{"id":51637,"date":"2023-01-06T11:56:13","date_gmt":"2023-01-06T06:26:13","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51637"},"modified":"2024-11-04T18:08:53","modified_gmt":"2024-11-04T12:38:53","slug":"cdsco-registration-for-cardiovascular-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-cardiovascular-medical-devices\/","title":{"rendered":"CDSCO Registration for Cardiovascular Medical Devices"},"content":{"rendered":"\n<p>The medical device industry in India is predicted to\nexpand over the next several years as a result of greater health awareness, a\ngrowing middle-class population, and government health programmes. With the\nrelease of the Medical Device Rules in 2017, Indian authorities completely\naltered the medical device regulatory procedure. The Central Drugs Standard\nControl Organisation, also called CDSCO, is a National Regulatory Authority of\nIndia. It comes under the preview of the Directorate General of Health Services\n(DGHS) under the Ministry of Health &amp; Family Welfare. Additionally, CDSCO\nand state regulators are jointly in charge of issuing licences for certain specialized\ncategories of drugs, including vaccines, blood and blood products, IV fluids,\nand sera. In this article, we will discuss <strong>CDSCO Registration for Cardiovascular Medical\nDevices.<\/strong><\/p>\n\n\n\n<p>Every year, cardiovascular medical devices such as\nartificial heart valves, coronary stents, endovascular grafts, and angioplasty\nballoon catheters save thousands of lives. The use of these devices helps to\nidentify and treat heart disease and other related health issues. However, for device manufacturers, designing, developing, and\nproducing new&nbsp;implantable cardiovascular devices is a challenging, time-consuming,\nand expensive process.<\/p>\n\n\n\n<p>Prior to 2005, India had no regulations governing medical devices.\nToday, however, there are registration processes for specific medical device\ntypes that are covered by the Medical Device Rules. While the list of regulated\nproducts is exhaustive, the CDSCO occasionally adds products to the list.\nBefore marketing your product in India, you must first ascertain whether it is\ngoverned by the CDSCO. <\/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-cardiovascular-medical-devices\/#Regulatory_Compliance_for_Cardiovascular_Medical_Devices\" >Regulatory Compliance\nfor Cardiovascular 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-cardiovascular-medical-devices\/#What_Documents_Are_Required_For_CDSCO_Registration_For_Cardiovascular_Medical_Devices\" >What Documents Are Required For CDSCO\nRegistration For Cardiovascular 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\/cdsco-registration-for-cardiovascular-medical-devices\/#Procedure_for_CDSCO_Registration_for_Cardiovascular_Medical_Devices\" >Procedure for CDSCO Registration for\nCardiovascular Medical Devices<\/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-cardiovascular-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Compliance_for_Cardiovascular_Medical_Devices\"><\/span>Regulatory Compliance\nfor Cardiovascular Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The term medical devices\nare mentioned under <em>Section 3 (b) (iv<\/em>)\nof the Drugs &amp; Cosmetics Act. Medical\ndevices are classified into four different risk classes, namely Class A, Class\nB, Class C &amp; Class D. Recently, CDSCO issued a clarification on\ncardiovascular medical devices classification. As per the notice dated: July\n26, 2021, DGI issued a list of classification of medical devices pertaining to\ncardiovascular under the provision of the Medical Devices rule, 2017.<\/p>\n\n\n\n<p>Cardiovascular devices are classified into a number of classes as per intended use and the risk associated with them. Pacemakers and other cardiovascular medical devices now require <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">CDSCO Medical Device Registration<\/a><\/strong>. To register the pacemaker or other cardiovascular devices, manufacturers need to classify their devices first and then need to submit the list of necessary documents to the respective department. If a manufacturer is not Indian, then he\/she needs to appoint IAA Indian authorized agent who represents the manufacturer and carries business in India.