{"id":47902,"date":"2022-09-01T10:39:00","date_gmt":"2022-09-01T05:09:00","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47902"},"modified":"2022-09-01T16:30:26","modified_gmt":"2022-09-01T11:00:26","slug":"cdsco-medical-device-registration-for-bone-marrow-cell-separator","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-bone-marrow-cell-separator\/","title":{"rendered":"How to Obtain CDSCO Medical Device Registration for Bone Marrow Cell Separator?"},"content":{"rendered":"\n<p>On April 18, 2021, the Central Drugs Standard Control Organization (CDSCO) issued an order regulating Bone marrow cell separator equipment, all implanted devices, MRI equipment, and other medical devices as drugs, effective as of April 1, 2021. According to Order No. S.O. 775(E), dated February 8, 2019, the importer or manufacturer of such devices must obtain an import or manufacturing licence from the Central Licensing Authority. These devices include all implantable medical devices such as C.T. scan equipment, MRI equipment, Defibrillators, PET equipment, Dialysis machines, X-ray machines, and bone marrow cell separators. As a result, if a current importer or manufacturer of one of the devices mentioned earlier applies for a licence under the MDR of 2017, the application will be accepted, and the importer or manufacturer may continue to import or manufacture such devices. This write-up will discuss CDSCO Medical Device Registration for Bone Marrow Cell Separator.<\/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-bone-marrow-cell-separator\/#Brief_of_Drugs_Cosmetics_Act_1940\" >Brief of Drugs &amp; Cosmetics Act, 1940<\/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-bone-marrow-cell-separator\/#What_is_a_Bone_Marrow_Cell_Separator\" >What is a Bone Marrow Cell\nSeparator?<\/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-bone-marrow-cell-separator\/#Regulatory_Bodies_for_the_CDSCO_Medical_Device_Registration_in_India\" >Regulatory Bodies for the CDSCO\nMedical Device Registration in India<\/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-bone-marrow-cell-separator\/#Classification_of_Medical_Devices\" >Classification of Medical\nDevices<\/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-bone-marrow-cell-separator\/#Risk_Based_Classifications_for_Medical_Devices_Equipment_under_CDSCO\" >Risk Based Classifications for\nMedical Devices &amp; Equipment under CDSCO<\/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-bone-marrow-cell-separator\/#Documents_Required_for_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\" >Documents Required for CDSCO\nMedical Device Registration for Bone Marrow Cell Separator<\/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-bone-marrow-cell-separator\/#Procedure_to_Obtain_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\" >Procedure to Obtain CDSCO\nMedical Device Registration for Bone Marrow Cell Separator<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-bone-marrow-cell-separator\/#Time_Taken_for_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\" >Time Taken for CDSCO Medical\nDevice Registration for Bone Marrow Cell Separator<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-bone-marrow-cell-separator\/#Renewal_of_the_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\" >Renewal of the CDSCO Medical\nDevice Registration for Bone Marrow Cell Separator<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-bone-marrow-cell-separator\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Brief_of_Drugs_Cosmetics_Act_1940\"><\/span>Brief of Drugs &amp; Cosmetics Act, 1940<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drugs &amp; Cosmetics Act of 1940 is an Act introduced by the Parliament of India that regulates the manufacture, import, or distribution of drugs in the country. The Act&#8217;s primary goal is to ensure that drugs &amp; cosmetics sold in India are effective, safe and meet quality standards. The associated <strong><em>Drugs &amp; Cosmetics Rules, 1945<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Rules,_1945\"><strong>[1]<\/strong><\/a><\/sup>, provide provisions for categorizing drugs into schedules and guidelines for storing, displaying, selling, and prescribing all categories.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_a_Bone_Marrow_Cell_Separator\"><\/span>What is a Bone Marrow Cell\nSeparator?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the case of\ndiseases such as bone marrow disease or leukaemia,&nbsp;the bone marrow\nmakes abnormal white blood cells. A bone marrow cell separator is required to\ndetect the disease or its intensity,. It is a general laboratory medical device\nto isolate target cells and cells concentrated through bone &amp; blood. Bone\nmarrow samples can be obtained through aspiration &amp; trephine biopsy. It is\nlisted under the Class B medical device category depending on the risk type.