{"id":51102,"date":"2022-12-03T12:22:55","date_gmt":"2022-12-03T06:52:55","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51102"},"modified":"2022-12-03T12:22:57","modified_gmt":"2022-12-03T06:52:57","slug":"udi-system-for-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/udi-system-for-medical-devices\/","title":{"rendered":"A Brief on UDI System for Medical Devices"},"content":{"rendered":"\n<p>A\nUnique Device Identification system or UDI aims to provide a global\nidentification system for medical devices. It requires manufacturers of medical\ndevices to affix a unique alphanumeric or numeric code on the labels of medical\ndevices. The UDI system aims to globally regulate the effective and safe use of\nmedical devices. The United States Food &amp; Drugs Administration (FDA) first\nbrought the UDI guidelines in 2013 and is now a pre-requisite for medical\ndevices manufactured in the United States. Other countries soon followed suit. The\nFDA, the International Medical Device Regulator Forum (IMDRF) and the European\nCommission, which is the European Union&#8217;s regulatory authority for medical\ndevices, have been looking to create a globally applicable UDI system to\nefficiently identify medical devices. Scroll down to check more about UDI System\nfor Medical Devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Benefits of UDI System for Medical Devices<\/strong><strong><\/strong><\/h2>\n\n\n\n<p>The\n<strong>UDI<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/en.wikipedia.org\/wiki\/Unique_Device_Identification\"><strong>[1]<\/strong><\/a><\/sup>\nsystem for medical devices aims to benefit many stakeholders like, inter alia,\nindividual consumers, manufacturers of medical devices, hospitals and other\nsimilar institutions, healthcare providers and authorized healthcare\nauthorities by:<\/p>\n\n\n\n<ul><li>Helping identify counterfeit products\nbeing used in the healthcare sector<\/li><li>Reducing clinical errors through\ndocumenting expiration dates of healthcare products consistently.<\/li><li>Speedy access to information and\nquicker visibility into existing inventory.<\/li><li>Quicker discovery of flaws in medical\ndevice information by requisite authorities<\/li><li>Ensuring that information pertaining\nto implanted devices is retraceable and retained safely.<\/li><\/ul>\n\n\n\n<p>Depending\non the country, the UDI system has two major components to it, namely,\nlabelling and registration on the country-specific database. The UDI for\nmedical devices is issued by GS1 in countries like, inter alia, the USA, China,\nEU, Saudi Arabia, and South Korea based on many regulations in these countries.\nManufacturers looking to supply medical devices in these markets can do so by\nadhering to the standards set out by GS1 to fulfil the requirements of UDI. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Labelling\nRequirements of the UDI System for Medical Devices<\/strong><\/h2>\n\n\n\n<p>The UDI for medical devices is an alphanumeric\nor numeric barcode which is readable by both machines and humans. The UDI is\naffixed either on the packaging of the device or on the device itself and can\nbe used to access all information about the medical device. It is used in two\nforms, namely, 2D code or data matrix and 1D code or linear bar code. UDI\nSystem for Medical Devices has two major components:<\/p>\n\n\n\n<ul><li><strong>UDI Device\nIdentifier or UDI-DI<\/strong><\/li><\/ul>\n\n\n\n<p>The UDI device identifier links the manufacturer\nof the <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical device<\/a><\/strong> to the device itself\nand is associated with the specific model of the medical device. It is the\nstatic portion of the UDI and is also referred to as the Global Trade\nIdentification Number or GSIT. UDI-DI is assigned before deploying a product in\nthe market and can be used to primarily identify characteristics of medical\ndevices in databases of a particular country. Different packaging levels of one\nmedical device can have different UDI-DI. The UDI-DI primarily consists of the\nmanufacturer\u2019s product code, the prefixes of the company and the check\ncharacter.<\/p>\n\n\n\n<ul><li><strong>UDI\nProduction Identifier or UDI-PI<\/strong><\/li><\/ul>\n\n\n\n<p>UDI production identifier is assigned by the\nmanufacturer and refers to the product information of the device and, for\ntissue, human cell, tissue-based or cellular products, a unique identification\ncode. With the exception of the EU database, the UDI-PI values do not show in\nspecific country databases. It is the dynamic or variable part of the UDI and\nidentifies:<\/p>\n\n\n\n<ol><li>Serial\nnumber<\/li><li>Manufacturing\ndate<\/li><li>Medical\ndevice manufacturer&#8217;s batch number or lot number<\/li><li>Expiration\ndate<\/li><li>Any\nother characteristics as per country-specific regulations<\/li><\/ol>\n\n\n\n<p>Requirements for UDI System for Medical\nDevices in India<\/p>\n\n\n\n<p>As per <strong><em>Rule 46 of the Medical Device Rules, 2017<\/em><\/strong>,\nthe fresh UDI Regulations, which will largely harmonize with the\nInternational Medical Device Regulator Forum\u2019s UDI regulations, were to be\nadhered to by manufacturers of medical devices supplying their products in the\nIndian market. Rule 46, as it stood prior to 31 December 2021, mandated that \u201c<em>a\nmedical device approved for manufacture for sale or distribution\/import, shall\nbear a unique device identification which shall contain device identifier &amp;\nproduction identifier\u201d <\/em>by 1 January 2022. However, the Ministry of Health\n&amp; Family Welfare issued a notification on 31 December 2021 and amended Rule\n46 of the Medical Device Rules, 2017. This amendment had the effect of delaying\nthe implementation of the UDI regulations in India and has also forego the\nimplementation of production identifier as it only mentions affixing of \u201c<em>unique\ndevice identification<\/em>\u201d. The new UDI regulations are expected to largely\nconform with the labelling requirements for the UDI system followed in other\ncountries since the intent is to create a globally harmonious system to\nidentify and regulate the usage of medical devices on an international scale.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p>The UDI system for medical devices aims to ensure patient safety and tackle adverse issues by source identification of a medical device through use and distribution. Many countries like the United States of America have already implemented UDI regulations for medical devices, and many countries like, inter alia, India, Australia, Canada, Brazil, China, and Singapore are looking to implement country-specific regulations which harmonize with the global UDI standards. Manufacturers looking to deploy medical devices in the Indian market must keep abreast with the developments in the UDI regulations in the country. With a comprehensive UDI system conforming to global UDI standards in place, it will become easier to identify and reduce medical errors, ensure patient safety, and have speedy access to accurate device information.<\/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\/registration-process-for-medical-devices-in-india\/\">A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Unique Device Identification system or UDI aims to provide a global identification system for medical devices. It requires manufacturers of medical devices to affix a unique alphanumeric or numeric code on the labels of medical devices. The UDI system aims to globally regulate the effective and safe use of medical devices. The United States [&hellip;]<\/p>\n","protected":false},"author":47,"featured_media":51103,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2923],"acf":{"service_id":"385"},"authorName":"Sherin Jose","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image-4-e1668575330329.jpg","authorDescription":"Sherin has degrees in Law and English Literature from the University of Delhi. She is adept at legal research and writing and enjoys discussing and analysing important legal developments. Her primary interests lie in Corporate, FinTech and IPR Law and she is always on the lookout for exploring new developments in the area. She is an avid reader who loves classics and contemporary fiction. She likes to travel, bake and obsess over cat videos in her free time.","postViews":2781,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51102"}],"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\/47"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51102"}],"version-history":[{"count":2,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51102\/revisions"}],"predecessor-version":[{"id":51105,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51102\/revisions\/51105"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51103"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51102"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51102"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51102"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}