{"id":46816,"date":"2022-08-17T11:31:36","date_gmt":"2022-08-17T06:01:36","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46816"},"modified":"2022-09-13T18:47:18","modified_gmt":"2022-09-13T13:17:18","slug":"registration-of-software-as-medical-device-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/registration-of-software-as-medical-device-in-india\/","title":{"rendered":"Registration of Software as Medical Device in India"},"content":{"rendered":"\n<p>Software as Medical Device\nis a very fresh topic in the medical industry in India. This outcome is\ntriggered by the adoption of the internet, digital healthcare platforms,\nincreased number of chronic diseases and adoption of software for monitoring\nphysiological parameters by doctors or other healthcare providers.&nbsp;<\/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\/registration-of-software-as-medical-device-in-india\/#Software_as_Medical_Device_in_India\" >Software as Medical Device\nin India<\/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\/registration-of-software-as-medical-device-in-india\/#Software_as_Medical_Device_at_the_Global_level\" >Software as Medical Device\nat the Global level<\/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\/registration-of-software-as-medical-device-in-india\/#Registration_of_Software_as_Medical_Device\" >Registration of Software as\nMedical Device&nbsp;<\/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\/registration-of-software-as-medical-device-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Software_as_Medical_Device_in_India\"><\/span>Software as Medical Device\nin India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In recent years software technologies have brought innovative changes to the healthcare sector. Monitoring, diagnosis, prevention and treatment of diseases or drug manufacturing are dependent on software technologies. On 11th February 2020, the Ministry of Health and Family Welfare, Government of India, widened the scope of medical devices that are regulated under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 by issuing a notification. Any software or app used for diagnosis, prevention or monitoring of any disorder or disease, is part of or used in conjunction with a device or that is capable of or assists in the investigation of any physiological process are included in the meaning of a <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device<\/strong><\/a> and thus regulated as Drug under the 1940 Act effectively from 1st April 2020. For included in the meaning of drugs, this software as a medical device must be used for any of the following:<\/p>\n\n\n\n<ul><li>Diagnosis, monitoring, prevention, treatment or alleviation of any disease or disorder diagnosis, monitoring, treatment, alleviation or assistance for any injury or disability<\/li><li>The investigation, replacement or modification or support of the anatomy or of a physiological process<\/li><li>Supporting or sustaining life&nbsp;<\/li><li>Disinfection of medical devices<\/li><li>Control of conception.<\/li><\/ul>\n\n\n\n<p>Earlier software as a medical device was limited to the context of clinical investigation and in relation to in-vitro devices. With this inclusion, any software falling under the meaning of Drugs as a medical device needs to be registered as per the <strong>Drugs and Cosmetics Act 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup> for its importation, manufacturing, sale or distribution in India. Such registrations are done by a drug regulatory authority or agency, i.e., Central Drug Standards Control Organisation.&nbsp;<\/p>\n\n\n\n<p>Software as Medical Device\nmust fulfil the following criteria:<\/p>\n\n\n\n<ul><li>The intention of the manufacturer is to be used for a medical purpose&nbsp;<\/li><li>Meets the definition of Medical Device as provided under Medical Device Rules<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Software_as_Medical_Device_at_the_Global_level\"><\/span>Software as Medical Device\nat the Global level<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Software technologies in\nthe medical field are accelerated worldwide due to the Covid-19 pandemic. In\nthe whole world, there are three types of software related to a medical device\nsuch as:<\/p>\n\n\n\n<ul><li>Software in Medical Devices, SiMD;<\/li><li>Software as Medical Devices, SaMD and<\/li><li>Software used in manufacturing or maintenance of a medical device<\/li><\/ul>\n\n\n\n<p>There are various uses of\nsoftware in the medical field as a medical device, such as screening,\ndiagnosis, monitoring and alerting, etc. Healthcare agencies of developed\ncountries like the European Union, the United States, Canada and Australia have\ngiven defined regulations for such software uses as a medical device. Some of\nsuch countries have already developed guidelines, and others are in process.