{"id":44695,"date":"2022-06-22T12:37:42","date_gmt":"2022-06-22T07:07:42","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=44695"},"modified":"2022-06-22T12:37:44","modified_gmt":"2022-06-22T07:07:44","slug":"bis-standards-for-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/bis-standards-for-medical-devices\/","title":{"rendered":"Detailed Overview of BIS Standards for Medical Devices"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Bureau of Indian Standards, also known as BIS, was enacted in India through an act named the Bureau of Indian Standards Act, 1986. This organisation is a National Governmental Body in India established by the Ministry of Consumer Affairs and the Food and Public Distribution under the authorisation of the Government of India. The purpose of the Bureau of Indian Standards in relation to <a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical devices<\/strong><\/a> is for the maintenance of the healthcare system and to monitor the quality of devices being used in the medical field for ensuring pertinence the devices are being utilised by following all the safety measures as per authorisation of BIS. <\/p>\n\n\n\n<p>For the purpose of monitoring that the\nmedical devices are being utilised as per the set Indian Standards, there are\nTechnical Committees established by BIS that work under the Medical Equipment\nand Hospital Planning Department, also known as MHD, for regulation over\nmedical devices such as Surgical Equipment, Implants and Accessories, Equipment\nneeded for assisting the Disabled, Surgical Equipment for Veterinary Purposes,\nEquipment needed for experimentation other necessary practices for\nElectromedical and Forensic Science purposes, Equipment utilised in Medical\nLaboratories, Equipment utilised for Health Informatics, etc. <\/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\/bis-standards-for-medical-devices\/#Advantages_of_BIS_Standards_for_Medical_Devices\" >Advantages of BIS Standards for 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:\/\/corpbiz.io\/learning\/bis-standards-for-medical-devices\/#The_Necessity_of_BIS_Standards_for_Medical_Devices\" >The Necessity of BIS Standards for Medical Devices<\/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\/bis-standards-for-medical-devices\/#Implementing_BIS_Standards_For_Medical_Devices\" >Implementing BIS Standards For 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\/bis-standards-for-medical-devices\/#Registration_Conditions_of_BIS_Standards_for_Medical_Devices\" >Registration Conditions of BIS Standards\nfor Medical Devices<\/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\/bis-standards-for-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Advantages_of_BIS_Standards_for_Medical_Devices\"><\/span>Advantages of BIS Standards for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following advantages mentioned below\nare the advantages stated for the implementation of maintenance of BIS Standards for Medical Devices \u2013<\/p>\n\n\n\n<ul><li>Incrementation\nof Efficiency<\/li><li>Reduction\nof Costs<\/li><li>Monitoring\nthe Supply Chain of Medical Devices<\/li><li>Reduction\nof Health Risks and Securement of Safety Measures<\/li><li>Ensuring\nthe maintenance of Medical Devices<\/li><li>Growth\nin the Marketing of Medical Devices<\/li><li>Control\nover Manufacturing of Medical Devices<\/li><li>Providing\nsecurity to the Customer and providing Transparency<\/li><li>Reduction\nin any occurrence of Health Hazards caused due to defects in Medical Devices<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Necessity_of_BIS_Standards_for_Medical_Devices\"><\/span>The Necessity of BIS Standards for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The purpose of the\nImplementation of the BIS Standards for Medical Devices is for complying in\naccordance with the set Indian Standards for maintenance of required safety\nmeasures and for the reduction of any occurrence of health hazards caused due\nto defects in medical devices as per the Quality Management System also known\nas QMS of BIS. <\/p>\n\n\n\n<p>The Quality\nManagement System includes \u2013<\/p>\n\n\n\n<ul><li>Evaluation\nof Risk Factors<\/li><li>Management\nof the authorisation and control over the production of such medical devices<\/li><li>Evaluation\nof medical devices utilised for Clinical Purposes<\/li><li>Verification\nof Bio\u2013Compatibility<\/li><li>The\nEnvironmental Risk Factors of the Medical Devices<\/li><li>Approval\nof the Electronic Devices being utilised for the functioning of Medical Devices<\/li><li>Securement\nof Safety Measures being maintained for the Medical Devices<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Implementing_BIS_Standards_For_Medical_Devices\"><\/span>Implementing BIS Standards For Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In accordance with\nRule 7 of the Medical Device Rules, 2017, it is specified that for the\nfulfilment of set \u201cProduct Standards\u201d of medical devices, all products need to comply\nwith the set Indian Standards as provided by BIS and the latest updated\nstandards specified by the Ministry of Health and Family Welfare also known\nas <strong>MOHFW<\/strong><sup><a href=\"https:\/\/www.mohfw.