<\/p>\n\n\n\n<ul>\n<li><strong>Classification\nOf Medical Devices Pertaining To Cardiovascular<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Mentioned below is the list of all the medical devices\npertaining to cardiovascular with their risk category;<\/p>\n\n\n\n<figure class=\"wp-block-table table table-bordered\"><table><tbody><tr><td>\n  <strong>&nbsp;<\/strong>\n  <strong>Medical Device Name<\/strong>\n  <strong>&nbsp;<\/strong>\n  <\/td><td>\n  <strong>Risk\n  Class<\/strong>\n  <\/td><\/tr><tr><td>\n  Arrhythmia Detector And\n  Alarm (Including St-Segment Measurement And Alarm)\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cardiac monitor\n  (including cardiotachometer and rate alarm)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Apexcardiograph\n  (vibrocardiograph)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Echocardiography\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Electrocardiograph\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Electrocardiograph\n  electrode\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Vascular clip\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Vena cava clip\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Intra-aortic balloon\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Intra-aortic balloon\n  control system (balloon pump)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Ventricular bypass\n  (assist) device\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Pacing system analyzer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  An implantable\n  pacemaker pulse generator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Pacemaker lead adaptor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Pacemaker generator\n  function analyzer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cardiovascular\n  permanent or temporary pacemaker electrode\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Pacemaker test magnet\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Pacemaker programmers\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Pacemaker repair or\n  replacement material\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Annuloplasty ring\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Carotid sinus nerve\n  stimulator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Replacement heart valve\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Endomyocardial biopsy\n  device\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Extracorporeal circuit\n  and accessories for long-term respiratory\/cardiopulmonary failure\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  bubble detector\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  vascular catheter, cannula, or tubing\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  heart-lung machine console\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  defoam\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  heat exchanger\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  temperature controller\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  arterial line blood filter\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  cardiotomy suction line blood\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Cardiopulmonary bypass\n  pulsatile flow generator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Intraluminal artery\n  stripper\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  External cardiac\n  compressor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  External transcutaneous\n  cardiac pacemaker\n  <\/td><td>\n  C\n  <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Documents_Are_Required_For_CDSCO_Registration_For_Cardiovascular_Medical_Devices\"><\/span>What Documents Are Required For CDSCO\nRegistration For Cardiovascular Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the exhaustive list of documents needed for CDSCO registration for cardiovascular medical\ndevices: <\/p>\n\n\n\n<ul>\n<li>Application form\nfor registration<\/li>\n\n\n\n<li>Challan TR6;<\/li>\n\n\n\n<li>ISO 13485;<\/li>\n\n\n\n<li>Power of Attorney;<\/li>\n\n\n\n<li>An Undertaking stating\nthat only accurate information or details are provided;<\/li>\n\n\n\n<li>Certificate of\nquality assurance;<\/li>\n\n\n\n<li>C.E. Design\nAccreditation;<\/li>\n\n\n\n<li>Declaration of\nConformity;<\/li>\n\n\n\n<li>Schedule D(I);<\/li>\n\n\n\n<li>Master Plant File\nor MPF;<\/li>\n\n\n\n<li>Device Master File\nor DMF;<\/li>\n\n\n\n<li>Free Sale\nCertificate (FSC);<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_Cardiovascular_Medical_Devices\"><\/span>Procedure for CDSCO Registration for\nCardiovascular Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Applications for both notified and non-notified medical devices must be filed via the online SUGAM portal, which is also used by <strong><a href=\"https:\/\/corpbiz.io\/cdsco\">CDSCO<\/a><\/strong> to manage applications.<\/p>\n\n\n\n<p>Previously,\nmanufacturers were allowed to sell medical devices in India without being\nsubject to any regulations. Since 2006, the CDSCO&#8217;s Indian Medical Device\nRegulations have applied to medical devices entering the Indian market. <\/p>\n\n\n\n<p><strong><em>Mentioned\nbelow is a step-by-step process for <\/em><\/strong><strong><em>CDSCO registration for cardiovascular medical\ndevices: <\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>The 1st step is to\ndetermine whether your product requires registration.