{"id":48239,"date":"2022-09-05T16:12:19","date_gmt":"2022-09-05T10:42:19","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48239"},"modified":"2022-09-05T16:13:20","modified_gmt":"2022-09-05T10:43:20","slug":"cdsco-medical-device-registration-for-digital-thermometer","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-digital-thermometer\/","title":{"rendered":"CDSCO Medical Device Registration for Digital Thermometer \u2013 An Overview"},"content":{"rendered":"\n<p>Central Drug Standard Control Organization, or CDSCO, is the National Regulatory Authority of India and is responsible for the regulation of Medical Devices, IVDs and Drugs in India. It works under the Ministry of Health and Family Welfare, which is regulated by the Directorate General of Health Services under the Indian Government. CDSCO is also governed by the Drugs and Cosmetics act and is known as the Central Drug Authority of India. It keeps a check on the import, manufacturing and marketing of new drugs, medical devices, IVDs and Drug related products in India and has the authority to provide licenses, because of which it is also called the Central Licensing Authority. It provides licenses for the registration, import and manufacture of medical devices and IVDs. The CDSCO <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Device Registration<\/strong><\/a> for Digital Thermometers is also governed by it. CDSCO also conducts clinical trials of drugs and conducts meetings of the Drugs Consultative Community and Drugs Technical Advisory Board.<\/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-digital-thermometer\/#Digital_Thermometer_as_Medical_Device\" >Digital Thermometer 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-digital-thermometer\/#Applications_for_Digital_Thermometers\" >Applications for Digital Thermometers<\/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-digital-thermometer\/#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-digital-thermometer\/#Regulatory_Authorities_for_CDSCO_Registration\" >Regulatory Authorities for CDSCO Registration<\/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-digital-thermometer\/#Checklist_for_CDSCO_Medical_Device_Registration_for_Digital_Thermometer\" >Checklist for CDSCO Medical Device Registration for Digital Thermometer<\/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-digital-thermometer\/#Procedure_for_CDSCO_Medical_Device_Registration_for_Digital_thermometer\" >Procedure for CDSCO Medical Device Registration for Digital thermometer<\/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-digital-thermometer\/#Timeline_for_CDSCO_Medical_Device_Registration_for_Digital_Thermometer\" >Timeline for CDSCO Medical Device Registration for Digital Thermometer<\/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-digital-thermometer\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Digital_Thermometer_as_Medical_Device\"><\/span><strong>Digital Thermometer as Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Digital\nthermometers are instruments that are used to sense temperature and are easily\nportable, and have permanent probes, along with a convenient digital display.\nThe way a digital thermometer work is dependent upon its type of sensor. <\/p>\n\n\n\n<p><strong>Sensors of digital thermometer include-<\/strong><\/p>\n\n\n\n<ul><li>Resistance Temperature Detector (RTD)<\/li><li>Thermocouple <\/li><li>Thermistor<\/li><\/ul>\n\n\n\n<p><strong>Important specifications for digital thermometers include- <\/strong><\/p>\n\n\n\n<ul><li>Display Options<\/li><li>User interface <\/li><li>Outputs <\/li><li>Operating environment<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Applications_for_Digital_Thermometers\"><\/span><strong>Applications for Digital Thermometers<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are\nthe applications for Digital Thermometers:<\/p>\n\n\n\n<ul><li><strong>Medicinal\nuses-<\/strong> Digital thermometers are often used in clinical settings on patients.<\/li><li><strong>HVAC\nthermometers<\/strong>&#8211; HVAC thermometers are used for applications such as duct or\nflume monitoring.<\/li><li><strong>Sanitary\nuses-<\/strong> Thermometers are used for sanitary purposes such as food or\npharmaceutical applications.<\/li><li><strong>Home use-<\/strong>\nHome uses include digital thermometers used for home health care, cooking &amp;\nmonitoring temperature on home appliances such as the refrigerator\/swimming\npool.<\/li><li><strong>Laboratory\nuses-<\/strong> Laboratory uses includes monitoring experiments and chemical\nreactions as well as maintaining an optimal laboratory environment.<\/li><li><strong>Food\nService-<\/strong> Thermometers in identifying completeness of cooking and sanitation\nof ingredients.<\/li><li><strong>Meteorological\nthermometers-<\/strong> Thermometers are also used to give air, atmosphere and water\ntemperature readings.<\/li><\/ul>\n\n\n\n<p><strong>Medical Device Regulation in India<\/strong><\/p>\n\n\n\n<p>As of January 1,\n2021, the following devices must be regarded as drugs, according to a\nnotification from the Government of India&#8217;s Ministry of Health and Family\nWelfare. The devices are as follows-<\/p>\n\n\n\n<ul><li>Digital thermometer<\/li><li>Glucometer<\/li><li>Nebuliser<\/li><li>Blood pressure monitor<\/li><\/ul>\n\n\n\n<p>All of these devices will need to be registered in accordance with the quality requirements outlined in the <strong>Medical Devices 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> and other standards established by the Bureau of Indian Standards (BIS) accreditation.<\/p>\n\n\n\n<p>The proposal to\nbring nebulisers, blood pressure monitors, digital thermometers, and\nglucometers under the purview of the Drug law was approved by the Drug\nTechnical Advisory Body (DTAB), the highest drug advisory body in India.<\/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>Most medical\ndevices are categorised according to the risks involved. Depending on how and\nwhy it is used, a medical device may actually be categorised according to its\nrisks. A larger group of medical devices, such as cannulas and stents, are\ndivided into smaller groups with more precise names according to CDSCO&#8217;s\nDifferent Classes of Medical Devices.