{"id":49927,"date":"2022-10-12T11:40:06","date_gmt":"2022-10-12T06:10:06","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49927"},"modified":"2022-10-12T11:43:02","modified_gmt":"2022-10-12T06:13:02","slug":"cdsco-registration-for-respiratory-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-respiratory-medical-devices\/","title":{"rendered":"CDSCO Registration for Respiratory Medical Device- A complete analysis"},"content":{"rendered":"\n<p>Medical device safety, quality, and performance standards are governed by the Drugs and Cosmetics Act of 1940 and the rules promulgated thereunder. The Drugs Controller General of India under the Directorate General of Health Services notified on 6th August 2021, under the Medical Device Rules of 2017, regarding the <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration<\/strong><\/a> for Respiratory Medical Devices. Fifty-one medical devices with respiratory applications are classified as having been notified based on the intended use and risk-based classes.<\/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-respiratory-medical-devices\/#Overview_of_Medical_Device_Rules_2017\" >Overview of Medical Device Rules, 2017<\/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-respiratory-medical-devices\/#Classification_of_Non-Notified_Medical_devices_in_India\" >Classification of Non-Notified Medical devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-respiratory-medical-devices\/#Classification_for_Respiratory_Medical_Devices\" >Classification for Respiratory 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-respiratory-medical-devices\/#Documents_needed_for_CDSCO_Registration_for_Respiratory_Medical_Device\" >Documents needed for CDSCO Registration for Respiratory Medical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-respiratory-medical-devices\/#Procedure_for_CDSCO_Registration_for_Respiratory_Medical_Device\" >Procedure for CDSCO Registration for Respiratory Medical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-respiratory-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Medical_Device_Rules_2017\"><\/span>Overview of Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Central Drug Standard Control Organization is the national regulatory body of India. It is in charge of regulating various drugs and medical equipment in India. The Ministry of Health and Family Welfare oversees the CDSCO. The CDSCO is led by the Drug Controller General of India or <strong>DCGI<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\"><strong>[1]<\/strong><\/a><\/sup>. Before 2006, no official body in India regulated the sale of medical devices. As a result, consumers were exposed to various risks brought on by subpar devices and unchecked imports. CDSCO Registration for Respiratory Medical Devices is also regulated under it. <\/p>\n\n\n\n<p><strong>The duties carried out by CDSCO are:<\/strong><\/p>\n\n\n\n<ul><li>Registration of medical devices<\/li><li>Establishing guidelines for\ndrugs, IVDs, medical devices, etc.<\/li><li>Establishing legislation,\nrules, amendments, and regulations for drugs, medications, medical equipment,\nIVDs, etc.<\/li><li>Regulating the approval of\ndrugs and medical devices for sale.<\/li><li>Handling drug trials and clinical\nresearch in India.<\/li><li>Approval of a license to\nproduce specific drugs and other equipment related to medicine<\/li><li>Regulates the quality of drugs\nimported into India.<\/li><li>Drug testing at Central Drugs\nlaboratories.<\/li><\/ul>\n\n\n\n<p><strong>Risk-based classification of medical devices- <\/strong><\/p>\n\n\n\n<p>Medical devices and IVDs have been categorized into four classes by CDSCO based on the risk associated with them. Under the Medical device rules, 2017, \u00a0a medical device is categorized based on risk as follows:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  Classification of medical\n  devices\n  <\/td><td>\n  Risk association level\n  <\/td><\/tr><tr><td>\n  Class-A\n  <\/td><td>\n  Low risk \n  <\/td><\/tr><tr><td>\n  Class-B\n  <\/td><td>\n  Low-moderate risk \n  <\/td><\/tr><tr><td>\n  Class-C\n  <\/td><td>\n  Moderate- high risk\n  <\/td><\/tr><tr><td>\n  Class-D\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=\"Classification_of_Non-Notified_Medical_devices_in_India\"><\/span><strong>Classification of Non-Notified Medical devices in India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Notified medical\ndevices and Non-Notified medical devices are the categories into which medical\ndevices fall. Only notified medical devices were previously regulated in India,\nbut on CDSCO&#8217;s orders, non-notified medical devices were invited to voluntarily\nregister by a specific deadline. Even non-notified devices will be included in\nthe category of required registration by CDSCO once the deadline has passed.