{"id":47211,"date":"2022-08-24T13:52:06","date_gmt":"2022-08-24T08:22:06","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47211"},"modified":"2022-08-24T13:52:08","modified_gmt":"2022-08-24T08:22:08","slug":"classification-of-rehabilitation-medical-devices-under-the-mdr-2017","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/classification-of-rehabilitation-medical-devices-under-the-mdr-2017\/","title":{"rendered":"Classification of Rehabilitation Medical Devices under the MDR, 2017"},"content":{"rendered":"\n<p>Recently, <strong><em>DCGI (Drug Controller General of India)<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_Controller_General_of_India\"><strong>[1]<\/strong><\/a><\/sup><strong><em> <\/em><\/strong>issued a notice regarding the classification of Rehabilitation Medical Devices under the Provisions of the <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Device<\/strong><\/a> Rules, 2017. The decision comes as the latest in the Drug Regulator&#8217;s (DCGI) efforts to classify the medical devices sold in the nation based on the perceived risks of the product type &amp; its use in patients. This measure is to aid the Authority in bringing all the medical devices under Regulatory Control. In July 2022, the Drug Controller General of India classified medical devices pertaining to rehabilitation and some of the same devices are mentioned in the new notice issued on 04 Aug, 2022. Scroll down to check the classification of Rehabilitation Medical Devices under the Medical Device Rules, 2017.<\/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\/classification-of-rehabilitation-medical-devices-under-the-mdr-2017\/#What_is_Rehabilitation\" >What is Rehabilitation?<\/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\/classification-of-rehabilitation-medical-devices-under-the-mdr-2017\/#Different_Classes_of_Indian_Medical_Devices\" >Different Classes of Indian\nMedical 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\/classification-of-rehabilitation-medical-devices-under-the-mdr-2017\/#New_Classification_of_Rehabilitation_Medical_Devices\" >New Classification of\nRehabilitation 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\/classification-of-rehabilitation-medical-devices-under-the-mdr-2017\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Rehabilitation\"><\/span>What is Rehabilitation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It is the\nprocess of regaining strength or relearning skills after a serious injury,\nsurgery, or illness. Rehabilitation crosses all age groups, though the type,\nlevel and goals of rehabilitation will differ depending on the individual\nneeds. Rehabilitation often focuses on:<\/p>\n\n\n\n<ol><li>Occupational therapy to help with daily\nactivities;<\/li><li>Treatment of pain;<\/li><li>Physical therapy to help with mobility, fitness,\nand strength;<\/li><li>Cognitive therapy (following head injury);<\/li><li>Speech-language therapy to help with\nunderstanding, writing, reading, and swallowing.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_Classes_of_Indian_Medical_Devices\"><\/span>Different Classes of Indian\nMedical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India,\nmedical devices are categorised into 4 different classes based on the extent of\nrisk associated with these medical devices. Below is the table of 4 different\ncategories of Medical Devices in India:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Device\n  Class<\/strong>\n  <\/td><td>\n  <strong>Risk <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class A<\/strong>\n  <\/td><td>\n  Low-Risk\n  <\/td><\/tr><tr><td>\n  <strong>Class B<\/strong>\n  <\/td><td>\n  Low Moderate Risk\n  <\/td><\/tr><tr><td>\n  <strong>Class C<\/strong>\n  <\/td><td>\n  Moderate-High Risk\n  <\/td><\/tr><tr><td>\n  <strong>Class D<\/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=\"New_Classification_of_Rehabilitation_Medical_Devices\"><\/span>New Classification of\nRehabilitation Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The DCGI\nhas released the updated classification of rehabilitation medical devices under\nthe Medical Device Rules, 2017 and you can check the same below:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Class A<\/strong>\n  <\/td><td>\n  <strong>Class B<\/strong>\n  <\/td><td>\n  <strong>Class C<\/strong>\n  <\/td><td>\n  <strong>Class D<\/strong>\n  <\/td><\/tr><tr><td>\n  Acupressure calf bandBack or leg or chest mechanical dynamometerBicycle ergometerBlue or red or infrared phototherapy lampCold compression therapy cervical spine\n  collarCold or cool therapy gelCore-body mechanical weight exerciserExothermic heat therapy packGait analysis systemMechanical hand dynamometer or pinch meterHydrotherapy treadmillManual goniometerParallel bar exerciserSilicone prosthetic earSilicone prosthetic noseExternal assembled lower limb prosthesisExternal limb prosthesis socket linerFinger or thump prosthesisTruncatal orthosisProsthesis external armCongenital hip dislocation abduction splintDenis brown splintArm slingCrutchesAbdominal support\n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  <\/td><td>\n  Arthritis TENS systemBack or leg or chest electronic dynamometerBalance-training tongue electrical\n  stimulation systemBed or chair or electric massagerBladder-emptying vibratory stimulatorCirculating-fluid thermal therapy systemCold-air therapy unitDeep-tissue electromagnetic stimulation\n  systemElectronic goniometer\/kinesiology sensorElectric hand dynamometer or pinch meterMedium-wave diathermy treatment system, Microwave diathermy treatment systemMusculoskeletal infrared phototherapy unitPhysical therapy massagerPhysical therapy paraffin wax bathPhysical therapy steam bathTelemetry diagnostic spirometerUpper extremity prosthesis consisting of a\n  simultaneously powered elbow and\/or shoulder with greater than 2 simultaneous\n  powered degrees of freedom &amp; controlled by non-implanted electrical\n  components.\n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  \n  <\/td><td>\n  Electromechanical orthopaedic extracorporeal\n  shock wave therapy systemFoot sensorimotor therapy mechanical\n  neurostimulatorInterferential electrical stimulation\n  systemMusculoskeletal intense therapeutic\n  ultrasound systemMusculoskeletal or physical therapy laserPulsed signal therapy systemA short-wave diathermy treatment systemTherapeutic nuclear magnetic resonance\n  system.\n  \n  \n  \n  \n  \n  \n  \n  <\/td><td>\n  None among the 60 devices were categorised as\n  Class D of the Regulation.\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>The DCGI\nissued a notice regarding the classification of rehabilitation medical devices\nunder the provisions of MDR, 2017 and these devices are classified with respect\nto their intended use, the risk associated with the device &amp; other\nparameters specified in the 1<sup>st<\/sup> Schedule into Classes A and B.<\/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\/when-is-import-of-medical-devices-for-personal-use-allowed\/\">When is Import of Medical Devices for Personal Use Allowed?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Recently, DCGI (Drug Controller General of India)[1] issued a notice regarding the classification of Rehabilitation Medical Devices under the Provisions of the Medical Device Rules, 2017. The decision comes as the latest in the Drug Regulator&#8217;s (DCGI) efforts to classify the medical devices sold in the nation based on the perceived risks of the product [&hellip;]<\/p>\n","protected":false},"author":35,"featured_media":47212,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2629],"acf":{"service_id":"385"},"authorName":"Karan Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/processed-1-150x150.jpeg","authorDescription":"A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.","postViews":3070,"readingTime":2,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47211"}],"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\/35"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=47211"}],"version-history":[{"count":11,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47211\/revisions"}],"predecessor-version":[{"id":47223,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47211\/revisions\/47223"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47212"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47211"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47211"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}