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_Bodies_for_the_CDSCO_Medical_Device_Registration_in_India\"><\/span>Regulatory Bodies for the CDSCO\nMedical Device Registration in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong>CDSCO\n(Central Drugs Standards Control Organization):<\/strong> It is the head regulatory\nbody in India, under the DGHS (Directorate General of Health Services) and\nMinistry of Health &amp; Family Welfare, which regulates pharmaceuticals &amp; medical\ndevices.<\/li><li><strong>The Drugs &amp; Cosmetic Act\nand Rules:&nbsp;<\/strong>These rules regulate the Manufacture,\nImport, and Distribution of Drugs in India.<\/li><li><strong>DCGI:&nbsp;<\/strong>It&#8217;s the\nhead of CDSCO and is answerable for the approval of quality drugs &amp; cosmetics\nto be sold in India and for regulating clinical trials.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices\"><\/span>Classification of Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical devices under CDSCO have been classified into two categories, as mentioned below:<\/p>\n\n\n\n<ul><li><strong>Notified Medical Devices<\/strong><\/li><\/ul>\n\n\n\n<ol><li>According to Rule 4 of Medical Devices Rule 2017, notified medical devices are those whose certification is compulsory.<\/li><li>Notified medical devices comprise a total of 37 items which compulsory need to be CDSCO Certified.<\/li><\/ol>\n\n\n\n<ul><li><strong>Non\u2013Notified Medical Devices<\/strong><\/li><\/ul>\n\n\n\n<ol><li>According to the new amendment issued through CDSCO, devices like instruments, implants and apparatus, irrespective of their usage for the distinct objective, will fall under non-notified medical devices.<\/li><li>Non &#8211; Notified medical devices include 313 products, which must be CDSCO Certified.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk_Based_Classifications_for_Medical_Devices_Equipment_under_CDSCO\"><\/span>Risk Based Classifications for\nMedical Devices &amp; Equipment under CDSCO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical Devices\n&amp; Equipment under CDSCO are generally based on the risk, medical devices&#8217;\nintended objective and use, and accurate risk-based analysis. The medical\ndevices &amp; equipment under the CDSCO Classification have a large group of\ndevices, such as cannulas &amp; stents, in specific subgroups;<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Risk Category<\/strong>\n  <\/td><td>\n  <strong>Examples of\n  Medical Devices <\/strong>\n  <\/td><\/tr><tr><td>\n  Low (Class A)\n  <\/td><td>\n  Surgical dressings,\n  Syringes, etc.\n  <\/td><\/tr><tr><td>\n  Low Moderate (Class B)\n  <\/td><td>\n  Surgical gloves,\n  pregnancy Kits, etc.\n  <\/td><\/tr><tr><td>\n  Moderate-High (Class C)\n  <\/td><td>\n  Lung Ventilators,\n  Anaesthesia, etc. \n  <\/td><\/tr><tr><td>\n  High (Class D)\n  <\/td><td>\n  Heart &amp; Lung Bypass Unit, Pacemakers, Implants,\n  etc\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\"><\/span>Documents Required for CDSCO\nMedical Device Registration for Bone Marrow Cell Separator <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some essential documents required for getting CDSCO Medical Device Registration for Bone Marrow Cell Separator:<\/p>\n\n\n\n<ul><li>Form 40 under the proforma prescribed in the Drugs &amp; Cosmetics Rules;<\/li><li>ISO 24651: 2022 Certificate;<\/li><li>Legal manufacturer&#8217;s name &amp; address with phone no. email id; <\/li><li>C.E. Design Certificate;<\/li><li>Actual Site Information;<\/li><li>Full Quality Assurance Certificate;<\/li><li>Nature of activity (import or export)<\/li><li>Undertaking that all the information provided is authentic;<\/li><li>Band Name (if registered under the Trade Marks Act, 1999);<\/li><li>Certificate of Marketability from GHTF (the United States, the European Union, Japan, Australia, Canada)<\/li><li>Free Sale Certificate (FSC) or Certificate from the Foreign Government;<\/li><li>Device Master File;<\/li><li>Plant Master Report.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\"><\/span>Procedure to Obtain CDSCO\nMedical Device Registration for Bone Marrow Cell Separator<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO Registration is an entirely online process. Following is the process for obtaining CDSCO Medical Device Registration for Bone Marrow Cell Separator:<\/p>\n\n\n\n<p><strong>Step 1:<\/strong> The applicant has to visit the\nCDSCO (Sugam Portal);<\/p>\n\n\n\n<p><strong>Step 2:<\/strong> The applicant needs to apply for <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration<\/strong><\/a>; for that, the applicant needs to go to the CDSCO Registration purpose page and click on submit.