{"id":11698,"date":"2022-08-27T09:23:24","date_gmt":"2022-08-27T09:23:24","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=11698"},"modified":"2022-08-27T09:34:42","modified_gmt":"2022-08-27T09:34:42","slug":"manufacturing-registration-for-cdsco-medical-devices","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/","title":{"rendered":"Manufacturing Registration for CDSCO Medical Devices"},"content":{"rendered":"\n<p>India is one of the biggest exporters of medical devices in the world. Earlier, there were laws to regulate medical devices in India. After 2006, The medical devices circulating in India must comply with the rules laid down by the Indian Medical Device Regulations. we discuss CDSCO Medical Devices.<\/p>\n\n\n\n<p>Two regulatory bodies look after\nmanufacturing registration for CDSCO medical devices; these are:<\/p>\n\n\n\n<ul><li><strong>Drug Controller General of India (DCGI)<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup><\/li><li>CDSCO (Central Drugs Standards Control Organisation)<\/li><\/ul>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3a744004342\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3a744004342\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Classification_of_CDSCO_Medical_Devices\" title=\"Classification of CDSCO Medical Devices\">Classification of CDSCO Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#For_which_devices_the_Manufacturing_Registration_can_be_obtained\" title=\"For which devices the Manufacturing Registration can be\nobtained.\">For which devices the Manufacturing Registration can be\nobtained.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Which_entities_can_apply_for_Manufacturing_Registration_for_CDSCO_Medical_Devices\" title=\"Which entities can apply for Manufacturing Registration\nfor CDSCO Medical Devices? \">Which entities can apply for Manufacturing Registration\nfor CDSCO 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:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Details_to_be_declared_to_get_Manufacturing_Registration_for_CDSCO_Medical_Devices\" title=\"Details to be declared to get Manufacturing Registration\nfor CDSCO Medical Devices\">Details to be declared to get Manufacturing Registration\nfor CDSCO Medical Devices<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Manufacturing_Details\" title=\"Manufacturing\nDetails:\">Manufacturing\nDetails:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Product_Details\" title=\"Product Details: \">Product Details: <\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Procedure_to_obtain_Manufacturing_Registration_for_CDSCO_Medical_Devices\" title=\"Procedure to obtain Manufacturing Registration for CDSCO\nMedical Devices \">Procedure to obtain Manufacturing Registration for CDSCO\nMedical Devices <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/swaritadvisors.com\/blog\/manufacturing-registration-for-cdsco-medical-devices\/#Conclusion\" title=\"Conclusion:\">Conclusion:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_CDSCO_Medical_Devices\"><\/span>Classification of CDSCO Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical devices under the CDSCO can be\ndivided into two categories; these are:<\/p>\n\n\n\n<ul><li><strong>Notified Medical Devices:<\/strong> CDSCO has 37 devices that require prior approval before being sold in India. Certification of such devices is mandatory as stated by rule 4 of the Medical Devices Rules, 2017.<\/li><li><strong>Non-Medical Devices:<\/strong> There are no specific regulations for non-medical devices; these can be registered voluntarily with Central Licensing Authority (CLA) as per the medical Device (Amendment) Rules.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"For_which_devices_the_Manufacturing_Registration_can_be_obtained\"><\/span>For which devices the Manufacturing Registration can be\nobtained.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>S.no<\/strong>\n  <\/td><td>\n  <strong>Products<\/strong>\n  <\/td><\/tr><tr><td>\n  1.\n  <\/td><td>\n  Hypodermic Syringes (single-use)\n  <\/td><\/tr><tr><td>\n  2.\n  <\/td><td>\n  Disposable Hypodermic needles\n  <\/td><\/tr><tr><td>\n  3.\n  <\/td><td>\n  Perfusion sets (disposable)\n  <\/td><\/tr><tr><td>\n  4.\n  <\/td><td>\n  Cardiac Stents\n  <\/td><\/tr><tr><td>\n  5.\n  <\/td><td>\n  In-vitro devices for (HIV, HBsAg&nbsp;\n  and HCV)\n  <\/td><\/tr><tr><td>\n  6.\n  <\/td><td>\n  Catheters\n  <\/td><\/tr><tr><td>\n  7.\n  <\/td><td>\n  Drug-eluting Stents\n  <\/td><\/tr><tr><td>\n  8.\n  <\/td><td>\n  Intra Ocular Lenses\n  <\/td><\/tr><tr><td>\n  9.\n  <\/td><td>\n  I.V Cannulae\n  <\/td><\/tr><tr><td>\n  10.\n  <\/td><td>\n  Bone types of Cement\n  <\/td><\/tr><tr><td>\n  11.\n  <\/td><td>\n  Heart Valves\n  <\/td><\/tr><tr><td>\n  12.\n  <\/td><td>\n  Scalp Vein Set\n  <\/td><\/tr><tr><td>\n  13.\n  <\/td><td>\n  Orthopaedic Implants\n  <\/td><\/tr><tr><td>\n  14.\n  <\/td><td>\n  Prosthetic replacements\n  <\/td><\/tr><tr><td>\n  15.\n  <\/td><td>\n  Ablation Devices\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Which_entities_can_apply_for_Manufacturing_Registration_for_CDSCO_Medical_Devices\"><\/span>Which entities can apply for Manufacturing Registration\nfor CDSCO Medical Devices? <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Entities that can apply for Manufacturing\nRegistration for CDSCO Medical Devices are mentioned below:<\/p>\n\n\n\n<ul><li>An Entity has an office listed in India<\/li><li>The authorised agent, through the permission of the manufacturer<\/li><li>Any subsidiary of the manufacturer<\/li><li>A domestic medical device manufacturer<\/li><li>Any other importer.