{"id":50469,"date":"2022-11-02T12:38:05","date_gmt":"2022-11-02T07:08:05","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50469"},"modified":"2024-11-04T17:46:10","modified_gmt":"2024-11-04T12:16:10","slug":"cdsco-registration-for-oncology-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-oncology-medical-devices\/","title":{"rendered":"CDSCO Registration for Oncology Medical Devices &#8211; An Overview"},"content":{"rendered":"\n<p>The CDSCO is the national regulatory body for pharmaceutical, medical, and cosmetic goods. The Indian Government plans to bring all <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical devices<\/strong><\/a> under the purview of the CDSCO to regulate and ensure the quality, safety and performance of medical devices. Scroll down to check more information regarding CDSCO Registration for Oncology 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-registration-for-oncology-medical-devices\/#What_are_Oncology_Medical_Devices\" >What are Oncology 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\/cdsco-registration-for-oncology-medical-devices\/#Risk_Classification_System_in_India\" >Risk Classification System 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-registration-for-oncology-medical-devices\/#Documents_Required_for_CDSCO_Registration_for_Oncology_Medical_Devices\" >Documents Required for CDSCO Registration for Oncology Medical Devices&nbsp;<\/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-registration-for-oncology-medical-devices\/#CDSCO_Registration_for_Oncology_Medical_Devices_%E2%80%93_Procedure\" >CDSCO Registration for Oncology Medical Devices &#8211; Procedure<\/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-registration-for-oncology-medical-devices\/#Conclusion\" >Conclusion&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_Oncology_Medical_Devices\"><\/span>What are Oncology Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before we dig into the<strong><a href=\"https:\/\/corpbiz.io\/cdsco-registration\"> CDSCO Registration<\/a><\/strong> for Oncology Medical Devices, lets understand the meaning of Oncology Medical Devices. Oncology refers to the branch of medicine concerned with the diagnostics and treatment of cancerous diseases. The term &#8216;medical device&#8217; can refer to any device\/apparatus\/instrument as such that is used in medical practices on humans or animals, with specific intended purposes related to analysis, treatment, prevention, etc., of physiological afflictions. Several medical devices exist to aid, primarily, in diagnosing cancer patients and to map the severity of the affliction; these are referred to as Oncology Medical Devices. Imaging technologies such as MRIs, PET Scans, ultrasounds, etc., are regularly used by oncologists to diagnose cancerous diseases and growths such as tumours.<\/p>\n\n\n\n<p>Currently, only certain medical devices notified under the <strong>Drugs &amp; Cosmetics Act 1940<\/strong><sup><a href=\"https:\/\/www.indiacode.nic.in\/bitstream\/123456789\/2409\/1\/a1940-23.pdf\"><strong>[1]<\/strong><\/a><\/sup> are regulated. In 2020, The CDSCO provided a list of Oncology Medical Devices, which consisted of 31 devices and classified them based on their intended use and risk class. As of October 2022, all Medical Devices labelled under Risk Class A or B will require CDSCO licensing. Importers of Oncology Medical Devices would require a licence from the CDSCO to sell their products in India. The comprehensive list is available online on the CDSCO webpage.<\/p>\n\n\n\n<p>Applicants must start their\napplication through the registration link made available on the CDSCO online\nportal. While Class A and B devices have now begun to fall under the licencing\nregime as of October 2022, Class C and D devices will follow the same pattern\nand fall under the licencing regime from October 2023. <\/p>\n\n\n\n<p>For devices already in the market\nbefore the CDSCO notification, the manufacturer and\/or importer must comply\nwith the CDSCO rules and register the oncology medical device within the\nspecified period after the device is notified under the CDSCO list.