{"id":6609,"date":"2026-05-25T15:25:39","date_gmt":"2026-05-25T09:55:39","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6609"},"modified":"2026-05-25T15:25:39","modified_gmt":"2026-05-25T09:55:39","slug":"respiratory-medical-devices-and-regulatory-compliance","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/respiratory-medical-devices-and-regulatory-compliance\/","title":{"rendered":"Respiratory Medical Devices and Regulatory Compliance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6609\" class=\"elementor elementor-6609\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6699cd0a e-flex e-con-boxed e-con e-parent\" data-id=\"6699cd0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-410db201 elementor-widget elementor-widget-heading\" data-id=\"410db201\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Respiratory Medical Devices and Regulatory Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-51c56e13 e-flex e-con-boxed e-con e-parent\" data-id=\"51c56e13\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-730263bf e-con-full e-flex e-con e-child\" data-id=\"730263bf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4e3190af elementor-widget elementor-widget-heading\" data-id=\"4e3190af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Introduction<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4225586a elementor-widget elementor-widget-text-editor\" data-id=\"4225586a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/\"><span style=\"font-weight: 400;\">Control Drug Standard Central Organisation<\/span><\/a><span style=\"font-weight: 400;\"> (CDSCO) is India\u2019s regulatory body regulating medical device regulatory affairs and registration in India. The main aim of the <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">CDSCO<\/span><\/a><span style=\"font-weight: 400;\"> is to register the manufacturer and importers who want to sell and distribute medical devices in India in accordance with medical device regulatory affairs. On 6th Aug 2021, under the Medical Device Rule, 2017, CDSCO released the notification regarding the registration of Respiratory Devices, under which CDSCO classified fifty-one medical devices and classified them based on the intended use and risk-based classes. In 2021, the respiratory medical device market stood at USD 1005.50 million and is expected to grow at 7.12% in 2022-27 years. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2312c00d e-con-full e-flex e-con e-child\" data-id=\"2312c00d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-43fe591f e-con-full e-flex e-con e-child\" data-id=\"43fe591f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c0fa31 elementor-widget elementor-widget-heading\" data-id=\"5c0fa31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-433eaad2 elementor-widget elementor-widget-wpforms\" data-id=\"433eaad2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/gb-en\/wp-json\/wp\/v2\/posts\/6609\" data-token=\"42a4e871549e8c9e5c65553f88b5f58e\" data-token-time=\"1779932374\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Email Name Text<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6609\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4f7554cf e-flex e-con-boxed e-con e-parent\" data-id=\"4f7554cf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20ae8d02 elementor-widget elementor-widget-text-editor\" data-id=\"20ae8d02\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h5><strong>Medical Device Regulatory Affairs and Regulations has Defined Medical Devices as Device Used in the:\u00a0<br \/><br \/><\/strong><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder;\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diagnosis, monitoring, treatment, alleviation, or assistance for any injury or disability;\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The investigation, replacement or modification, or support of the anatomy or a physiological process; supporting or sustaining life;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Disinfection of medical devices; and\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Control of conception\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7c1f9fe e-flex e-con-boxed e-con e-parent\" data-id=\"7c1f9fe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-533006a elementor-widget elementor-widget-heading\" data-id=\"533006a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Classification of Medical Devices as per MDR, 2017 are: <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c9e06a elementor-widget elementor-widget-text-editor\" data-id=\"8c9e06a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><span style=\"font-weight: 400;\">Class\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Risk associated\u00a0\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low risk\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low- moderate risk\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Moderate risk\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">D\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">High Risk\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ab6d7ca e-flex e-con-boxed e-con e-parent\" data-id=\"ab6d7ca\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81d7860 elementor-widget elementor-widget-heading\" data-id=\"81d7860\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is Respiratory Medical Device?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c77e081 elementor-widget elementor-widget-text-editor\" data-id=\"c77e081\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Respiratory medical devices are devices that clear the individual\u2019s pathways to help them breathe better. Respiratory devices such as argon gas analyzers, airway tube forceps, etc., help remove substances such as mucus, blood, or saliva that create an obstruction. Sometimes the individual cannot clear the obstructions themselves and thus needs a device for the same. The respiratory medical devices are classified into four categories, but till 1st Oct 2022, only Class A and B respiratory medical device falls under this category.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-846521b e-flex e-con-boxed e-con e-parent\" data-id=\"846521b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4dcc53f elementor-widget elementor-widget-heading\" data-id=\"4dcc53f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"> Class Of Respiratory Medical Devices: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-699f15c elementor-widget elementor-widget-text-editor\" data-id=\"699f15c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><span style=\"font-weight: 400;\">Sr.No.