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> that\nfalls under the authorisation of the Central Government of India. In case there\nis no specific set of Indian Standards specified by BIS or MOHFW, then the\nmedical device is to comply with set standards in accordance with <em>International\nOrganisation for Standardisation, also known as ISO, or the International Electro\u2013Technical\nCommission, also known as IEC, or any relevant Pharmacopeial Standards. In case\nthere are still no relevant standards found that are applicable, then the\nproduct is to comply with the applicable Validated Manufacture\u2019s Standards.<\/em><em><\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registration_Conditions_of_BIS_Standards_for_Medical_Devices\"><\/span>Registration Conditions of BIS Standards\nfor Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the current scenario, there are about\nthirty-eight types of Medical Devices that need to mandatorily obtain the\nImporter License by applying through the Form MD \u2013 15 that falls under the\nauthorisation of the Central Drugs Standard Control Organisation,\nwhich is also known as CDSCO before any initiation of selling the product in\nthe market for maintenance of the set Indian Standards as per BIS.<\/p>\n\n\n\n<p>From 1<sup>st <\/sup>October 2022, the\nfollowing categories mentioned below of Medical Devices have to mandatorily be\nregistered for the issuance of Importer License \u2013<\/p>\n\n\n\n<ul><li>Class \u2013 A Medical Devices<\/li><li>Class \u2013 B Medical Devices<\/li><li>Class \u2013 C Medical Devices<\/li><li>Class \u2013 D Medical Devices<\/li><\/ul>\n\n\n\n<p>The other Non\u2013Notified Medical Devices are\nneeded to be mandatorily registered under the applicable licenses that must\ncomply with the following below\u2013mentioned documentation \u2013<\/p>\n\n\n\n<ul><li>Reference Country Approval<\/li><li>ISO 13458 Certification of the Manufacturing\nFacility<\/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>Recently, there have been discussions held for the purpose of strengthening the set Indian Standards in accordance with the BIS Department of Pharmaceuticals. The Central Drugs Standard Control Organisation, also known as CDSCO, notified on September 2021 that they had added a specific section dedicated to BIS Set Indian Standards for Medical Devices on their website.<\/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\/regulation-for-all-medical-devices-under-cdsco-directive\/\">Regulation for all Medical Devices under CDSCO Directive<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Bureau of Indian Standards, also known as BIS, was enacted in India through an act named the Bureau of Indian Standards Act, 1986. This organisation is a National Governmental Body in India established by the Ministry of Consumer Affairs and the Food and Public Distribution under the authorisation of the Government of India. The [&hellip;]<\/p>\n","protected":false},"author":37,"featured_media":44696,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2445],"acf":{"service_id":"508"},"authorName":"Sushree Dash","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-9.jpg","authorDescription":"Sushree Dash has completed BBA-LLB with a specialization in IPR Laws from KIIT University. As a recent graduate, she has both legal and management internship experience in international law firms, Indian law firms and under Indian litigation. She secures good drafting skills for various legal documents in multiple fields of law. She has also published multiple research papers in reputed UGC approved international journals.","postViews":5519,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44695"}],"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\/37"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=44695"}],"version-history":[{"count":2,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44695\/revisions"}],"predecessor-version":[{"id":44698,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44695\/revisions\/44698"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/44696"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=44695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=44695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=44695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}