{"id":12008,"date":"2022-09-21T06:00:25","date_gmt":"2022-09-21T06:00:25","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=12008"},"modified":"2022-09-21T06:00:27","modified_gmt":"2022-09-21T06:00:27","slug":"what-are-the-different-classes-of-medical-devices-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/what-are-the-different-classes-of-medical-devices-in-india\/","title":{"rendered":"What are the Different classes of medical devices in India?"},"content":{"rendered":"\n<p>In the year 2017, the ministry of health\nand family welfare introduced new rules for Medical devices. The new rules have\nbeen created to bring the regulations at par with the Global Harmonisation Task\nForce (GHTF) and international practices. Initially, the government had only\nmarked 15 devices to be regulated as drugs. This number has now been increased\nto 37 medical devices. The new rules have been brought in to ease the\nregulatory process for manufacturers in India and also to support the ease of\ndoing business. These steps shall enhance the production of medical devices in\nthe country and, at the same time, provide better care and safety. CDSCO is the\norganisation responsible for overseeing the affairs related to the\nclassification of medical devices. In this blog, we shall look at the Different\nclasses of medical devices and their risk levels.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3a8c83b4c3f\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3a8c83b4c3f\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-the-different-classes-of-medical-devices-in-india\/#Need_for_device_quality_Regulation_in_India\" title=\"Need for device quality Regulation in India \">Need for device quality Regulation in India <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-the-different-classes-of-medical-devices-in-india\/#The_List_of_Devices_under_the_regulations\" title=\"The List of Devices under the regulations \">The List of Devices under the regulations <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-the-different-classes-of-medical-devices-in-india\/#Different_classes_of_medical_devices_as_per_CDSCO\" title=\"Different classes\nof medical devices as per CDSCO\">Different classes\nof medical devices as per CDSCO<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/blog\/what-are-the-different-classes-of-medical-devices-in-india\/#Conclusion\" title=\"Conclusion: \">Conclusion: <\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Need_for_device_quality_Regulation_in_India\"><\/span>Need for device quality Regulation in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The law that governs the registration of medical devices in India is<strong> the Drugs and Cosmetics Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>. However, the issue is that the act is applicable only to the &#8220;drug&#8221;. Only those medical devices categorised as drugs (a.k.a Notified medical devices) shall be under the ambit of this act. The government introduced the Medical devices rules 2017 under the drugs and cosmetics act, and the rules also created Different classes of medical devices. These rules have to be followed by the stakeholders such as importers, marketers, manufacturers and sellers. <\/p>\n\n\n\n<p>The Drugs and Cosmetics act and Medical\ndevices Rules have made it mandatory for all stakeholders to have a mandatory\nlicense before carrying out any activity related to medical devices. The\nlicense issuance depends on stringent quality checks and periodic inspections.\nThe license holder is also required to maintain track of their products so that\nthe authorities can trace the device in case of any complaint or failure.<br>\n<br>\nImpact of medical devices\nRegistration in India<\/p>\n\n\n\n<p><strong>Mandatory\nCompliance:<\/strong><\/p>\n\n\n\n<p>The medical device registration keeps a tab on the investigation, performance evaluation, import, manufacture and sale. <strong><a href=\"https:\/\/swaritadvisors.com\/cdsco-cosmetic-import-registration\" class=\"text-primary\">CDSCO <\/a><\/strong>is involved in each of the steps. Therefore the level of compliance by the concerned stakeholder significantly increases. If the license holder fails to comply with norms, then his license can be revoked.<\/p>\n\n\n\n<p><strong>Quality\nControl Measures:&nbsp; <\/strong><\/p>\n\n\n\n<p>Medical device registration also requires\nthe license holder to ensure that their devices pass strict quality control\nmeasures. The devices are required to follow the control norms set forth by the\nBureau of Indian Standards, and in case there are no BIS norms for it, then\nregulations laid down the Health ministry shall be followed.<\/p>\n\n\n\n<p><strong>Price\nControl:<\/strong><\/p>\n\n\n\n<p>The price of all the drugs shall be\nregulated by the authorities. Once a medical device is registered, then it\nshall come under the purview of Drugs (Prices and Control Order, 2013). There\nmight be a cap of 10% on the price of the device, or a fixed ceiling price\nshall be introduced.<\/p>\n\n\n\n<p><strong>Greater\nInvolvement by the Ministry of Health<\/strong><\/p>\n\n\n\n<p>The ministry of health shall have a\nconstant watch over the devices that are under the umbrella of the\nregistration. This mechanism makes it easier for the ministry to implement\nstandards, effectively regulate current ones, and even ban certain practices\nthat might harm consumers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_List_of_Devices_under_the_regulations\"><\/span>The List of Devices under the regulations <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per the rules, the following products shall be allotted into different classes of medical devices:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  S.no\n  <\/td><td>\n  Product \n  <\/td><\/tr><tr><td>\n  1.