{"id":48561,"date":"2022-09-10T11:41:25","date_gmt":"2022-09-10T06:11:25","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48561"},"modified":"2022-09-10T11:41:27","modified_gmt":"2022-09-10T06:11:27","slug":"rules-relating-to-predicate-device-under-mdr-2017","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/rules-relating-to-predicate-device-under-mdr-2017\/","title":{"rendered":"Rules Relating to Predicate Device under MDR, 2017"},"content":{"rendered":"\n<p>A predicate device is a device that most closely resembles the <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device<\/strong><\/a> in terms of indications of use and technological characteristics. A predicate medical device has been registered\/approved in India. It has the same indications\/intentional use, material of construction, and design characteristics as the device being proposed for registration in India. New medical devices are those that have been notified but have not yet been registered in India. A predicate medical device must be registered or approved in India to be considered a new medical device. The Medical Device Advisory Committees (MDAC) are asked for feedback on these medical devices&#8217; safety, efficacy, necessity, and desirability.<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Importance_of_Predicate_Device\" >Importance of Predicate Device<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Predicate_Device_as_per_MDR_2017\" >Predicate Device as per MDR,\n2017<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Conditions_for_a_medical_device_to_be_substantially_equal_to_a_predicate_device\" >Conditions for a medical device\nto be substantially equal to a predicate device<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Conditions_of_import_manufacture_of_the_device_without_a_predicate_device\" >Conditions of import\/\nmanufacture of the device without a predicate device<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Conditions_where_the_device_does_not_have_a_predicate_device_and_new_in-vitro_diagnostic_medical_device\" >Conditions where the device\ndoes not have a predicate device and new in-vitro diagnostic medical device<\/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\/rules-relating-to-predicate-device-under-mdr-2017\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Importance_of_Predicate_Device\"><\/span>Importance of Predicate Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>&nbsp;The importance of predicate and selecting the\nsuitable predicate device from India is essential, and it must be updated by\nthe Central Drug Standard Control Organization CDSCO, which determines product\nefficacy. The registration process can take around six to nine months. When the\nproducts do not have a predicate in India, the processing time will be\nextended, and a special committee is supposed to be formed to determine the\nsafety and efficacy of the products for the Indian market. Predicate\ncomparisons submitted to CDSCO must have a similar Product description,\nIntended use, design, Material of construction, Advantage and disadvantage, and\nContraindication, all required when compared with products that must be\nregistered. <\/p>\n\n\n\n<p>The device\nclassification from CDSCO, which generally classifies the product as CLASS A,\nCLASS B, CLASS C, and CLASS D, is based on the risk involved in product usage.\nProduct Code is another critical category in locating the predicate device,\nregardless of whether they have already registered with CDSCO Classification of\nthe device. Product code is essential in finding predicate devices. A search of\nthe Product code and classification database will yield the device&#8217;s classification.\nThis classification database contains the following information: common name,\nproduct code, registration number, manufacturer information, and Indian agent\ndetails.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Predicate_Device_as_per_MDR_2017\"><\/span>Predicate Device as per MDR,\n2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 3 (zm) of the Medical Device Rules 2017 defines a predicate device as &#8220;a device- first time and first of its kind, approved for manufacture for sale or import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for a licence in India&#8221; <\/p>\n\n\n\n<p>The existence of\na registered predicate device in the market affects the factors like risk\nclassification, grouping, time and costs. If a medical device is having a\nmedical device registered in India, then form MD-14 is for the application\nprocess for the import license. However, if the medical device does not have a\npredicate device registered along with it, then the data like pre-market data\nor post-market clinical data from India can be required along with the registration\napplication as decided by the Subject Expert Committee (SEC) on a case-to-case\nbasis.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_for_a_medical_device_to_be_substantially_equal_to_a_predicate_device\"><\/span>Conditions for a medical device\nto be substantially equal to a predicate device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to the <strong>medical device rules 2017<\/strong><sup><a href=\"https:\/\/www.dfda.goa.gov.in\/circulars-orders-notifications\/notification\/419-medical-device-rules-2017\"><strong>[1]<\/strong><\/a><\/sup>, the application for grant of permission to conduct clinical investigation applies a condition, which says that any Medical device that requires any clinical investigation but is claiming the substantial equivalence to a predicate device cannot be marketed unless the Central Licensing Authority approves it. About this rule, for a device to be substantially equivalent to a predicate device, it has to comply with specific conditions. The conditions which are to be fulfilled to make a device substantially equal to a predicate device are- <\/p>\n\n\n\n<ul><li>The device should have the same intended use and\ntechnological characteristics. <\/li><li>The device can have the same intended use.