\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Respiratory Medical Device Name\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Risk Class\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">1\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Activated-oxygen generator\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">2\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Argon gas analyzer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">3\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Artificial airway tube cuff pressure monitor\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">4\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Bulk oxygen concentration system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">5\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Cardiopulmonary resuscitation mask\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">6\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Cerebral oximeter\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">7\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Chest-oscillation airway secretion-clearing system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">8\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Chest-percussion airway secretion-clearing system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">9\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Cold-air diagnostic inhalation system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">10\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Cough long-term ambulatory recording system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">11\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Cricothyrotomy\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">12\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Dry powder inhaler\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">13\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">The dry salt therapy device\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">14\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Electroacoustic airway secretion-clearing system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">15\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Endotracheal tube introducer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">16\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Exhaled-gas oesophageal intubation detector\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">17\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Fetal pulse oximeter\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">18\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Gas pipeline\/supply system air compressor\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">19\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Heated respiratory humidifier\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">20\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Home-use sleep apnoea recording system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">21\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Hyperbaric chamber\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">22\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Hypopnea sensor\/alarm\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">23\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Impedance pneumography recording\/analysis system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">24\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Implantable sleep apnoea treatment system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">25\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Infant apnoea monitor\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">26\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Manual chest percussor\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">27\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Nitrogen monoxide analyzer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">28\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Nitrous oxide analyzer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">29\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Pulse oximetry telemetric monitoring system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">30\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Respiratory apnoea monitoring system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">31\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Steam inhaler\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">32\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Stress test treadmill\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">33\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Therapeutic air ionizer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">34\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Therapeutic positive pressure breathing ventilator\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">35\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">The thoracic conductance measurement system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">36\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Thoracic electrical impedance segmentography system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">37\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">The thoracic electrical impedance tomography system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">38\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Thoracic suction pump\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">39\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Tongue-adjustment sleep apnoea treatment system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">40\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Tracheostoma protective filter\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">41\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Tracheostoma protector\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">42\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Tracheostomy tube lubricant\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">43\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Transcutaneous blood gas monitoring system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">44\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Valsalva maneuver mouthpiece\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">45\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Video intubation laryngoscope handle\/monitor\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">46\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Whole-body plethysmograph\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">47\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Diagnostic Spirometer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">48\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Monitoring Spirometer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">49\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Oxygen Concentrator\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">50\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">The pulmonary function analysis system\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">51\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Public respirator (2-ply, 3-ply face mask)\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fadcc8b e-flex e-con-boxed e-con e-parent\" data-id=\"fadcc8b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bef2b9e elementor-widget elementor-widget-heading\" data-id=\"bef2b9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Forms Required for Respiratory Registration in India: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8a744a elementor-widget