{"id":43926,"date":"2022-05-31T12:30:07","date_gmt":"2022-05-31T07:00:07","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=43926"},"modified":"2022-05-31T12:30:47","modified_gmt":"2022-05-31T07:00:47","slug":"cdsco-medical-devices-manufacturing-registration-requirement","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-devices-manufacturing-registration-requirement\/","title":{"rendered":"CDSCO Medical Devices Manufacturing Registration Requirement"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Drug and Cosmetic Act mandates Medical Devices manufacturers to avail license from CDSCO from commencing the production undertaking. <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical device licensing<\/strong><\/a> with CDSCO is a complicated procedure, and thus it should be pursued under the expert\u2019s supervision. This article discusses the CDSCO Medical Devices Manufacturing Registration Requirement in detail.<\/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-devices-manufacturing-registration-requirement\/#General_CDSCO_Medical_Devices_are_covered_under_the_Drugs_and_Cosmetics_Act\" >General CDSCO Medical Devices are covered\nunder the Drugs and Cosmetics Act<\/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-devices-manufacturing-registration-requirement\/#CDSCO_Medical_Devices_Manufacturing_Registration_Form_and_other_key_Requirements\" >CDSCO Medical Devices Manufacturing\nRegistration Form and other key Requirements<\/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-devices-manufacturing-registration-requirement\/#An_overview_of_Site_Master_Plan\" >An overview of Site Master Plan<\/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-devices-manufacturing-registration-requirement\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"General_CDSCO_Medical_Devices_are_covered_under_the_Drugs_and_Cosmetics_Act\"><\/span>General CDSCO Medical Devices are covered\nunder the Drugs and Cosmetics Act<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It\u2019s been two years since the <strong>Ministry of Health and Family Welfare<\/strong><sup><a href=\"https:\/\/www.mohfw.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> brought the medical device under the Drugs and Cosmetics Act by including them under the Drug category. <\/p>\n\n\n\n<p><strong><em>General CDSCO\nmedical devices that can be found under the said legislation include;<\/em><\/strong><\/p>\n\n\n\n<ul><li>Prosthetic\nReplacements,<\/li><li>Needle<\/li><li>Stents<\/li><li>Syringes<\/li><li>Condoms<\/li><li>Sutures<\/li><li>Ligatures<\/li><li>Nebulizers<\/li><li>Digital\nThermometers<\/li><li>Monitoring\nMachines<\/li><li>Blood Bags<\/li><li>Intravenous\nCannulae<\/li><li>Staplers<\/li><\/ul>\n\n\n\n<p><strong><em>CDSCO mandates\nproducers and importers of such devices to share the following information for\nregistration purpose.&nbsp; <\/em><\/strong><\/p>\n\n\n\n<ul><li>Generic name, <\/li><li>Model number, <\/li><li>Intended use<\/li><li>Class of medical device<\/li><li>Material of construction<\/li><li>Dimensions,<\/li><li>Shelf life and brand name<\/li><\/ul>\n\n\n\n<p>As soon as the\nregistration is available, the applicant becomes liable to affix the\nregistration number on the licensed devices. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Medical_Devices_Manufacturing_Registration_Form_and_other_key_Requirements\"><\/span>CDSCO Medical Devices Manufacturing\nRegistration Form and other key Requirements<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li>Applicant seeking a manufacturing license for medical devices needs to approach the state\u2019s drug authority and submit a duly filled application (Form 27) along with the required documentation and fees. Also, the application should be accompanied by a copy to the office of DCG (I).<\/li><li>The applicant must share the following detail and the prescribed application for consideration by governing authority. <\/li><\/ol>\n\n\n\n<p><strong><em>Manufacturing\nDetails<\/em><\/strong><\/p>\n\n\n\n<ul><li>Complete particulars relating to the company\u2019s directors and the company in question, such as a name, and address.<\/li><li>Completed details relating to the manufacturer\u2019s registered office. <\/li><li>A detailed project reflecting the company\u2019s plan, devices to be manufactured, their intended uses and other relevant profiles. <\/li><li>Copy relating to the Site Master File <\/li><li>Description relating to the manufacturing process of the proposed CDSCO medical devices<\/li><li> Details of the provisions followed by the applicant firm for product evaluation and Good Manufacturing Practices. <\/li><li>Contact and other key details of&nbsp; technical staff accountable for producing medical devices<\/li><li>Copies of ISO or other relevant certification, if any, <\/li><\/ul>\n\n\n\n<p><strong><em>Product\nDetails:- <\/em><\/strong><\/p>\n\n\n\n<ul><li>Proprietary\/Brand name. <\/li><li>Category of device. <\/li><li>Brief description of the device.