{"id":48171,"date":"2022-09-03T17:47:43","date_gmt":"2022-09-03T12:17:43","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48171"},"modified":"2022-09-03T17:47:45","modified_gmt":"2022-09-03T12:17:45","slug":"cdsco-medical-device-registration-for-nebuliser","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-nebuliser\/","title":{"rendered":"CDSCO Medical Device Registration for Nebuliser \u2013 An Overview"},"content":{"rendered":"\n<p>The <strong>Central Drug Standard Control Organization (CDSCO)<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Central_Drugs_Standard_Control_Organisation\"><strong>[1]<\/strong><\/a><\/sup>, which serves as India&#8217;s National Regulatory Authority (NRA), oversees all the medical devices sold in the country. The Drug Controller General of India (DCGI) is in charge of CDSCO. The Directorate General of Health Services, under the Ministry of Health and Family Welfare, is in charge of CDSCO. The Drugs and Cosmetics Act governs the approval of drugs, establishes their standards, verifies the quality control of imported drugs, conducts clinical trials, etc. supervises all the medical devices in India. The Ministry of Consumer Affairs had made a proposal to mandate the CDSCO Medical Device Registration for Nebuliser under Medical Device Rules, 2017, along with other standards set by the Bureau of Indian Standards. With effect from January 1 2021, All the Nebulisers fall under the category of mandatory Registration of CDSCO Medical Devices. <\/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-medical-device-registration-for-nebuliser\/#Medical_Device_Regulation_in_India\" >Medical Device Regulation in\nIndia<\/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-medical-device-registration-for-nebuliser\/#Types_of_Nebuliser\" >Types of Nebuliser<\/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-medical-device-registration-for-nebuliser\/#Risk-wise_Classification_of_Medical_Devices\" >Risk-wise Classification of\nMedical 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-medical-device-registration-for-nebuliser\/#Necessary_Documents_for_CDSCO_Medical_Device_Registration_for_Nebuliser\" >Necessary Documents for CDSCO\nMedical Device Registration for Nebuliser<\/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-medical-device-registration-for-nebuliser\/#Procedure_for_CDSCO_Medical_Device_Registration_for_Nebuliser_in_India\" >Procedure for CDSCO Medical\nDevice Registration for Nebuliser in India<\/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-medical-device-registration-for-nebuliser\/#Timeline_for_CDSCO_Medical_Device_Registration_for_Nebuliser\" >Timeline for CDSCO Medical\nDevice Registration for Nebuliser<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-nebuliser\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Regulation_in_India\"><\/span>Medical Device Regulation in\nIndia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, the\nmarket for medical devices is a significant and vital component of the\nhealthcare industry, especially for the purpose of preventing, diagnosing,\ntreating, and managing severe ailments, impairments, diseases, and illnesses.\nIt is an important component of the healthcare system and aids in carrying out\nimportant functions laid down by the National Health Policy (NHP), 2017. It is\nalso essential for providing high-quality, affordable, and all-inclusive\nhealthcare services in India.<\/p>\n\n\n\n<p>According to Notification\n648 (E) issued by the Directorate General of Health Services and published in\nThe Official Gazette of India, It was announced that starting from April 1,\n2020, the following medical devices would be classified as drugs:<\/p>\n\n\n\n<p><em>&#8220;<\/em>All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either separately\/in combination with other devices, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one\/more specific purpose of-&#8221; <\/p>\n\n\n\n<ol><li>Diagnosis, monitoring,\u00a0 prevention, alleviation or treatment of any disorder or disease <\/li><li>Diagnosis, monitoring, treatment or alleviation of any disability or Injury <\/li><li>Replacement, investigation, support or modification of a physiological process or of the anatomy<\/li><li>Life support and sustaining <\/li><li>Medical Device disinfection<\/li><li>Conception control<\/li><\/ol>\n\n\n\n<p>A nebuliser is a<a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong> medical device<\/strong><\/a> that helps you to breathe in medicine as a fine mist through a mask or a mouthpiece. CDSCO Medical Device Registration for nebulisers is mandatory as per MDR, 2017.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Nebuliser\"><\/span>Types of Nebuliser<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A Nebuliser is a\nClass C medical device used for the purpose of inhaling medication for\nrespiratory disorders. The device delivers the medicine into the respiratory\nsystem and helps in stabilising breath and related issues. It is usually\nprescribed for the treatment of chronic pulmonary obstructive disease. The\nnebulisers are of the following types-<\/p>\n\n\n\n<ul><li>Gas Nebuliser<\/li><li>Heated Nebuliser <\/li><li>Venturi Nebuliser <\/li><li>Ultrasonic Nebuliser <\/li><li>Refillable Nebuliser <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk-wise_Classification_of_Medical_Devices\"><\/span>Risk-wise Classification of\nMedical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Nebuliser is\nclassified as a Class C medical device as per the Risk-based classification of\nthe Medical Device Rules, 2017. There are different classifications of medical\ndevices according to the level of risk involved with them. The DCGI regulates\nand controls medical devices as per medical device rules, 2017. The risk-wise\nclassification is divided into Class A medical