{"id":48139,"date":"2022-09-03T12:53:17","date_gmt":"2022-09-03T07:23:17","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48139"},"modified":"2022-09-03T12:54:23","modified_gmt":"2022-09-03T07:24:23","slug":"cdsco-medical-device-registration-for-x-ray-machine","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-x-ray-machine\/","title":{"rendered":"CDSCO Medical Device Registration for X-Ray Machine"},"content":{"rendered":"\n<p>The Central Drug Standard Control Organization (CDSCO) is the <strong>National Regulatory Authority (NRA)<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/National_Health_Policy\"><strong>[1]<\/strong><\/a><\/sup> of India. It works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare, Government of India. It is regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, laying down their standards, conducting clinical trials, taking control over the quality of Imported Drugs, etc. The Ministry of consumer affairs had made a proposal to mandate the CDSCO Medical Device Registration for X-Ray Machine under Medical Device Rules, 2017, as well as under other standards set by the Bureau of Indian Standards. With effect from 1st January 2021, All the X-ray machines fall under the category of mandatory registration of CDSCO Medical Devices. <\/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-x-ray-machine\/#X-Ray_Machine_as_Medical_Device\" >X-Ray Machine 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-x-ray-machine\/#Medical_Device_Regulation_in_India\" >Medical Device Regulation 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:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-x-ray-machine\/#Classification_of_Medical_Devices_in_Medical_Device_Rules_2017\" >Classification of Medical\nDevices in Medical Device Rules, 2017<\/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-x-ray-machine\/#Regulatory_authorities_of_X-Ray_machines_as_Class_C_Medical_Devices_in_India\" >Regulatory authorities of X-Ray\nmachines as Class C Medical Devices in India<\/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-x-ray-machine\/#Documents_required_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\" >Documents required for CDSCO\nMedical Device Registration for X-Ray Machine<\/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-x-ray-machine\/#Procedure_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\" >Procedure for CDSCO Medical\nDevice Registration for X-Ray Machine<\/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-x-ray-machine\/#Timeline_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\" >Timeline for CDSCO Medical\nDevice Registration for X-Ray Machine<\/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-x-ray-machine\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"X-Ray_Machine_as_Medical_Device\"><\/span>X-Ray Machine as Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The system of medical imaging has helped in the timely treatment and diagnosis of various medical issues among patients. There are many ways of medical imaging, such as- CT, Fluoroscopy and Radiography, where all of these include ionizing radiation in order to generate body images. Body imaging devices work on one procedure, where an X-ray beam is passed through the affected body part. The X-rays are then absorbed by the internal structure, and the remaining X-ray beam reaches the detector for creating the X-ray images by the computer. <\/p>\n\n\n\n<p>X-Rays are often\nused to check images of teeth and bones, to check for any kind of breaks,\ncracks, fractures or even diseases such as arthritis. An X-ray can also be\nprescribed to check the digestive tract by evaluating the organs inside the\nchest, lungs, heart and breasts. <\/p>\n\n\n\n<p><strong>The X-Ray machines are divided into three main types-<\/strong><\/p>\n\n\n\n<ul><li>Fixed X-ray machines <\/li><li>Portable X-ray machines<\/li><li>Mobile X-ray machines <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Regulation_in_India\"><\/span>Medical Device Regulation in\nIndia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical device market sector is an important and essential part of the Healthcare sector in India, particularly for the purpose of preventing, diagnosing, managing and medical treatments of severe conditions, disabilities, diseases and Illnesses. It is an important support system in the healthcare unit and helps in achieving the important functions of the National Health Policy (NHP) 2017, and helps in providing good quality, reasonable and comprehensive healthcare services in India. <\/p>\n\n\n\n<p>According to the\nnotification number 648 (E) published in The Official Gazette of India by the\nDirectorate General of Health Services It was notified that the following\nmedical devices would be considered as Drugs from 1st April 2020-<\/p>\n\n\n\n<p>&#8220;All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either alone or in combination with other device, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one or more specific purpose of-&#8221; <\/p>\n\n\n\n<ol><li>Diagnosis, monitoring,\u00a0 prevention, alleviation or treatment of any disorder or disease <\/li><li>Diagnosis, monitoring, treatment or alleviation of any disability or Injury <\/li><li>Replacement, investigation, support or modification of a physiological process or of the anatomy<\/li><li>Life support and sustaining <\/li><li>Medical Device disinfection<\/li><li>Conception control<\/li><\/ol>\n\n\n\n<p>According to the\nnotification, the intended use of the X-ray machine is to diagnose, monitor and\ntreat any disability or Injury of the patient by capturing images of the\ninternal body structure. Therefore, CDSCO Medical Device Registration for X-Ray\nMachine is mandatory as per MDR, 2017.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_in_Medical_Device_Rules_2017\"><\/span>Classification of Medical\nDevices in Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The X-Ray device\nis classified as a Class C medical device as per the Risk-based classification\nof the Medical Device Rules, 2017. <\/p>\n\n\n\n<p>CDSCO has set up\ndifferent classes of medical devices as per their risk classification. The Drug\nController General of India (DCGI), who is the head of CDSCO, is responsible\nfor regulating different classes of medical devices as per Medical Device\nRules, 2017. The classification of the Medical Device is risk-based and is\nclassified into four types- Class A, Class B, Class C and Class D Medical\nDevice, where the level of risk increases as it moves from Class A to Class D.