\n  <\/td><td>  Disposable Hypodermic Syringes;   <\/td><\/tr><tr><td>\n  2.\n  <\/td><td> Disposable Hypodermic Needles   <\/td><\/tr><tr><td>\n  3.\n  <\/td><td> Disposable Perfusion Sets   <\/td><\/tr><tr><td>\n  4.\n  <\/td><td>Substances used for in vitro diagnosis including Blood Grouping Sera   <\/td><\/tr><tr><td>\n  5.\n  <\/td><td>Cardiac Stents   <\/td><\/tr><tr><td>\n  6.\n  <\/td><td> Drug-Eluting Stents   <\/td><\/tr><tr><td>\n  7.\n  <\/td><td> Catheters   <\/td><\/tr><tr><td>\n  8.\n  <\/td><td> Intra Ocular Lenses   <\/td><\/tr><tr><td>\n  9.\n  <\/td><td>\n  I.V.\n  Cannulae\n  <\/td><\/tr><tr><td>\n  10.\n  <\/td><td>   Bone Cement   <\/td><\/tr><tr><td>\n  11.\n  <\/td><td>   Heart  Valves   <\/td><\/tr><tr><td>\n  12.\n  <\/td><td>   Scalp Vein Set   <\/td><\/tr><tr><td>\n  13.\n  <\/td><td>   Orthopedic Implants   <\/td><\/tr><tr><td>\n  14.\n  <\/td><td>   Internal Prosthetic Replacements   <\/td><\/tr><tr><td>\n  15.\n  <\/td><td>   Ablation Devices   <\/td><\/tr><tr><td>\n  16.\n  <\/td><td>   Ligatures, Sutures and Staplers   <\/td><\/tr><tr><td>\n  17.\n  <\/td><td>   Intra Uterine Devices (Cu-T)   <\/td><\/tr><tr><td>\n  18.\n  <\/td><td>\n  Condoms\n  <\/td><\/tr><tr><td>\n  19.\n  <\/td><td>\n  Tubal Rings\n  <\/td><\/tr><tr><td>\n  20.\n  <\/td><td>   Surgical Dressings   <\/td><\/tr><tr><td>\n  21.\n  <\/td><td>   Umbilical tapes   <\/td><\/tr><tr><td>\n  22.\n  <\/td><td>   Blood\/Blood Component Bags   <\/td><\/tr><tr><td>\n  23.\n  <\/td><td>   Organ Preservative Solution   <\/td><\/tr><tr><td>\n  24.\n  <\/td><td>\n  Nebulizer\n  <\/td><\/tr><tr><td>\n  25.\n  <\/td><td>   Blood Pressure Monitoring Device   <\/td><\/tr><tr><td>\n  26.\n  <\/td><td>\n  Glucometer\n  <\/td><\/tr><tr><td>\n  27.\n  <\/td><td>\n  Digital\n  Thermometer\n  <\/td><\/tr><tr><td>\n  28.\n  <\/td><td>\n  All\n  implantable medical devices Equipment\n  <\/td><\/tr><tr><td>\n  29.\n  <\/td><td>   CT Scan Equipment   <\/td><\/tr><tr><td>\n  30.\n  <\/td><td> MRI Equipment   <\/td><\/tr><tr><td>\n  31.\n  <\/td><td> Defibrillators   <\/td><\/tr><tr><td>\n  32.\n  <\/td><td> PET Equipment   <\/td><\/tr><tr><td>\n  33.\n  <\/td><td> X-Ray Machine   <\/td><\/tr><tr><td>\n  34.\n  <\/td><td> Dialysis Machine\u00a0   <\/td><\/tr><tr><td>\n  35.\n  <\/td><td>Bone marrow cell separator   <\/td><\/tr><tr><td>\n  36.\n  <\/td><td>Disinfectants   and insecticides specified in Medical Devices Rules   <\/td><\/tr><tr><td>\n  37.\n  <\/td><td>Ultrasound equipment   <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_classes_of_medical_devices_as_per_CDSCO\"><\/span><strong>Different classes\nof medical devices as per CDSCO<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The classification of the medical devices\nare based on the risk the device carries. The risk here is depended upon the\nnature of the device and the intended use of it. Different classes of medical\ndevices are as follows:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td><strong> S.no<\/strong>   <\/td><td>  <strong>Class<\/strong>   <\/td><td>   <strong>Risk Type<\/strong>   <\/td><td>   <strong>Devices<\/strong>   <\/td><\/tr><tr><td>\n  1.\n  <\/td><td>Class A   <\/td><td>\n  Low\n  <\/td><td>   Alcohol swabs, cotton wools and surgical dressing etc.   <\/td><\/tr><tr><td>\n  2.\n  <\/td><td>Class B   <\/td><td>\n  Low Moderate Risk\n  <\/td><td>   BP monitoring device, thermometer, glucometer etc.   <\/td><\/tr><tr><td>\n  3.\n  <\/td><td>Class C   <\/td><td>   Moderate-High Risk   <\/td><td>   Implants, cardiac stents. Bone cement etc.   <\/td><\/tr><tr><td>\n  4.\n  <\/td><td>Class D   <\/td><td>\n  High Risk\n  <\/td><td>The angiographic guide wire, heart valves Etc.   <\/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>The New medical policy by the CDSCO was introduced to strengthen the regulations around medical devices. The medical device registration shall ensure that the manufacturers and other stakeholders produce quality products. The regulations are a small step towards bringing Indian medical standards to par with international standards. With proper implementation, the medical device registration will be able to reduce harm which can be caused by faulty medical apparatus.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/clinical-performance-evaluation-for-new-ivd-medical-device\/\">Clinical Performance Evaluation for New IVD Medical Device<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the year 2017, the ministry of health and family welfare introduced new rules for Medical devices. The new rules have been created to bring the regulations at par with the Global Harmonisation Task Force (GHTF) and international practices. Initially, the government had only marked 15 devices to be regulated as drugs. This number has [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":12012,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12008"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=12008"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12008\/revisions"}],"predecessor-version":[{"id":12014,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/12008\/revisions\/12014"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/12012"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=12008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=12008"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=12008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}