{"id":48220,"date":"2022-09-05T15:49:19","date_gmt":"2022-09-05T10:19:19","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48220"},"modified":"2022-09-05T15:49:20","modified_gmt":"2022-09-05T10:19:20","slug":"cdsco-medical-device-registration-for-bp-monitor","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-bp-monitor\/","title":{"rendered":"CDSCO Medical Device Registration for BP Monitor"},"content":{"rendered":"\n<p>The <strong>Central Drug Standard Control Organization<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Central_Drugs_Standard_Control_Organisation\"><strong>[1]<\/strong><\/a><\/sup> regulates the Indian medical device Industry under the provisions of the Drugs and Cosmetics Act and Rules. Every country, like India, has its own regulatory body to look after every aspect of medical devices and drugs related services. The CDSCO looks after the regulation and sales of notified medical devices in India, which regulates and governs the CDSCO. The Directorate General of Health Services comes under the Ministry of Health and Family Welfare, under the government of India. As Per the issued notification in the Medical Device Rules 2017, the CDSCO <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Device Registration<\/strong><\/a> for BP Monitor is mandatory before being marketed in India.<\/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-bp-monitor\/#About_BP_Monitor_Medical_Device\" >About BP Monitor Medical Device<\/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-bp-monitor\/#Medical_Device_Status_in_India\" >Medical Device Status 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-medical-device-registration-for-bp-monitor\/#Risk-Based_Classification_of_Medical_Devices\" >Risk-Based Classification of 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-medical-device-registration-for-bp-monitor\/#Checklist_for_CDSCO_Medical_Device_Registration_for_BP_Monitor\" >Checklist for CDSCO Medical Device Registration for BP Monitor<\/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-bp-monitor\/#Procedure_for_CDSCO_Medical_Device_Registration_for_BP_Monitor\" >Procedure for CDSCO Medical Device Registration\nfor BP Monitor<\/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-bp-monitor\/#Timeline_for_CDSCO_Medical_Device_Registration_for_BP_Monitor\" >Timeline for CDSCO Medical Device Registration for\nBP Monitor<\/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-bp-monitor\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"About_BP_Monitor_Medical_Device\"><\/span>About BP Monitor Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A Blood Pressure\n(BP) monitoring device is used to precisely check a person&#8217;s blood pressure. It\ncomprises a pump, an air pressure sensor, and an inflatable cuff. A controlled\ncollapse and release of the artery beneath the cuff occur when the cuff is\napplied to the user&#8217;s left arm. It is used to measure the amount of blood the\nheart pumps. Numerous inexpensive, lightweight, and portable blood pressure\nmonitors have been introduced to the market. They have an extensive reading\ndisplay and are simple to operate. These digital gadgets also can save a large\nnumber of earlier readings, which helps the users maintain track of their\naverage blood pressure. The market for Blood pressure monitors is expected to\nreach around 2.1 Billion US $in the year 2022, globally. The rise of chronic\ndiseases is the driving factor which increases the market growth of BP monitor\nmedical devices, and the government has mandated the CDSCO Medical Device\nRegistration for BP Monitor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Status_in_India\"><\/span>Medical Device Status in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to a\nnotification issued by CDSCO, four new medical devices- BP monitor, Nebuliser,\nDigital Thermometer, and Glucometer- are also considered drugs in India. The\nCentral Drug Standard Control Organization regulates all the drugs and medical\ndevices in India. The CDSCO published a notification stating the regulation of\nspecific medical devices as drugs from January 1st, 2021. In the light of the\nnotification number 648(E) published in the official gazette of India by the\nDirectorate General of Health Services, the following medical devices are\nconsidered as Drug from April 1st 2020-<\/p>\n\n\n\n<p>&#8220;All the\ndevices that are Instrument, appliance, implant, apparatus, or any other tool,\nwhich is used either separately or in combination with other device, accessory\nor software and Is used specifically for humans and animals, which do not\nachieve the primary intended action in or on animal or human body by any\npharmacological or Immunological or metabolic means, but which may help in its\nintended function by such means for one or more specific purpose of-&#8221; <\/p>\n\n\n\n<ol><li>Diagnosis, monitoring,&nbsp; prevention, alleviation or treatment of any\ndisorder or disease <\/li><li>Diagnosis, monitoring, treatment or alleviation\nof any disability or Injury <\/li><li>Replacement, investigation, support or\nmodification of a physiological process or the anatomy<\/li><li>Life support and sustaining <\/li><li>Medical Device disinfection<\/li><li>Conception control<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk-Based_Classification_of_Medical_Devices\"><\/span>Risk-Based Classification of Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>BP monitor\nmachine is a device used to measure diastolic and systolic blood pressures. It\nis classified as a Class B medical device because of its Low to Medium level\nrisk associated with the device.<\/p>\n\n\n\n<p>According to\nCDSCO, medical devices are classified into four classes based on the risk\ninvolved with their usage. The DCGI or the head of CDSCO regulates all the\nclasses of medical devices. However, licenses for Class A and Class B medical\ndevices are obtained from State Licensing Authority. In contrast, permits for\nClass C and Class D medical devices are obtained from Central Licensing\nAuthority or CDSCO. The government has also mandated the CDSCO Medical Device\nRegistration for BP Monitor.