\nStill, different technological characteristics, and should it should display\nthat the device is safe and it is as effective as the predicate device. <\/li><\/ul>\n\n\n\n<p>It is not necessary for a proposed medical device and the predicate device to be identical to be substantially equal. The factors responsible for the substantial equivalence are-<\/p>\n\n\n\n<ul><li>Intended use<\/li><li>Design<\/li><li>Energy used\/ delivered <\/li><li>Material <\/li><li>Chemical composition<\/li><li>Manufacturing process <\/li><li>Performance <\/li><li>Safety <\/li><li>Effectiveness<\/li><li>Labelling<\/li><li>Biocompatibility<\/li><li>Standards, etc. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_of_import_manufacture_of_the_device_without_a_predicate_device\"><\/span>Conditions of import\/\nmanufacture of the device without a predicate device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To obtain\npermission to import\/manufacture a medical device that does not have its\npredicate device, there are specific standards to be followed. An application\nto obtain approval for import\/ manufacture of such device is made after\ncompleting its clinical investigation to the Central Licensing Authority in\nMD-26. The form is to be submitted by the authorised agent of the\nimporter\/manufacturer, along with the fees specified in the second schedule and\nthe required documents as per part IV of the fourth schedule. <\/p>\n\n\n\n<p>If the medical\ndevice does not have a predicate medical device, indicated in specific\nproblems, the clinical data or the animal data shall be omitted, deferred or\nabbreviated, as per the decisions of the Central Licensing Authority. <\/p>\n\n\n\n<p>The problems for\nthe aforementioned are life-threatening, serious diseases or diseases of\nparticular importance to Indian health, national emergencies, extreme urgency,\nepidemics and medical devices indicated for conditions, diseases for which\nthere is no therapy. <\/p>\n\n\n\n<p>The Central\nLicensing Authority may grant permission for import or manufacture of a device\nwhich does not have a predicate medical device, in the form MD-27. The CLA may\nalso reject the application within 120+30 days (Including an extension period)\nfrom the date of the application. The rejection should be made in writing, with\nthe reasons for the rejection. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_where_the_device_does_not_have_a_predicate_device_and_new_in-vitro_diagnostic_medical_device\"><\/span>Conditions where the device\ndoes not have a predicate device and new in-vitro diagnostic medical device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per MDR 2017,\nthere are conditions for obtaining permission for the purpose of importing or\nmanufacturing a medical device that does not have any predicate medical device\nand a new In vitro diagnostic medical device. As per rules 63 in form MD-27 and\nas per rules 64 in form MD-29, permission for the same is provided, subject to\ncertain conditions. The conditions are as follows-<\/p>\n\n\n\n<ul><li>The medical device must meet the specifications\nincluded with the application.<\/li><li>From the date of market launch, the permit\nholder of Form MD-27 must submit the Periodic Safety Update Report to the\nCentral Licensing Authority. This report must be submitted every six months for\nthe first two years, then annually for the next two years.<\/li><li>The permit holder must notify the Central\nLicensing Authority of the date the medical device will be introduced to the\nmarket.<\/li><li>The permission holder of Form MD-27 shall report\nany suspected unexpected serious adverse event to the Central Licensing\nAuthority within fifteen days of being aware of the event. <\/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 healthcare sector in India is rapidly expanding and is predicted to reach $280 billion by 2025. India has one of the top 20 global markets for medical devices. By 2025, its estimated value, currently $5.2 billion, will rise to $50 billion. However, India does not produce many medical devices domestically and still imports about 70% of them. Medical device manufacturing and maintenance are highly regulated processes. There were no specific medical device laws in India; instead, the 1940 Drugs and Cosmetics Act governed devices. Indian Medical Device Rules, 2017, the new regulations for medical devices in India, were released by the Central Drug Standard Control Organization to fill this gap. The factors that have contributed to the surge in the medical industry include changes in disease burden, shifting consumer preferences, a growing middle class, and an increase in health insurance, medical support, infrastructure development, policy support, and financial incentives.<\/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\/grant-of-test-license-for-import-under-mdr-2017\/\">Grant of Test License for Import under MDR, 2017<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A predicate device is a device that most closely resembles the medical device in terms of indications of use and technological characteristics. A predicate medical device has been registered\/approved in India. It has the same indications\/intentional use, material of construction, and design characteristics as the device being proposed for registration in India. New medical devices [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":48564,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2710],"acf":{"service_id":"385"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":3532,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48561"}],"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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=48561"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48561\/revisions"}],"predecessor-version":[{"id":48577,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48561\/revisions\/48577"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48564"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48561"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48561"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48561"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}