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk_Classification_System_in_India\"><\/span>Risk Classification System in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>All medical devices have been classified under four\ncategories, based on their use and the risk involved, under the New Medical\nRules 2017. The following table depicts these four categories, known as Risk\nClasses. <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Risk Class<\/strong>\n  <\/td><td>\n  <strong>Risk Level<\/strong>\n  <\/td><td>\n  <strong>Examples<\/strong>\n  <\/td><\/tr><tr><td>\n  A\n  <\/td><td>\n  Low risk\n  <\/td><td>\n  Wheelchairs or\n  tongue depressors\n  <\/td><\/tr><tr><td>\n  B\n  <\/td><td>\n  Low to moderate\n  risk\n  <\/td><td>\n  Hypodermic needles\n  or suction equipment\n  <\/td><\/tr><tr><td>\n  C\n  <\/td><td>\n  Moderate to high\n  risk\n  <\/td><td>\n  Ventilators or bone\n  fixation plates\n  <\/td><\/tr><tr><td>\n  D\n  <\/td><td>\n  High risk\n  <\/td><td>\n  Heart valves or\n  implantable defibrillators\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><strong><em>A variety of factors affect the classification\nlevel of Oncology Medical Devices, such as-.<\/em><\/strong><strong><em><\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>The duration of contact the medical device has with the body.<\/li>\n\n\n\n<li>The degree of invasiveness.<\/li>\n\n\n\n<li>Whether the medical device delivers energy or any medicinal products to the patient.<\/li>\n\n\n\n<li>If the device is intended to have a biological effect on the patient.<\/li>\n\n\n\n<li>Local versus systemic effects (e.g. conventional versus absorbable sutures).<\/li>\n<\/ul>\n\n\n\n<p>In the case of a collection of\nmedical devices that comply with all regulatory requirements individually, the\nrisk classification for the collective depends on the owner\u2019s purpose for\npackaging and marketing.<\/p>\n\n\n\n<p>Any accessories aimed specifically\nat helping a particular Oncology Medical Device function will be subject to the\nsame regulatory practices as the main device itself.&nbsp;<\/p>\n\n\n\n<p>Any software that is not embedded\ninto the Medical Device itself is considered standalone software and can be\ndeemed to fall under the scope of a Medical Device. Hence, such standalone\nsoftware is then subject to classification as follows-<\/p>\n\n\n\n<ul>\n<li>If the software drives or influences the use of a separate medical device, its classification depends on the intended purpose of the combination.<\/li>\n\n\n\n<li>If the software is independent of any other medical device, it is classified as its own device accordingly to the classification rules.<\/li>\n\n\n\n<li>Standalone software is deemed to be an active medical device.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Registration_for_Oncology_Medical_Devices\"><\/span>Documents Required for CDSCO Registration for Oncology Medical Devices&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some vital documents required for CDSCO\nRegistration for Oncology Medical Devices:<\/p>\n\n\n\n<p><strong>Pre-screening\nchecklist-CDSCO Registration for Oncology Medical Devices<\/strong><strong><\/strong><\/p>\n\n\n\n<ul>\n<li>Covering Letter<\/li>\n\n\n\n<li>Self-attested copy of authorization letter to the person issued by the Director\/Company Secretary\/Partner of the Indian Agent firm<\/li>\n\n\n\n<li>Detail Product description along with the material of construction, intended use, Product specification, product literature, package inserts along with a sample<\/li>\n\n\n\n<li>The regulatory status of the said product in the country of origin<\/li>\n\n\n\n<li>Regulatory certificates in respect of said product<\/li>\n<\/ul>\n\n\n\n<p><strong>To\nregister on the online portal-<\/strong><strong><\/strong><\/p>\n\n\n\n<ul>\n<li>Id Proof Details<\/li>\n\n\n\n<li>Undertaking<\/li>\n\n\n\n<li>Corporate Address Proof Details (Certificate of Incorporation)<\/li>\n\n\n\n<li>Copy of the Manufacturing Licence and the Wholesale Licences <\/li>\n<\/ul>\n\n\n\n<p><strong>For\nRegistration of devices by the manufacturer-<\/strong><strong><\/strong><\/p>\n\n\n\n<ul>\n<li>Name &amp; address of the company\/firm\/any other entity manufacturing the medical device, along with the name &amp; address of the manufacturing site of the medical device.<\/li>\n\n\n\n<li>Details of the medical device.<\/li>\n\n\n\n<li>Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies\/International Accreditation Forum in respect of such medical device.<\/li>\n\n\n\n<li>Undertaking duly-signed by the manufacturer stating that the information provided by the applicant is true and authentic.