<\/p>\n\n\n\n<p><strong><em>The\nfollowing table lists the medical devices as per the risk involved with them-<\/em><\/strong><\/p>\n\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Medical Device Category<\/strong>\n  <\/td><td>\n  <strong>Risk Involved<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class-A <\/strong>\n  <\/td><td>\n  Low risk involved \n  <\/td><\/tr><tr><td>\n  <strong>Class-B<\/strong>\n  <\/td><td>\n  Low-Medium risk involved \n  <\/td><\/tr><tr><td>\n  <strong>Class-C <\/strong>\n  <\/td><td>\n  Medium-High risk involved \n  <\/td><\/tr><tr><td>\n  <strong>Class-D<\/strong>\n  <\/td><td>\n  High risk involved \n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>The degree of\nrisk increases with the increased class level of devices. Because of the\nLow-Medium risk involved, the BP monitor is categorized as Class-B medical\ndevice. Hence, any kind of license for BP monitor is to be obtained by the\nState Licensing Authority of India. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_for_CDSCO_Medical_Device_Registration_for_BP_Monitor\"><\/span><strong>Checklist for CDSCO Medical Device Registration for BP Monitor <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the\nchecklist for CDSCO Medical Device Registration for BP Monitor:<\/p>\n\n\n\n<ul><li>Application Form <\/li><li>ISO 13485 Certificate <\/li><li>TR6 Challan<\/li><li>Power of attorney<\/li><li>Undertaking that only authentic details are\n     provided <\/li><li>Full quality assurance certificate <\/li><li>CE Design certificate <\/li><li>Declaration of conformity<\/li><li>Schedule D(I) <\/li><li>Device master file <\/li><li>Plant master report <\/li><li>Free sale certificate&nbsp; <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Medical_Device_Registration_for_BP_Monitor\"><\/span>Procedure for CDSCO Medical Device Registration\nfor BP Monitor<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before 2006,\nMedical Devices in India were sold in the market without any regulations, and\nthere were no rules governing them. Later, CDSCO made a rule that all the\nmedical devices circulated in the market must comply with CDSCO. The\ncompliances made it compulsory for Medical Devices to be registered with CDSCO\nbefore manufacturing, selling or importing into the Indian market. Following\nare the steps to be followed for CDSCO Medical Device Registration for BP\nmonitor in India- <\/p>\n\n\n\n<ol><li><strong>Determine\nwhether the Medical Devices require registration:<\/strong> Firstly, the applicant\nmust check whether the Medical Devices and IVDs list to check whether the\nmedical device is notified or not. All the medical devices that are notified\nmust obtain registration before they are marketed in India. In this case, the\nBP monitor machine falls under the category of notified devices and must be\nregistered 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 based on the risks involved\nwith them. The BP Monitor falls in Class B of risk-based categorization of\nMedical Devices because they involve Medium level risk.<\/li><li><strong>Appointment\nof Indian Authorized Agent:<\/strong> An IAA or Indian Authorized Agent has been\nappointed in case the manufacturer is not an Indian. The IAA is the legal\nrepresentative of the manufacturer and performs all its official duties in\nIndia.<\/li><li><strong>Documentation\nProcess:<\/strong> All the necessary documents are required to be submitted to the\nrespective authorities to get a registration license.<\/li><li><strong>Receiving\nof Registration and License:<\/strong> After submitting all the necessary documents\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_BP_Monitor\"><\/span>Timeline for CDSCO Medical Device Registration for\nBP Monitor<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Time taken to\ncomplete the CDSCO Medical Device Registration for BP Monitor is six to nine\nmonths after completing the application. The validity of registration remains\nvalid for three years. In case the registration needs to be renewed, the\napplication for renewal must be submitted six months from the expiry date. <\/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 market for Blood pressure monitors is expected to reach around 2.1 Billion US$ in the year 2022, globally. The blood pressure monitor market is, however, restrained by the high cost of advanced devices. However, there has been significant market growth in medical devices. Since BP Monitor falls in the category of Class-B Medical devices, and the registration becomes valid. Even an error in the registration process may lead to the rejection of the application. Hence, it is always advisable to get professional help for CDSCO Medical Device for BP Monitor registration.<\/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-organ-preservation-solution\/\">How to Obtain CDSCO Medical Device Registration for Organ Preservation Solution in India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization[1] regulates the Indian medical device Industry under the provisions of the Drugs and Cosmetics Act and Rules. Every country, like India, has its own regulatory body to look after every aspect of medical devices and drugs related services. The CDSCO looks after the regulation and sales of notified medical [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48226,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2693],"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":5812,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48220"}],"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=48220"}],"version-history":[{"count":11,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48220\/revisions"}],"predecessor-version":[{"id":48238,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48220\/revisions\/48238"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48226"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48220"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48220"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48220"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}