\nClass A and B medical devices must be voluntarily registered by 1st October\n2022, and Class C and D medical devices are to be registered by 1st October\n2023.<\/p>\n\n\n\n<p>CDSCO in India\npreviously regulated only 37 medical devices, but as the country&#8217;s medical\ndevice market grew, more unregulated medical devices were exposed to Indian\nconsumers, posing severe health risks. The Ministry of Health and Family\nWelfare recently invited voluntary registration of all unnotified medical\ndevices in a notification published on 11th February 2020.<\/p>\n\n\n\n<p>On 3rd September 2020, CDSCO published a new notice that included a list of 24 medical devices that had not yet been registered with CDSCO. The list also included CDSCO Registration for Respiratory Medical Devices. The list also included a variety of other medical devices, including medical devices for anaesthesia, pain management, cardiovascular health, etc. The list of those 24 newly listed devices is as follows:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  S.L. No.\n  <\/td><td>\n  Categories of medical device\n  <\/td><\/tr><tr><td>\n  1\n  <\/td><td>\n  Anaesthesiology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  2\n  <\/td><td>\n  Pain Management&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  3\n  <\/td><td>\n  Cardiovascular&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  4\n  <\/td><td>\n  Dental&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  5\n  <\/td><td>\n  Ear, Nose, Throat (ENT)&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  6\n  <\/td><td>\n  Gastroenterological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  7\n  <\/td><td>\n  Urological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  8\n  <\/td><td>\n  General Hospital&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  9\n  <\/td><td>\n  Operation Theater (O.T.)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  <strong>10<\/strong>\n  <\/td><td>\n  <strong>Respiratory&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>\n  <\/td><\/tr><tr><td>\n  11\n  <\/td><td>\n  Neurological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  12\n  <\/td><td>\n  Personnel use&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  13\n  <\/td><td>\n  Obstetrical and Gynaecological\n  (O.G.)\n  <\/td><\/tr><tr><td>\n  14\n  <\/td><td>\n  Ophthalmic&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  15\n  <\/td><td>\n  Rehabilitation&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  16\n  <\/td><td>\n  Physical support&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  17\n  <\/td><td>\n  Interventional and Radiology\n  <\/td><\/tr><tr><td>\n  18\n  <\/td><td>\n  Rheumatology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  19\n  <\/td><td>\n  Dermatology and Plastic Surgery\n  <\/td><\/tr><tr><td>\n  20\n  <\/td><td>\n  Paediatric and Neonatology\n  Medical\n  <\/td><\/tr><tr><td>\n  21\n  <\/td><td>\n  Oncology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  22\n  <\/td><td>\n  Radiotherapy&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  23\n  <\/td><td>\n  Nephrology and Renal care&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  24\n  <\/td><td>\n  Software&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_for_Respiratory_Medical_Devices\"><\/span>Classification for Respiratory Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The list includes CDSCO Registration for Respiratory Medical Devices and other devices. In total, 51 medical devices are categorized in the CDSCO Registration for Respiratory Medical Device list according to the intended use, which is as follows, per a notice released by CDSCO on 6th August 2021.<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Sr. No.<\/strong>\n  <\/td><td>\n  <strong>Medical Device Name <\/strong>\n  <\/td><td>\n  <strong>Risk Class <\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>1 <\/strong>\n  <\/td><td>\n  Activated-oxygen\n  generator \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>2 <\/strong>\n  <\/td><td>\n  Argon gas analyzer \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>3 <\/strong>\n  <\/td><td>\n  Artificial\n  airway tube cuff pressure monitor \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>4 <\/strong>\n  <\/td><td>\n  Bulk oxygen concentration system\n  \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>5 <\/strong>\n  <\/td><td>\n  Cardiopulmonary\n  resuscitation mask \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>6 <\/strong>\n  <\/td><td>\n  Cerebral oximeter \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>7 <\/strong>\n  <\/td><td>\n  