\nFollowing table lists the classification of medical devices on the basis of the\nrisk involved-<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Device Class <\/strong>\n  <\/td><td>\n  <strong>Risk Involved <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class A Medical Devices <\/strong>\n  <\/td><td>\n  Low Risk \n  <\/td><\/tr><tr><td>\n  <strong>Class B Medical Devices<\/strong>\n  <\/td><td>\n  Low-Medium Risk\n  <\/td><\/tr><tr><td>\n  <strong>Class C Medical Devices<\/strong>\n  <\/td><td>\n  Medium-High Risk \n  <\/td><\/tr><tr><td>\n  <strong>Class D Medical Devices<\/strong>\n  <\/td><td>\n  High Risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_authorities_of_X-Ray_machines_as_Class_C_Medical_Devices_in_India\"><\/span>Regulatory authorities of X-Ray\nmachines as Class C Medical Devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Authorities\nwho are responsible for regulating the CDSCO Medical Device Registration for\nX-Ray Machine in India are:<\/p>\n\n\n\n<ul><li>Central Drug Standards Control Organization\n(CDSCO)<\/li><li>Drug Controller General of India ( DCGI) <\/li><li>Drugs &amp; Cosmetic Act 1940 &amp; Rules 1945<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\"><\/span>Documents required for CDSCO\nMedical Device Registration for X-Ray Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Application Form (Form 40)<\/li><li><a href=\"https:\/\/corpbiz.io\/iso-13485-certification\"><strong>ISO 13485 Certificate <\/strong><\/a><\/li><li>TR6 Challan<\/li><li>Undertaking that only authentic details are provided <\/li><li>Power of attorney<\/li><li>Full quality assurance certificate <\/li><li>CE Design certificate <\/li><li>Schedule D(I) <\/li><li>Declaration of conformity<\/li><li>Device master file <\/li><li>Free sale certificate <\/li><li>Plant master report <\/li><li>Free sale certificate\/ certificate from the foreign government <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\"><\/span>Procedure for CDSCO Medical\nDevice Registration for X-Ray Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Earlier, there\nwere no rules for regulating medical devices in India, and they were sold in\nthe market without any regulations. Post-2006, the CDSCO made a rule that all\nthe medical devices circulated in the market must be in compliance with CDSCO.\nThe mandatory compliances made it important for certain Medical Devices to be\nregistered with CDSCO before manufacturing, selling or importing into the\nIndian market. Following are the steps to be followed for CDSCO Medical Device\nRegistration for X-Ray Machine in India- <\/p>\n\n\n\n<ol><li><strong>Determine\nwhether the Medical Devices require registration or not<\/strong>: The first step is\nto check with the Medical Devices and IVDs list to check if the medical device\nis notified or not. All the notified medical devices are required to obtain\nregistration before they are marketed in India. In this case, the X-Ray machines\nfall under the category of notified devices and must be registered with CDSCO &nbsp;<\/li><li><strong>Risk-Based\nClassification of Medical Devices: <\/strong>The notified devices which are required\nto be registered with CDSCO are then identified on the basis of risks involved\nwith them. The X-ray machines fall in Class C of risk-based categorization of\nMedical Devices, because they involve Medium-High level risk. <\/li><li><strong>Appointment of Indian Authorized Agent\n(IAA):<\/strong> An Indian Authorized Agent is appointed in case the manufacturer is\nnot an Indian. The IAA acts as a representative on behalf of the manufacturer\nto conduct all his official duties in India. <\/li><li><strong>Technical Documentation: <\/strong>All the\nnecessary documents are required to be submitted to the respective authorities\nin order to obtain a registration license.<\/li><li><strong>Obtain Registration and License: <\/strong>After\nall the necessary documents are submitted to the correct authorities, the\nregistration license is obtained by the manufacturer.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_CDSCO_Medical_Device_Registration_for_X-Ray_Machine\"><\/span>Timeline for CDSCO Medical\nDevice Registration for X-Ray Machine<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The general\ntimeline for CDSCO Medical Device Registration for X-Ray Machine is 6-9 months\nafter completing the application process. The registration remains valid for\nthree years. If in case of renewal, the applications are required to be\nsubmitted six months from the date of expiry. <\/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>The X-Ray machine business has grown up to 312.84 million dollars in India in the year 2021 and is expected to grow at a CAGR of 7.04% in the current period. New product launches and technological advancements are expected to create market growth for medical devices in India. Since X-Ray machine falls in the category of Class-C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for X-Ray Machine.<\/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-mri-machine\/\">How to Get CDSCO Medical Device Registration for MRI Machine?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA)[1] of India. It works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare, Government of India. It is regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, laying down their [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48140,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2686],"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":4772,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48139"}],"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=48139"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48139\/revisions"}],"predecessor-version":[{"id":48151,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48139\/revisions\/48151"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48140"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48139"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48139"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48139"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}