\nWorldwide, countries have accepted the harmonised international guidelines for\nevaluating and approving software. Some of the important guidelines available\nfor this software related to a medical device are listed below:<\/p>\n\n\n\n<ul><li>International Medical Device Regulators Forum, IMDRF guidance for classification, Quantity Management System, cybersecurity assessment, clinical evaluation<\/li><li>European Union Medical Device Regulations have detailed information on this device.<\/li><li>MDCG guidance on qualification and classification of it, CER\/PER requirements&nbsp;<\/li><li>US FDA guidance on cybersecurity, clinical evaluation and registration requirements for different types of software, for example, decision systems, PACS, mobile applications, etc.<\/li><li>Health Canada guidance document on definition and classification&nbsp;<\/li><li>TGA&#8217;s new regulations for a software-based medical device became effective from August 2020.<\/li><\/ul>\n\n\n\n<p>The registration of this\nsoftware as medical devices in global markets are handled by a case approach\nand requires close interaction with respective health agency for approval and\nlicensing. The basic steps that are followed for registration of these devices\ninclude:<\/p>\n\n\n\n<ul><li>Determining whether the given software qualifies for software as a medical device or not<\/li><li>Classification of these devices based on the involvement of risk<\/li><li>Identification of applicable standards and data requirements by the respective health authority or agency<\/li><li>Generate the data as required by the concerned health agency or authority&nbsp;<\/li><li>Compilation of technical files as per the country&#8217;s requirements<\/li><li>Submission and query resolution till approval&nbsp;<\/li><li>Post-approval life cycle management&nbsp;<\/li><\/ul>\n\n\n\n<p>The&nbsp;term software as medical device&nbsp;is first time defined by the International Medical Device Regulators Forum (IMDRF) as software that intends to be used for one or more medical purposes and perform these purposes without being part of any hardware medical device. This is a far more purposive definition due to using words for medical purposes.&nbsp;<\/p>\n\n\n\n<p>The European Commission&#8217;s\nMedical Device Coordination Group releases guidance on criteria for software\nqualifications under relevant European Union regulations. The guidance is\nillustrative and includes examples. It is instrumental in the Indian context to\nthe extent the Central Government of India considers subscribing and\nimplementing such guidance from another country.&nbsp;<\/p>\n\n\n\n<p>Therefore, an absence of a\nspecific regulatory framework needed clinically evaluate software as a medical\ndevice restricts the ability of the Central Drugs Standard Control Organisation\nto assure the safety or effectiveness of any software that is essential in\nlight of the result or impact of software in decision making that impacts the\nclinical outcomes and patient care.&nbsp;<\/p>\n\n\n\n<p>In the long run, this\nCentral Drugs Standard Control Organisation, CDSCO adopts international\nstandards and classification schemes where this software is categorised based\non the level of impact on the patient or public health and provides explicit\nexemptions (as adopted by the European Commission\/ International Medical Device\nRegulators Forum (IMDRF) for instance).&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registration_of_Software_as_Medical_Device\"><\/span>Registration of Software as\nMedical Device&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to Medical Device (Amendment) Rules, 2020, manufacturers and importers of all medical devices in India must register their medical devices from 1st October 2021 to 1st October 2022.\u00a0<\/p>\n\n\n\n<p>In order to obtain such\nregistration, the manufacturers and importers of software relating to a medical\ndevice with the Central Standards Control Organisation (CDSCO).&nbsp;<\/p>\n\n\n\n<p>A manufacturer or importer\nof medical devices is the one who can apply for the registration of such\ndevices. For an importer to get registration, it is a pre-requisite to have a\nwholesale drug license; however, CDSCO is currently permitting registration\nwithout such a license.&nbsp;&nbsp;<\/p>\n\n\n\n<p>After submission of the\napplication for registration, a file number is generated, which concludes that\nthe registration process is completed. This file number is the registration\nnumber. This registration is dependent on the manufacturing site, meaning\ndifferent registration numbers are granted for different manufacturing\nsites.&nbsp;<\/p>\n\n\n\n<p>Specific regulatory\nprocesses that are required to be there for considering software as medical\ndevice are as follows:<\/p>\n\n\n\n<ul><li>Risk Management System<\/li><li>Quality Management System<\/li><li>Post Market Surveillance System with PMCF<\/li><li>Clinical Evaluation and Clinical Evaluation Report&nbsp;<\/li><li>All required technical documents<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Objective of registration<\/h3>\n\n\n\n<p>The objective of the Indian\nGovernment behind imposing registration appears to be phase-wise regulation of\nmedical devices. The pre-requisite for getting registration is the existence of\nan ISO 13485 certificate (Quality Management System, QMS for medical devices)\nobtained from a certification body accredited with the International\nAccreditation Forum (IAF) or National Accreditation Board for Certification\nBodies (NABCB) to the manufacturer of software as medical devices. No safety or\neffectiveness data are required to be presented for obtaining\nregistration.