Chest-oscillation\n  airway secretion-clearing system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>8 <\/strong>\n  <\/td><td>\n  Chest-percussion airway\n  secretion-clearing system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>9 <\/strong>\n  <\/td><td>\n  Cold-air\n  diagnostic inhalation system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>10 <\/strong>\n  <\/td><td>\n  Cough long-term ambulatory\n  recording system \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>11 <\/strong>\n  <\/td><td>\n  Cricothyrotomy \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>12 <\/strong>\n  <\/td><td>\n  Dry powder inhaler \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>13 <\/strong>\n  <\/td><td>\n  The dry salt\n  therapy device \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>14 <\/strong>\n  <\/td><td>\n  Electroacoustic airway\n  secretion-clearing system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>15 <\/strong>\n  <\/td><td>\n  Endotracheal\n  tube introducer \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>16<\/strong>\n  <\/td><td>\n  Exhaled-gas oesophageal\n  intubation detector \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>17 <\/strong>\n  <\/td><td>\n  Foetal pulse\n  oximeter \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>18 <\/strong>\n  <\/td><td>\n  Gas pipeline\/supply system air\n  compressor \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>19 <\/strong>\n  <\/td><td>\n  Heated\n  respiratory humidifier\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>20<\/strong>\n  <\/td><td>\n  Home-use sleep apnoea recording\n  system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>21 <\/strong>\n  <\/td><td>\n  Hyperbaric\n  chamber \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  <strong>22<\/strong>\n  <\/td><td>\n  Hypopnea sensor\/alarm \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>23 <\/strong>\n  <\/td><td>\n  Impedance\n  pneumography recording\/analysis system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>24 <\/strong>\n  <\/td><td>\n  Implantable sleep apnoea\n  treatment system\n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  <strong>25 <\/strong>\n  <\/td><td>\n  Infant apnoea\n  monitor\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>26 <\/strong>\n  <\/td><td>\n  Manual chest percussor \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>27 <\/strong>\n  <\/td><td>\n  Nitrogen\n  monoxide analyzer \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>28 <\/strong>\n  <\/td><td>\n  Nitrous oxide analyzer \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>29 <\/strong>\n  <\/td><td>\n  Pulse oximetry\n  telemetric monitoring system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>30 <\/strong>\n  <\/td><td>\n  Respiratory apnoea monitoring\n  system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>31 <\/strong>\n  <\/td><td>\n  Steam inhaler \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>32 <\/strong>\n  <\/td><td>\n  Stress test treadmill\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>33 <\/strong>\n  <\/td><td>\n  Therapeutic air\n  ionizer \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>34 <\/strong>\n  <\/td><td>\n  Therapeutic positive pressure\n  breathing ventilator \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  <strong>35 <\/strong>\n  <\/td><td>\n  The thoracic\n  conductance measurement system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>36<\/strong>\n  <\/td><td>\n  Thoracic electrical impedance\n  segmentography system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>37 <\/strong>\n  <\/td><td>\n  The thoracic\n  electrical impedance tomography system \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  <strong>38 <\/strong>\n  <\/td><td>\n  Thoracic suction pump \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>39 <\/strong>\n  <\/td><td>\n  Tongue-adjustment\n  sleep apnoea treatment system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>40 <\/strong>\n  <\/td><td>\n  Tracheostoma protective filter \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>41 <\/strong>\n  <\/td><td>\n  Tracheostoma\n  protector \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>42 <\/strong>\n  <\/td><td>\n  Tracheostomy tube lubricant \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>43 <\/strong>\n  <\/td><td>\n  Transcutaneous\n  blood gas monitoring system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>44 <\/strong>\n  <\/td><td>\n  Valsalva manoeuvre mouthpiece \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>45 <\/strong>\n  <\/td><td>\n  Video\n  intubation laryngoscope handle\/monitor \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  <strong>46 <\/strong>\n  <\/td><td>\n  Whole-body plethysmograph \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>47 <\/strong>\n  <\/td><td>\n  Diagnostic\n  Spirometer \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>48 <\/strong>\n  <\/td><td>\n  Monitoring Spirometer \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>49 <\/strong>\n  <\/td><td>\n  Oxygen\n  Concentrator\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>50 <\/strong>\n  <\/td><td>\n  Pulmonary function analysis\n  system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>51 <\/strong>\n  <\/td><td>\n  Public\n  respirator (2-ply, 3-ply face mask) \n  <\/td><td>\n  A\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_needed_for_CDSCO_Registration_for_Respiratory_Medical_Device\"><\/span>Documents needed for CDSCO Registration for Respiratory Medical Device <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nprerequisites for CDSCO Registration for Respiratory Medical Devices are as\nfollows:<\/p>\n\n\n\n<ul><li>Application form<\/li><li>TR6 Challan <\/li><li>ISO 13485<\/li><li>Power of Attorney<\/li><li>An undertaking confirming the\naccuracy of the information provided<\/li><li>Assurance of quality\ncertificate<\/li><li>Accreditation from C.E. Design<\/li><li>Statement of compliance<\/li><li>D Schedule (I)<\/li><li>Device master file<\/li><li>Plant master file<\/li><li>Free sale receipt<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_Respiratory_Medical_Device\"><\/span>Procedure for CDSCO Registration for Respiratory Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is a\nlist of the steps involved in CDSCO Registration for Respiratory Medical\nDevices in India. <\/p>\n\n\n\n<ol><li>The applicants must first check\nthe Medical Devices and IVDs list to see if a medical device has been notified\nor not. All non-notified medical devices must complete voluntary registration\nbefore the deadline to be marketed in India.<\/li><li>In cases where the manufacturer\nof the medical device is not an Indian, an Indian Authorized Agent is chosen on\nhis behalf. He is in charge of performing the manufacturer&#8217;s responsibilities.\nThe IAA conducts all of its official business in India and represents the\nmanufacturer in court.<\/li><li>To obtain a registration\nlicense, all necessary paperwork and documentation must be submitted to the\nrelevant authorities.<\/li><li>The manufacturer receives the\nlicense once the licensing authorities are satisfied with all the paperwork and\nother requirements.<\/li><\/ol>\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>To comply with the most recent medical device regulations in India, the Ministry of Health and Family Welfare has released a new risk-based Classification for CDSCO Registration for Respiratory Medical Devices. The notice was issued on 3rd September 2020, and it listed 24 medical devices as respiratory medical devices that CDSCO will classify as non-notified medical devices. Medical device registration can be a technical process; even a small error could result in significant time and financial losses. To avoid wasting time and money on a potential failure, getting in touch with an experienced professional for CDSCO Registration for Respiratory Medical Devices is always advisable.<\/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\/parameters-for-classification-of-ivd-medical-devices\/\">Parameters for Classification of IVD Medical Devices\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical device safety, quality, and performance standards are governed by the Drugs and Cosmetics Act of 1940 and the rules promulgated thereunder. The Drugs Controller General of India under the Directorate General of Health Services notified on 6th August 2021, under the Medical Device Rules of 2017, regarding the CDSCO Registration for Respiratory Medical Devices. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":49935,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2778],"acf":{"service_id":"508"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":3569,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49927"}],"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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=49927"}],"version-history":[{"count":19,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49927\/revisions"}],"predecessor-version":[{"id":49947,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49927\/revisions\/49947"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49935"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49927"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49927"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49927"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}