elementor-widget-text-editor\" data-id=\"d8a744a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><span style=\"font-weight: 400;\">Applicant type\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Class\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Application\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">License\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Fees\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Manufacturer\u00a0<\/span><\/p><\/td><td rowspan=\"3\"><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Class A and B\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD-3\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD- 5\u00a0<\/span><\/p><\/td><td rowspan=\"2\"><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">For one site INR 5000 and INR 500 for a medical device\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Manufacturer (Loan License)\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD- 4\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD- 6\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Importer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD- 14\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Form MD- 15\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">$1000 for one site and $50 for one medical device unit\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a4e78d3 e-flex e-con-boxed e-con e-parent\" data-id=\"a4e78d3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8081dd0 elementor-widget elementor-widget-heading\" data-id=\"8081dd0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documents Required for CLASS A Respiratory Medical Device as per Medical Device Regulatory Affairs Body: <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff440fb elementor-widget elementor-widget-text-editor\" data-id=\"ff440fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h6><span style=\"font-weight: 400;\">For Manufacturer\u00a0<\/span><\/h6><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cover letter\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Site ownership details\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Description of the device, the proposed use of the device, specifications, and accessories\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The material used in construction;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Working principle and use of a novel technology (if any);\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Wherever applicable labels, package inserts (IFU, etc.), user manual,\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Summary of any Serious Adverse Event reported in India or in any of the countries where the device is marketed and what actions did National Regulatory Authority take;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Site or plant master file;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Constitution details of the firm (of the domestic manufacturer or authorized agent);\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Essential principles checklist for demonstrating conformity;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Undertaking signed by the manufacturer stating that the manufacturing site complies with the provisions of the Fifth Schedule;\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a06fc49 e-flex e-con-boxed e-con e-parent\" data-id=\"a06fc49\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8d7f277 elementor-widget elementor-widget-heading\" data-id=\"8d7f277\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documents Required for CLASS B Respiratory Medical Device as per Medical Device Regulatory Affairs Body: <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04f45fd elementor-widget elementor-widget-text-editor\" data-id=\"04f45fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h6><span style=\"font-weight: 400;\">For Manufacturer\u00a0<\/span><\/h6><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cover letter\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device master file\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Constitution details of the firm (of the domestic manufacturer or authorized agent);\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Essential principles checklist for demonstrating conformity;\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Test license (for the local manufacturer) (if any);\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Undertaking signed by the manufacturer stating that the manufacturing site complies with the provisions of the Fifth Schedule;\u00a0<br \/><br \/><\/span><\/li><\/ul><p><i><span style=\"font-weight: 400;\">Along with the documents as the mentioned above-authorized agent needs to submit a few more documents for the import license for both Class A and B respiratory medical devices:<\/span><\/i><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Notarized copy of overseas manufacturing site\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Free Sale Certificate issued by the National Regulatory Authority\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A Notarized copy of the Quality Management System certificate issued by the regulatory body.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Self-attested copy of valid wholesale license or manufacturing\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Copy of audit either latest or carried with last three years.\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d8d6ab9 e-flex e-con-boxed e-con e-parent\" data-id=\"d8d6ab9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3027de9 elementor-widget elementor-widget-heading\" data-id=\"3027de9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Can Operon Strategist Help You?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0bd134 elementor-widget elementor-widget-text-editor\" data-id=\"b0bd134\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div class=\"relative basis-auto flex-col -mb-(--composer-overlap-px) pb-(--composer-overlap-px) [--composer-overlap-px:28px] grow flex\"><div class=\"flex flex-col text-sm\"><div class=\"qMYqUG_convSearchResultHighlightRoot\"><div class=\"\" data-turn-id-container=\"request-WEB:e0f6556e-8a60-4c1b-8b1d-2ed042ea398b-2\" data-is-intersecting=\"true\"><section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-WEB:e0f6556e-8a60-4c1b-8b1d-2ed042ea398b-2\" data-turn-id-container=\"request-WEB:e0f6556e-8a60-4c1b-8b1d-2ed042ea398b-2\" data-testid=\"conversation-turn-6\" data-scroll-anchor=\"false\" data-turn=\"assistant\"><div class=\"text-base my-auto mx-auto pb-10 [--thread-content-margin:var(--thread-content-margin-xs,calc(var(--spacing)*4))] @w-sm\/main:[--thread-content-margin:var(--thread-content-margin-sm,calc(var(--spacing)*6))] @w-lg\/main:[--thread-content-margin:var(--thread-content-margin-lg,calc(var(--spacing)*16))] px-(--thread-content-margin)\"><div class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\"><div class=\"flex max-w-full flex-col gap-4 grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" dir=\"auto\" tabindex=\"0\" data-message-author-role=\"assistant\" data-message-id=\"37e54467-31c4-4373-9651-753503d3321a\" data-message-model-slug=\"gpt-5-5\" data-turn-start-message=\"true\"><div class=\"flex w-full flex-col gap-1 empty:hidden\"><div class=\"markdown prose dark:prose-invert wrap-break-word w-full light markdown-new-styling\"><p data-start=\"40\" data-end=\"889\" data-is-last-node=\"\" data-is-only-node=\"\"><span class=\"\" data-state=\"closed\"><a class=\"decorated-link\" href=\"https:\/\/operonstrategist.com?