<\/p>\n\n\n\n<p><strong>Step 3:<\/strong> After the applicant opens the\nCDSCO Registration page, the applicant must fill in all the vital information\nprovided in the application form.<\/p>\n\n\n\n<p><strong>Step 4:<\/strong> Fill out the Registered Indian\nAddress Form containing details.<\/p>\n\n\n\n<p><strong>Step 5:<\/strong> After the applicant submits the\napplication form correctly, the applicant will get a confirmation link to their\nregistered email id to verify the Medical Device Registration. Then the\napplicant must click on the link to activate the applicant account on the CDSCO\nSugam Portal.<\/p>\n\n\n\n<p><strong>Step 6: <\/strong>After the confirmation link is\nclicked, the application form for Registration will be submitted to the\nauthorized department for approval.<\/p>\n\n\n\n<p><strong>Step 7:<\/strong> After the application form for\nRegistration is approved, an approved email will send to the applicant&#8217;s\nregistered email id. If the application form is rejected, an email for\nrejection will be sent to the applicant&#8217;s email id. After the applicant gets\nthe approval email, CDSCO Medical Device Registration will be completed.<\/p>\n\n\n\n<p><strong><em>Note:\nAfter getting the CDSCO Registration Certificate, it shall be valid for three years\nfrom the date of issue of the Registration Certificate unless cancelled or\nsuspended by the DGCI authority. <\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Time_Taken_for_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\"><\/span>Time Taken for CDSCO Medical\nDevice Registration for Bone Marrow Cell Separator<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It takes almost\n6 to 9 months to register a medical device. Unless there&#8217;s an examination required\nthrough Technical Presentation or Subject Expert Committee (SEC), if these are\nnecessary, then the registration process is extended by an additional 3 to 6\nmonths. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Renewal_of_the_CDSCO_Medical_Device_Registration_for_Bone_Marrow_Cell_Separator\"><\/span>Renewal of the CDSCO Medical\nDevice Registration for Bone Marrow Cell Separator<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The application\nfor renewal of the Medical Device Registration certificate shall be made at\nleast 9 months before the expiry of the Registration. Though there are no\nadditional requirements for the renewal process, it shall be essential for the\nRegistration Certificate holder to provide a copy of the DMF (Device Master\nFile) and PMF (Plant Master File), where there is no change in the DMF and PMF.<\/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>India&#8217;s medical device market is anticipated to grow over the coming years due to rising health awareness, the middle class, and government health initiatives. The Indian government published the Medical Device Rules in 2017 to alter how medical devices are governed. The CDSCO (Central Drugs Standard Control Organization), a Ministry of Health and Family Welfare division, ensures that machines abide by the regulations, which came into force in January 2018.  <\/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-registration-certificate-for-ct-scan-machine\/\">An Overview of CDSCO Registration Certificate for CT Scan Machine<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On April 18, 2021, the Central Drugs Standard Control Organization (CDSCO) issued an order regulating Bone marrow cell separator equipment, all implanted devices, MRI equipment, and other medical devices as drugs, effective as of April 1, 2021. According to Order No. S.O. 775(E), dated February 8, 2019, the importer or manufacturer of such devices must [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":47903,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2667],"acf":{"service_id":"508"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":2598,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47902"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=47902"}],"version-history":[{"count":9,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47902\/revisions"}],"predecessor-version":[{"id":47979,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47902\/revisions\/47979"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47903"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}