<\/li><li>Intended use and method of use.<\/li><li>Medical speciality in which the device is used.<\/li><li>Qualitative as well as quantitative particulars of the constituents. <\/li><li>Specifications of the materials utilized.<\/li><li>Testing facilities are present in the production facility for testing. <\/li><li>Standards and procedures followed by the applicant firm for testing the device. <\/li><li>Detail relating to contraindications, warnings, and precautions tagged with the medical products. <\/li><li>List of accessories and other equipment or devices to be utilized in combination with the device. Other key information, including accessories packaged with the medical products. <\/li><li>Information pertaining to the product\u2019s stability. <\/li><li>Particulars around the clinical trials conducted on the product. <\/li><li> Deviation, style, shape or size of the medical device, if applicable. <\/li><li>Labeling particulars that are in line with Drugs and Cosmetics Rules, 1945 <\/li><li>Physician manual and promotional literature (printed in English), if any <\/li><li>Packaging description, including pack sizes. <\/li><li>Recommended storage conditions. <\/li><li>Detailed report of any reported problems. <\/li><\/ul>\n\n\n\n<ol><li>For the vetting purpose of the medical devices which are new or lack any benchmark certification, an expert committee shall be established to vet information shared by the application for the device\u2019s assessment. <\/li><li>Post completion of the assessment, the committee, shared the opinion regarding the viability of the CDSCO medical devices to the concerned department for the issuance of approval. <\/li><li>The State Licensing Authority, post collective vetting, shall forward the license to the CLAA for approval.<\/li><li>The licensing authority shall confer the license in form 28 post due to approval of CLAA.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"An_overview_of_Site_Master_Plan\"><\/span>An overview of Site Master Plan <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The site master\nplan is prepared by the pharmacy company and it encloses details around; <\/p>\n\n\n\n<ul><li>Quality management policies (including those based on GMP)&nbsp; <\/li><li>Undertakings of the production facility<\/li><li>Manufacturing operations <\/li><li>any closely integrated operations at nearby premises, if any <\/li><\/ul>\n\n\n\n<p>Site Master\nFile must not contain anything other than specific details. For example, in the\ncase of partial production, there is no requirement to add detail of an entire\nproduction process in the Site Master File. The site Master File should be as\npictorial as possible when disclosing schematic layouts. The usage of\nnarratives should be minimal in this context.<\/p>\n\n\n\n<p>Even the\nslightest alternation in the QMS or production technique should be reflected in\nthe site master plan. <\/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>CDSCO Medical Devices Manufacturing Registration adheres to different technicalities which might seek expert advice. These include the preparation of a site plan, the appointment of authorized personnel if the applicant belongs to a foreign territory, procurement of a GMP certificate, and so forth. Thus, it is advisable to get in touch with Professional Avenue like Corpbiz to help overcome such obstacles with ease. <\/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\/classification-of-medical-devices-by-cdsco\/\">Classification of Medical Devices by CDSCO: An Overview\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Drug and Cosmetic Act mandates Medical Devices manufacturers to avail license from CDSCO from commencing the production undertaking. Medical device licensing with CDSCO is a complicated procedure, and thus it should be pursued under the expert\u2019s supervision. This article discusses the CDSCO Medical Devices Manufacturing Registration Requirement in detail. General CDSCO Medical Devices are covered [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":43929,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2388],"acf":{"service_id":"508"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":3856,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43926"}],"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\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=43926"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43926\/revisions"}],"predecessor-version":[{"id":43941,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43926\/revisions\/43941"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/43929"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=43926"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=43926"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=43926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}