&nbsp;<\/p>\n\n\n\n<p>The Government of India\nintends to ensure that by 1st October 2021, all medical devices sold in India\nmust be manufactured where the Quality Management Systems (QMS) meet the\nstandards specified in ISO 13485 as certified by any Accredited Certifying\nBody.&nbsp;&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Information required for\nregistration&nbsp;<\/h3>\n\n\n\n<p>Following information is\nrequired to be provided for obtaining registration:<\/p>\n\n\n\n<ul><li>Details of the manufacturer including name, address, phone no., fax and email id.<\/li><li>Details of the site, including name, address, email id, fax, and contact number<\/li><li>Nature of activity&nbsp;<\/li><li>Category of device<\/li><li>Product Description&nbsp;<\/li><li>Generic name and model number<\/li><li>Intended use<\/li><li>Source\/ material used for manufacturing<\/li><li>Dimension&nbsp;<\/li><li>Shelf life<\/li><li>Storage condition<\/li><li>Brand name (If the applicant has trademark registration)&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Documents required for\nregistration&nbsp;<\/h3>\n\n\n\n<p>Following are the documents\nthat are required for obtaining registration:<\/p>\n\n\n\n<ul><li>ISO 13485 Certificate<\/li><li>Certificate of Foreign Government (for imported devices)<\/li><li>Free Sale Certificate (for imported devices)&nbsp;<\/li><li>Undertaking from the applicant, stating that all information and documents provided are genuine and authentic.&nbsp;<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Consequences of not\nregistering<\/h3>\n\n\n\n<p>A medical device cannot be\nlegally manufactured without registration if there is a requirement for its\nregistration. Before marketing this software as medical device, its manufacturers\nand importers must obtain a registration. If a device is manufactured or\nimported into India for marketing purposes without valid registration, then it\nattracts penal action under the Drugs and Cosmetics Act 1940.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Penalty<\/h3>\n\n\n\n<p>In case the applicant\nsubmits false information or documents, then CDSCO may cancel the whole or a\npart of the registration by making it impossible to sell such software as\nmedical devices in question in India.&nbsp;<\/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>Software as medical device is a newly added device under the Drugs and Cosmetics Act 1940 and Medical Device Rules made thereunder due to the growth of technologies in the health care field. It is something which adds value to the medical field, and it has its own medical purposes. It was added by the Ministry of Health and Family Welfare in February 2020. It is registered the same as other medical devices, so it is also included in the meaning of drugs in our country.&nbsp;<\/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\/different-classes-of-medical-device-their-risk-levels\/\">Different Classes of Medical Device &amp; their Risk Levels \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Software as Medical Device is a very fresh topic in the medical industry in India. This outcome is triggered by the adoption of the internet, digital healthcare platforms, increased number of chronic diseases and adoption of software for monitoring physiological parameters by doctors or other healthcare providers.&nbsp; Software as Medical Device in India In recent [&hellip;]<\/p>\n","protected":false},"author":36,"featured_media":46817,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2605],"acf":{"service_id":"385"},"authorName":"Shambhavi Suyesha","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/03\/IMG-20220324-WA0005.jpg","authorDescription":"Shambhavi holds a strong legal background, having completed her BA LLB and LLM. She is particularly interested in legal research and writing, and wishes to utilise her knowledge to create informative legal content. She is an analytical researcher and keeps herself updated about the current legal affairs. She also holds prior experience in publishing articles on assorted legal areas.","postViews":4683,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46816"}],"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\/36"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46816"}],"version-history":[{"count":17,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46816\/revisions"}],"predecessor-version":[{"id":48681,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46816\/revisions\/48681"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46817"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46816"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46816"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46816"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}