<\/li>\n\n\n\n<li>Appoint an\nauthorized Indian agent:<\/li>\n\n\n\n<li>A manufacturer can\nappoint an authorized Indian agent for CDSCO registration for cardiovascular\nmedical devices. <\/li>\n<\/ul>\n\n\n\n<p><strong>Eligibility to be an authorized Indian agent for CDSCO Registration for\nCardiovascular Medical Devices:<\/strong><\/p>\n\n\n\n<ol>\n<li>Must be a Resident of India<\/li>\n\n\n\n<li>Must have years of experience in the healthcare industry<\/li>\n\n\n\n<li>Must hold Power of Attorney to submit Medical Device Registration documents to CDSCO<\/li>\n\n\n\n<li>Must hold <strong><a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\">wholesale drug licenses<\/a><\/strong> in forms 20B and 21B. <\/li>\n<\/ol>\n\n\n\n<ul>\n<li>Submit the duly-filled application form along with the required documents.<\/li>\n\n\n\n<li>Obtain a registration certificate.<\/li>\n\n\n\n<li>After the documents for <a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration<\/strong><\/a> for Cardiovascular Medical Devices are submitted, CDSCO will get back to the Indian Agent (Authorised Representative) with a query letter (if any). If the responses or replies given by the agent are satisfactory to the CDSCO, the licence will be granted. <\/li>\n\n\n\n<li>The certificate for CDSCO Registration for Cardiovascular Medical Devices is valid for a term of three years. <\/li>\n<\/ul>\n\n\n\n<p>Following forms are used for CDSCO Registration for Cardiovascular Medical Devices in India:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Type of\n  Applicant<\/strong>\n  <\/td><td>\n  <strong>Class of\n  Medical Device<\/strong>\n  <\/td><td>\n  <strong>Application\n  Form<\/strong>\n  <\/td><td>\n  <strong>License Form<\/strong>\n  <\/td><\/tr><tr><td>\n  Manufacturer\n  <\/td><td>\n  A,B\n  <\/td><td>\n  MD-3\n  <\/td><td>\n  MD-5\n  <\/td><\/tr><tr><td>\n  Importer\n  <\/td><td>\n  A,B,C,D\n  <\/td><td>\n  MD-14\n  <\/td><td>\n  MD-15\n  <\/td><\/tr><tr><td>\n  Manufacturer (Loan License)\n  <\/td><td>\n  A,B\n  <\/td><td>\n  MD-4\n  <\/td><td>\n  MD-6\n  <\/td><\/tr><tr><td>\n  Manufacturer\n  <\/td><td>\n  C,D\n  <\/td><td>\n  MD-7\n  <\/td><td>\n  MD-9\n  <\/td><\/tr><tr><td>\n  Manufacturer (Loan License)\n  <\/td><td>\n  C,D\n  <\/td><td>\n  MD-8\n  <\/td><td>\n  MD-10\n  <\/td><\/tr><\/tbody><\/table>\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>Medical devices are a\nvital component of healthcare, yet they are a remarkably diverse class of\ngoods. They can be broadly categorized as preventative care devices, assistive\ncare devices, diagnostic devices, and therapeutic devices based on their functions.\nThe Indian medical device industry is Asia&#8217;s fourth-largest market.<\/p>\n\n\n\n<p>According to the terms of <strong>the Medical Device Rules, 2017<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Acts-and-rules\/Medical-Devices-Rules\/\"><strong>[1]<\/strong><\/a><\/sup>, enacted by the government under the <strong><a href=\"https:\/\/corpbiz.io\/drug-license\">Drugs<\/a><\/strong> and Cosmetics Act, 1940, medical devices are regulated as drugs in India by the Central Drugs Standards Control Organization (CDSCO). Only the devices that the government has notified are governed and fall within the MDR17 regulations. The 2017 Rules adopted a risk-based classification approach for medical device regulation, with Low Risk (Class A), Low Moderate (Class B), Moderate High (Class C), and High-Risk devices classed as (Class D). <\/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-pacemaker\/\">CDSCO Medical Device Registration For Pacemaker: Complete Guide<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The medical device industry in India is predicted to expand over the next several years as a result of greater health awareness, a growing middle-class population, and government health programmes. With the release of the Medical Device Rules in 2017, Indian authorities completely altered the medical device regulatory procedure. The Central Drugs Standard Control Organisation, [&hellip;]<\/p>\n","protected":false},"author":48,"featured_media":51641,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[3003],"acf":{"service_id":"508"},"authorName":"Astitva Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/12\/MicrosoftTeams-image-27.jpg","authorDescription":"Astitva Kumar is an advocate by profession and has completed her BBA. LLB from IP University. She is an avid reader, researcher, and legal writer. Her areas of interest include mediation, conflict resolution, finance, cyber laws, and taxation.","postViews":3658,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51637"}],"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\/48"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51637"}],"version-history":[{"count":8,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51637\/revisions"}],"predecessor-version":[{"id":67129,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51637\/revisions\/67129"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51641"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51637"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51637"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51637"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}