController General of India (DCGI) &#8211;<\/strong> This position serves as the head of\nCDSCO and is accountable for the regulation of clinical trials as well as the\napproval of high-quality drugs and cosmetics that are intended for sale in\nIndia.<\/li><li><strong>The Drugs\nand Cosmetic Act and Rules<\/strong>&#8211; In India, the Manufacture, Import, and\nDistribution of Drugs are all governed by a set of rules known as the Drugs and\nCosmetic Act and Rules.<strong><\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_for_CDSCO_Medical_Device_Registration_for_Glucometer\"><\/span><strong>Checklist for CDSCO\nMedical Device Registration for Glucometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the\nchecklist for CDSCO Medical Device Registration for Glucometer:<\/p>\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\n     provided <\/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_for_CDSCO_Medical_Device_Registration_for_Glucometer\"><\/span><strong>Procedure for CDSCO Medical Device Registration for Glucometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There were no\nrules\/regulations in place for the sale of medical devices in India&#8217;s market\nprior to 2006. Later, CDSCO made a rule that all medical devices on the market\nmust meet CDSCO&#8217;s standards. Because of the compliances, Medical Devices had to\nbe registered with CDSCO before they could be made, sold, or brought into the\nIndian market. Here are the steps you need to take to get CDSCO Medical Device\nRegistration for Glucometer.<\/p>\n\n\n\n<p><strong>1. Determine if Medical Devices\nare required to be registered-<\/strong> First, the applicant must look at the list of Medical\nDevices &amp; IVDs to see if the medical device has been notified. All medical\ndevices that are notified must be registered before they can be sold in India.\nIn this case, the glucometer is a &#8220;notified device&#8221; that needs to be\nregistered with CDSCO.<\/p>\n\n\n\n<p><strong>2. Risk-Based Classification\nof Medical Devices-<\/strong> Based on the risks associated with each of the notified\ndevices that must be registered with CDSCO, they are separated into different\ncategories. The Glucometer is in Class C of the risk-based classification of\nmedical devices because it has a medium level of risk.<\/p>\n\n\n\n<p><strong>3. Appointment of Indian\nAuthorized Agent-<\/strong> If the manufacturer is not an Indian, an IAA, or Indian\nAuthorized Agent, has been chosen. The IAA is the manufacturer&#8217;s legal\nrepresentative, and it does all of the manufacturer&#8217;s official work in India.<\/p>\n\n\n\n<p><strong>4. Documentation Process<\/strong>&#8211; To get a registration\nlicence, you have to give the right authorities all the documents they need.<\/p>\n\n\n\n<p><strong>5. Receiving Registration and\nLicense-<\/strong> The registration licence is given to the manufacturer after\nall the necessary paperwork has been sent to the right people.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_CDSCO_Medical_Device_Registration_for_Glucometer\"><\/span><strong>Timeline for CDSCO Medical Device Registration for Glucometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO\nMedical Device Registration for the Glucometer takes between six and nine\nmonths to finish after the application is turned in. The registration is still\nvalid for three years after it is made. If the registration needs to be\nrenewed, the renewal application must be submitted six months before the\nregistration expires.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Glucometer is a Class-C medical device; therefore, it is mandatory to register the device with CDSCO. Even the slightest mistake during the registration process could cause the application to be turned down. So, it&#8217;s always best to get help from a professional for CDSCO Medical Device registration for Glucometer.<\/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-device-registration-for-digital-thermometer\/\">CDSCO Medical Device Registration for Digital Thermometer<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO is the National Regulatory Authority of India, which operates under the Ministry of Health and Family Welfare, under the Directorate General of Health Services, Government of India, and is responsible for regulating Medical devices, IVDs and Drugs in India. It is the Central Drug Authority of India, and is regulated by Drugs and Cosmetics [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48252,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2695],"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":5178,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48251"}],"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=48251"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48251\/revisions"}],"predecessor-version":[{"id":48269,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48251\/revisions\/48269"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48252"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48251"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48251"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48251"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}