devices, Class B medical\ndevices, Class C medical devices and Class D medical devices. The level of risk\nincreases from Class A to Class D. The risk-wise classification of medical\ndevices is listed below-<\/p>\n\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Device Class<\/strong>\n  <\/td><td>\n  <strong>Risk\n  Involved<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class A<\/strong>\n  <\/td><td>\n  Low level risk&nbsp; \n  <\/td><\/tr><tr><td>\n  <strong>Class B<\/strong>\n  <\/td><td>\n  Low-moderate level\n  risk\n  <\/td><\/tr><tr><td>\n  <strong>Class C<\/strong>\n  <\/td><td>\n  Moderate-High level risk\n  <\/td><\/tr><tr><td>\n  <strong>Class D <\/strong>\n  <\/td><td>\n  High level risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Necessary_Documents_for_CDSCO_Medical_Device_Registration_for_Nebuliser\"><\/span>Necessary Documents for CDSCO\nMedical Device Registration for Nebuliser<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents\nrequired for registration of Nebuliser as a CDSCO medical device are-<\/p>\n\n\n\n<ul><li>Application form (Form 40)<\/li><li>TR6 Challan<\/li><li>ISO 13485 Certificate <\/li><li>Power of attorney<\/li><li>The undertaking of authentic details<\/li><li>CE design certificate <\/li><li>Full quality assurance certificate <\/li><li>Declaration of conformity<\/li><li>Schedule D(I)<\/li><li>Device Master File<\/li><li>Plant Master File<\/li><li>Free Sale Certificate<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Medical_Device_Registration_for_Nebuliser_in_India\"><\/span>Procedure for CDSCO Medical\nDevice Registration for Nebuliser in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical devices\nwere not regulated by any authority in India earlier. They were sold in the\nIndian market without any regulation. After the year 2006, the government made\na rule that medical devices are required to be in compliance with the rules of\nCDSCO. The compliances needed mandatory requirement of registration of medical\ndevices with CDSCO before entering the market in India. The process of CDSCO\nMedical Device Registration for Nebuliser is as follows-<\/p>\n\n\n\n<ol><li><strong>Determine\nwhether the Medical Devices require registration or not:<\/strong> The first step is\nto check with the Medical Devices and IVDs list to check if the medical device\nis notified or not. All the notified medical devices are required to obtain\nregistration before they are marketed in India. In this case, the Nebuliser\nfalls under the category of notified devices and must be registered with CDSCO.&nbsp; <\/li><li><strong>Risk-Based\nClassification of Medical Devices:<\/strong> The notified devices which are required\nto be registered with CDSCO are then identified on the basis of risks involved\nwith them. The Nebuliser fall in Class C of risk-based categorisation of\nMedical Devices because they involve Medium-High level risk. <\/li><li><strong>Appointment\nof Indian Authorized Agent (IAA):<\/strong> An Indian Authorized Agent has been\nappointed in case the manufacturer is not an Indian. The IAA acts as a\nrepresentative on behalf of the manufacturer to conduct all his official duties\nin India. <\/li><li><strong>Technical\nDocumentation:<\/strong> All the necessary documents are required to be submitted to\nthe respective authorities in order to obtain a registration license.<\/li><li><strong>Obtain\nRegistration and License:<\/strong> After all the necessary documents are submitted\nto the correct authorities, the registration license is obtained by the\nmanufacturer. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Timeline_for_CDSCO_Medical_Device_Registration_for_Nebuliser\"><\/span>Timeline for CDSCO Medical\nDevice Registration for Nebuliser<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The time period\nof CDSCO Medical Device Registration for Nebuliser is 6 to 9 months after\ncompleting the application. The registration validity of the Medical Device is\nthree years. In order to renew the registration, the renewal application is\nrequired to be submitted before six months of expiry.<\/p>\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 nebuliser market In India comprises pneumatic nebulisers, ultra-sonic Nebuliser, mesh nebulisers, and nebuliser kits. By the end of 2023, the market of nebulisers in India is expected to reach INR. 703.4 million. Advanced technologies and the introduction of new products are the main reason for the market growth of medical devices in India. Since Nebulisers fall in the category of Class-C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for Nebuliser.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-defibrillators\/\">CDSCO Medical Device Registration for Defibrillators<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization (CDSCO)[1], which serves as India&#8217;s National Regulatory Authority (NRA), oversees all the medical devices sold in the country. The Drug Controller General of India (DCGI) is in charge of CDSCO. The Directorate General of Health Services, under the Ministry of Health and Family Welfare, is in charge of CDSCO. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48172,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2688],"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":4066,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48171"}],"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=48171"}],"version-history":[{"count":8,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48171\/revisions"}],"predecessor-version":[{"id":48180,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48171\/revisions\/48180"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48172"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48171"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48171"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}