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Details_to_be_declared_to_get_Manufacturing_Registration_for_CDSCO_Medical_Devices\"><\/span>Details to be declared to get Manufacturing Registration\nfor CDSCO Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Manufacturing_Details\"><\/span><strong>Manufacturing\nDetails:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul><li>Documents of the company such as :<ul><li>Memorandum of Association &amp; Article of Association<\/li><li>Partnership deed in case of partnership company<\/li><li>Declaration regarding the names of proprietors\/ Directors\/ partners etc.<\/li><li>Residential address and identification documents of all the partners and directors <\/li><li>Documents for ownership of the site\/rent agreement (if the site is taken up on rent)<\/li><\/ul><\/li><li>A Plant Master File prepared as per the requirements mentioned in appendix 1 of Part III of the fourth schedule) Along with this following documents should be attached to the file<ul><li>Declaration of Manufacturing and Analytical Chemist.<\/li><li>Documents of work experience, qualification, appointment letters, Identification of Chemists.<\/li><li>Consent to operate from the state where the factory is located<\/li><li>Registration certificate from District Industries Centre.<\/li><\/ul><\/li><li>A brief explanation of the manufacturing of the medical devices.<\/li><li>Documents showing the standards followed by the company for manufacturing and product evaluation<\/li><li>A copy of the certifications of devices. For example, the ISO certification<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Product_Details\"><\/span><strong>Product Details: <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul><li>Name of  the brand or proprietor<\/li><li>A concise description of the devices<\/li><li>Category  of the device<\/li><li>The proposed use and method<\/li><li>In which speciality medical speciality device shall be utilised.<\/li><li>The quality and the quantity details of the constituents<\/li><li>Details of the materials used<\/li><li>Details of the procedure and standards used for testing the device<\/li><li>Contraindications, warnings, precautions, potential adverse events and alternate therapy,  wherever applicable.<\/li><li>A descriptive explanation of accessories\/other devices to be used along with the product.<\/li><li>Details regarding the stability of the device<\/li><li>Information regarding the results of clinical trials <\/li><li>If there are any variations in style, shape, or size of the device- if it is      applicable<\/li><li>Labelling details of the product should conform with the <strong><a href=\"https:\/\/swaritadvisors.com\/drug-license\" class=\"text-primary\">Drugs and Cosmetics Rules 1945<\/a><\/strong>.<\/li><li>Promotional literature and physician manual in English (if any)<\/li><li>Sizes and description of the packaging and the packet sizes.<\/li><li>Conditions  for storage <\/li><li>Summary of any problems that are reported.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_obtain_Manufacturing_Registration_for_CDSCO_Medical_Devices\"><\/span>Procedure to obtain Manufacturing Registration for CDSCO\nMedical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Let&#8217;s have a look at the procedure for\nCDSCO medical device registration:<\/p>\n\n\n\n<ul><li>An application is to be made to the state licensing authority to manufacture the notified devices in Form 27.<\/li><li>The application form should be accompanied by the fee as stated in the rules, and the manufacturer must send a copy of the application to the office of DCGI<\/li><li>The applicant must provide the following details to the authorities along with the application.<\/li><li>In case the medical device does not have an evaluation procedure or any benchmark for certification. Then an expert committee shall be set up. This committee shall examine all the information about the device provided by the applicant to examine the product.<\/li><li>After properly assessing the device, the committee shall forward its observations and opinion to the competent authority. The authority, if satisfied, shall grant permission to release the device on the market.<\/li><li>The Centre licensing Authority and State licensing authority shall conduct a  final joint inspection and verification of the product.<\/li><li>If the CLA is satisfied with all the rules and device configurations, it shall issue the license in Form 28.<\/li><\/ul>\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 Central Drug Standard Control Organisation regulates the registration of medical devices. If a manufacturer wants to get his device registered. In that case, he must make the necessary declarations, submit the application form in the prescribed format and comply with all the norms laid down by the CDSCO.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>India is one of the biggest exporters of medical devices in the world. Earlier, there were laws to regulate medical devices in India. After 2006, The medical devices circulating in India must comply with the rules laid down by the Indian Medical Device Regulations. we discuss CDSCO Medical Devices. Two regulatory bodies look after manufacturing [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":11699,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1016],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11698"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=11698"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11698\/revisions"}],"predecessor-version":[{"id":11704,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/11698\/revisions\/11704"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/11699"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=11698"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=11698"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=11698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}