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\">Operon Strategist<\/a><\/span> helps manufacturers, importers, and distributors navigate the complete <a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\">CDSCO registration<\/a> process for respiratory medical devices in India. Our team provides end-to-end regulatory support, including device classification, documentation preparation, <a href=\"https:\/\/operonstrategist.com\/types-of-dmfs-and-the-importance-of-fdas-clarity-on-dmf-type-iii\/\">Device Master File<\/a> (DMF) preparation, application filing, import license assistance, and compliance with Medical Device Rules (MDR), 2017. We also assist businesses in preparing technical documents, essential principles checklists, quality management system documentation, and regulatory submissions to reduce delays and ensure faster approvals. With more than 12 years of experience in medical device regulatory consulting, Operon Strategist supports both domestic and international companies in achieving smooth market entry and regulatory compliance in India.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a847651 e-con-full e-flex e-con e-child\" data-id=\"3a847651\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2dfe209c elementor-widget elementor-widget-heading\" data-id=\"2dfe209c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-779291ea elementor-widget elementor-widget-n-accordion\" data-id=\"779291ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2000\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2000\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is CDSCO registration for respiratory medical devices? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2000\" class=\"elementor-element elementor-element-7c81e21d e-con-full e-flex e-con e-child\" data-id=\"7c81e21d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4e4f17a9 elementor-widget elementor-widget-text-editor\" data-id=\"4e4f17a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"126\" data-end=\"348\">CDSCO registration is the regulatory approval process required for manufacturers and importers who want to sell respiratory medical devices in India. The registration is governed under the Medical Device Rules (MDR), 2017.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2001\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2001\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are respiratory medical devices? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2001\" class=\"elementor-element elementor-element-233fa930 e-con-full e-flex e-con e-child\" data-id=\"233fa930\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d042370 elementor-widget elementor-widget-text-editor\" data-id=\"2d042370\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"819\" data-end=\"1087\">Respiratory medical devices are medical devices used to assist breathing, monitor respiratory conditions, or clear airway obstructions such as mucus, blood, or saliva. Examples include oxygen concentrators, spirometers, ventilators, and sleep apnea monitoring systems.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2002\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2002\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are the risk classes for respiratory medical devices in India? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2002\" class=\"elementor-element elementor-element-b9a9be5 e-con-full e-flex e-con e-child\" data-id=\"b9a9be5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-717eb02c elementor-widget elementor-widget-text-editor\" data-id=\"717eb02c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1161\" data-end=\"1240\">Respiratory medical devices are classified into four categories under MDR 2017:<\/p><ul data-start=\"1241\" data-end=\"1350\"><li data-section-id=\"11u2p6l\" data-start=\"1241\" data-end=\"1261\">Class A &#8211; Low risk<\/li><li data-section-id=\"m7z744\" data-start=\"1262\" data-end=\"1294\">Class B &#8211; Low to moderate risk<\/li><li data-section-id=\"1oheihr\" data-start=\"1295\" data-end=\"1328\">Class C &#8211; Moderate to high risk<\/li><li data-section-id=\"1sztsqq\" data-start=\"1329\" data-end=\"1350\">Class D &#8211; High risk<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2003\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2003\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which respiratory medical devices fall under Class A? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2003\" class=\"elementor-element elementor-element-527d0b7d e-con-full e-flex e-con e-child\" data-id=\"527d0b7d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d957d94 elementor-widget elementor-widget-text-editor\" data-id=\"d957d94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1613\" data-end=\"1674\">Some examples of Class A respiratory medical devices include:<\/p><ul data-start=\"1675\" data-end=\"1809\"><li data-section-id=\"tw2rwz\" data-start=\"1675\" data-end=\"1690\">Steam inhaler<\/li><li data-section-id=\"o88eeh\" data-start=\"1691\" data-end=\"1711\">Dry powder inhaler<\/li><li data-section-id=\"1adwcy4\" data-start=\"1712\" data-end=\"1735\">Stress test treadmill<\/li><li data-section-id=\"1icdnb0\" data-start=\"1736\" data-end=\"1760\">Tracheostoma protector<\/li><li data-section-id=\"mjmzvn\" data-start=\"1761\" data-end=\"1809\">Public respirator (2-ply and 3-ply face masks)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is CDSCO registration for respiratory medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"CDSCO registration is the regulatory approval process required for manufacturers and importers who want to sell respiratory medical devices in India. The registration is governed under the Medical Device Rules (MDR), 2017.\"}},{\"@type\":\"Question\",\"name\":\"What are respiratory medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Respiratory medical devices are medical devices used to assist breathing, monitor respiratory conditions, or clear airway obstructions such as mucus, blood, or saliva. 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The main aim of the CDSCO is to register the manufacturer and importers who want to sell and distribute medical devices in India in accordance with medical device regulatory affairs. On 6th Aug 2021, under [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6628,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6609","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6609","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/comments?post=6609"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6609\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/6628"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=6609"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=6609"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=6609"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}