<\/li>\n<\/ul>\n\n\n\n<p><strong>For\nRegistration of devices by the importers-<\/strong><strong><\/strong><\/p>\n\n\n\n<ul>\n<li>Name of the company\/firm\/any other entity importing the medical device.<\/li>\n\n\n\n<li>Details of the medical device.<\/li>\n\n\n\n<li>Specification and standards of that medical device.<\/li>\n\n\n\n<li>Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies\/International Accreditation Forum in respect of such medical device.<\/li>\n\n\n\n<li>Free sale certificate from country of origin.<\/li>\n\n\n\n<li>Undertaking duly-signed by the importer stating that the information provided by the applicant is authentic.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Registration_for_Oncology_Medical_Devices_%E2%80%93_Procedure\"><\/span>CDSCO Registration for Oncology Medical Devices &#8211; Procedure<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the procedure for CDSCO Registration\nfor Oncology Medical Devices:<\/p>\n\n\n\n<ol>\n<li><strong>Identify Whether a Medical Device needs to be registered<\/strong>: The CDSCO has provided a list of notified medical devices that require Registration under the <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drugs <\/strong><\/a>&amp; Cosmetics Act, 1940 and as per MDR, 2017. However, there may be any medical devices that haven&#8217;t been notified by the CDSCO, or in the case of a new medical device, the manufacturer or importer shall be required to get a <strong><a href=\"https:\/\/corpbiz.io\/noc-from-assistant-drug-controller\">NOC<\/a><\/strong> in such cases.<\/li>\n\n\n\n<li>Appoint an IAA: In\nthe case of a Foreign Manufacturer, an Indian Authorised Agent is appointed.\nThe Indian Authorised Agent or IAA represents the manufacturer in court &amp;\ncarries out all of their official business in India.<\/li>\n\n\n\n<li>Documentation: To\nObtain a CDSCO Registration License, all required documents must be submitted\nto the concerned authorities.<\/li>\n\n\n\n<li>Issuance of\nLicense: The manufacturer gets the Registration License after submitting the\napplication &amp; all the required documents to the appropriate authorities.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>At present, all Medical Devices labelled under Risk Class A or B will require CDSCO licensing, but come October 2023, Class C and D devices will follow the same pattern and fall under the licence regime.<\/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-registration-for-general-hospital-medical-devices\/\">CDSCO Registration for General Hospital Medical Devices \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CDSCO is the national regulatory body for pharmaceutical, medical, and cosmetic goods. The Indian Government plans to bring all medical devices under the purview of the CDSCO to regulate and ensure the quality, safety and performance of medical devices. Scroll down to check more information regarding CDSCO Registration for Oncology Medical Devices. What are [&hellip;]<\/p>\n","protected":false},"author":46,"featured_media":50481,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2822],"acf":{"service_id":"508"},"authorName":"Jahnvi Shrivastava","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/10\/MicrosoftTeams-image-244.jpg","authorDescription":"Jahnvi Shrivastava has done her MA in English Literature from the University of Leeds and her BA in the same from Jesus and Mary College, DU. She has an excellent grasp of the English language and a love for reading which have both led to her pursuing a career in writing. Due to her background in academics and editing she has developed a keen eye for details and a good mind for research. She loves to work with and write a wide variety of topics and aims to hone her skills further through her experience.","postViews":2898,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50469"}],"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\/46"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50469"}],"version-history":[{"count":5,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50469\/revisions"}],"predecessor-version":[{"id":67121,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50469\/revisions\/67121"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50481"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50469"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50469"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50469"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}