<\/p>\n\n\n\n<p>In India, there\nare four medical device classification systems, and each of these systems has\nfour classes according to their risk classification. There are four different\ntypes of Indian medical devices listed in the table below-<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Medical device Class<\/strong>\n  <\/td><td>\n  <strong>Risk Associated <\/strong>\n  <\/td><\/tr><tr><td>\n  Class A\n  medical device\n  <\/td><td>\n  Low Risk\n  <\/td><\/tr><tr><td>\n  Class B\n  medical device\n  <\/td><td>\n  Low Moderate\n  Risk\n  <\/td><\/tr><tr><td>\n  Class C\n  medical device\n  <\/td><td>\n  Moderate-High Risk\n  <\/td><\/tr><tr><td>\n  Class D\n  medical device\n  <\/td><td>\n  High Risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>According to the\nNew Medical Rules of 2017, various classes of medical devices have been divided\ninto four distinct categories. A, B, C, and D Classes. Any business that\nintends to produce such devices for distribution or sale must apply for a\nmanufacturer&#8217;s licence from CDSCO.<\/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 Registration<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following\nare the regulatory bodies for CDSCO Medical Device Registration for Digital\nThermometer:<\/p>\n\n\n\n<ul><li><strong>Central\nDrug Standard Control Organization (CDSCO):<\/strong> It is India&#8217;s primary\nregulatory body for pharmaceuticals and medical devices, falling under the\nMinistry of Health and Family Welfare&#8217;s Directorate General of Health Services.<\/li><li><strong>Drug\nController General of India (DCGI):<\/strong> It is the head of CDSCO and is in\ncharge of overseeing clinical trials and approving high-quality medications and\ncosmetics for national distribution.<\/li><li><strong>The Drugs\nand Cosmetic Act and Rules:<\/strong> In India, the manufacture, import, and\ndistribution of drugs are all governed by the Drugs &amp; Cosmetic Act and\nRules.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_for_CDSCO_Medical_Device_Registration_for_Digital_Thermometer\"><\/span><strong>Checklist for CDSCO Medical Device Registration for Digital Thermometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the\nchecklist for CDSCO Medical Device Registration for Digital Thermometer:<\/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\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_for_CDSCO_Medical_Device_Registration_for_Digital_thermometer\"><\/span><strong>Procedure for CDSCO Medical Device Registration for Digital thermometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Prior to 2006,\nthere were no laws or regulations governing the sale or use of medical devices\nin India. Later, CDSCO issued a regulation requiring all medical devices sold\non the market to be in compliance with CDSCO. Medical Devices must now be\nregistered with CDSCO before being manufactured, sold, or imported into the\nIndian market due to compliance requirements. The steps to take for CDSCO\nMedical Device Registration for a BP monitor in India are listed below:<\/p>\n\n\n\n<p><strong>1. Verify whether the registration of the\nmedical devices is necessary:<\/strong>&nbsp; The\napplicant must first check the Medical Devices and IVDs list to determine\nwhether the medical device has been notified. Before being marketed in India,\nall medical devices that have been notified are required to register. In this\nscenario, the digital thermometer belongs to the group of notified devices and\nneeds to be registered with CDSCO.<\/p>\n\n\n\n<p><strong>2. Risk-Based Classification of Medical\nDevices:<\/strong> Depending on the risks associated with each device, the notified\nones that must be registered with CDSCO are then determined. A digital\nthermometer involves a Medium level of risk, placing it in Class B of the\nrisk-based classification of medical devices.<\/p>\n\n\n\n<p><strong>3. Appointment of Indian Authorized Agent<\/strong>:\nIn the event that the manufacturer is not an Indian, an IAA, or Indian\nAuthorized Agent, has been named. The IAA, who serves as the manufacturer&#8217;s\nofficial representative in court, carries out all of his business in India.<\/p>\n\n\n\n<p><strong>4. Documentation Procedure:<\/strong> To obtain a\nregistration licence, all required paperwork must be submitted to the\nappropriate authorities.<\/p>\n\n\n\n<p><strong>5. Receiving Registration and License:<\/strong>\nAfter submitting all required documents to the appropriate authorities, the\nmanufacturer receives the registration licence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_CDSCO_Medical_Device_Registration_for_Digital_Thermometer\"><\/span><strong>Timeline for CDSCO Medical Device Registration for Digital Thermometer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After submitting\nthe application, the CDSCO Medical Device Registration for Digital Thermometers\ntypically takes six to nine months to complete. Three years are allowed for\nregistration to be valid. If the registration needs to be renewed, the renewal\napplication must be submitted six months before the current registration\nexpires.<\/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>Digital thermometers are temperature-measuring tools with permanent probes and a digital display that makes them easy to carry around. Medical Devices are required to be registered with CDSCO before being marketed in India, in accordance with the Medical Devices Rules of 2017, which makes CDSCO Medical Device Registration for Digital Thermometer mandatory. Although, Even a slight registration application error can result in the application being rejected. In light of this, it is always advisable to seek professional assistance with CDSCO Medical Device Registration for Digital Thermometer.<\/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-bp-monitor\/\">CDSCO Medical Device Registration for BP Monitor<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Central Drug Standard Control Organization, or CDSCO, is the National Regulatory Authority of India and is responsible for the regulation of Medical Devices, IVDs and Drugs in India. It works under the Ministry of Health and Family Welfare, which is regulated by the Directorate General of Health Services under the Indian Government. CDSCO is also [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48240,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2694],"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":3892,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48239"}],"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=48239"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48239\/revisions"}],"predecessor-version":[{"id":48250,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48239\/revisions\/48250"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48240"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}