{"id":51505,"date":"2022-12-27T15:43:56","date_gmt":"2022-12-27T10:13:56","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51505"},"modified":"2024-05-18T14:08:34","modified_gmt":"2024-05-18T08:38:34","slug":"advance-wearable-medical-devices-in-healthcare","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/advance-wearable-medical-devices-in-healthcare\/","title":{"rendered":"All You Need to Know About Wearable Medical Devices"},"content":{"rendered":"\n<p>Today devices are widely\nused in all branches of medicine, surgery, and community care.Medical development in terms of drugs\nand devices has brought about a robust change in the life of people (as offered\nby cosmetic treatment, dentists, face and cardiology devices).A medical device is classified in\naccordance with Schedule M-III, which gives it a unique classification apart\nfrom the category of drugs. FitBits and smartwatches are already widely\naccepted due to the integration of wearable fitness technology into society,\nand the market for these devices is only expected to expand in the near future.\nIn this blog, we will discuss more <strong>Wearable Medical\nDevices.<\/strong><strong><\/strong><\/p>\n\n\n\n<p>With the increasing\ndemand for consumers to monitor their health and keep track of their vital\nsigns, the use of wearable technology has more than tripled in the last four\nyears. According to the studies, more than 80% of consumers are willing to wear\nfitness technology.<\/p>\n\n\n\n<p>Understanding the\nregulatory reforms imminent in India will be crucial for foreign companies and\nmanufacturers looking to enter or expand their business in medical markets.\nThis article highlights current regulations pertaining to applications for wearable\n<strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical device registration<\/a> <\/strong>and certification. <\/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\/advance-wearable-medical-devices-in-healthcare\/#What_are_Wearable_Medical_Devices\" >What are Wearable\nMedical 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\/advance-wearable-medical-devices-in-healthcare\/#Benefits_of_Wearable_Medical_Devices\" >Benefits of Wearable 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\/advance-wearable-medical-devices-in-healthcare\/#Challenges_Associated_with_Wearable_Medical_Devices\" >Challenges Associated with Wearable 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\/advance-wearable-medical-devices-in-healthcare\/#Indias_Medical_Device_Quality_Regulation\" >India\u2019s Medical Device Quality Regulation<\/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\/advance-wearable-medical-devices-in-healthcare\/#What_is_Medical_Devices_Amendment_Rules_2020\" >What is\nMedical Devices (Amendment) Rules, 2020?<\/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\/advance-wearable-medical-devices-in-healthcare\/#What_are_the_Requirement_for_Registration_Wearable_Medical_Devices\" >What are the Requirement\nfor Registration Wearable Medical Devices?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/advance-wearable-medical-devices-in-healthcare\/#What_are_the_ramifications_of_not_registering_a_wearable_medical_device\" >What are the ramifications of not registering a wearable medical device?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/advance-wearable-medical-devices-in-healthcare\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_Wearable_Medical_Devices\"><\/span>What are Wearable\nMedical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Electronic devices that\nconsumers may wear, like Fitbits and smartwatches, and which are made to\ncollect information on users&#8217; individual health and exercise habits, are\nreferred to as wearable medical devices in the healthcare industry. These\ngadgets can even transmit a user&#8217;s medical data to a physician or other\nhealthcare expert in real-time.<\/p>\n\n\n\n<p><strong><em>Some of the\nsimplest and most original forms of wearable technology, or wearable fitness\ntrackers, are<\/em><\/strong><strong><em>:<\/em><\/strong><strong><em><\/em><\/strong><\/p>\n\n\n\n<ul>\n<li><strong>Wristbands<\/strong>: They are equipped with sensors to keep\ntrack of user&#8217;s physical activities and heart rate. They also provide wearers\nwith health and fitness recommendations by syncing to various smartphone apps.<\/li>\n\n\n\n<li><strong>Wearable ECG monitors<\/strong>: They are on the cutting edge of wearable\nmedical devices, and what sets these monitors apart from some smartwatches is\ntheir ability to measure electrocardiograms or ECGs. The Move ECG has the\nability to measure an electrocardiogram, identify atrial fibrillation, and\ntransmit the reading to the user&#8217;s physician. Furthermore, it has automated\ntracking for walking, running, swimming, and bicycling. It can also measure\npace, distance, and elevation.<\/li>\n\n\n\n<li><strong>Wearable\nBlood Pressure Monitors<\/strong>: Wearable blood pressure\nmonitors use technology that is linked to the user&#8217;s body to continuously check\nblood pressure, even while they are sleeping, exercising, or doing other\nthings. An app is used to store and evaluate the data.<\/li>\n\n\n\n<li><strong>Biosensors<\/strong>:\nThey are emerging wearable medical devices that differ significantly from smartwatches\nand wrist trackers. The self-adhesive patch of the biosensor allows patients to\nroam around while gathering information on their temperature, heart rate,\nrespiration rate, and activity. <\/li>\n<\/ul>\n\n\n\n<p><strong><em>Examples of medical\nwearable start-ups: <\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Augmedix<\/li>\n\n\n\n<li>GOQii<\/li>\n\n\n\n<li>Proteus digital health<\/li>\n\n\n\n<li>Bagmo<\/li>\n\n\n\n<li>ten3T Healthcare<\/li>\n\n\n\n<li>Neurotech<\/li>\n\n\n\n<li>ActoFit wearables<\/li>\n\n\n\n<li>Helfis<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Benefits_of_Wearable_Medical_Devices\"><\/span><strong>Benefits of <\/strong>Wearable Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Wearable technology has several advantages for the user, making them one\nof the most popular technologies for preserving health and wellness in modern\nsociety.&nbsp;We have analysed some of the benefits associated with wearable\nwhich are as follows: <\/p>\n\n\n\n<ul>\n<li><strong>Way to\nAchieve Good Healthcare<\/strong><\/li>\n\n\n\n<li><strong>Mobility\nand Versatility<\/strong><\/li>\n\n\n\n<li><strong>Ideal\nOption for Chronic Diseases<\/strong><\/li>\n<\/ul>\n\n\n\n<p>In addition to being used for personal health, these devices are also\nused as secondary diagnostic tools for the management and prevention of\nillnesses and chronic conditions like obesity, panic disorders, posttraumatic\nstress disorders, asthma, depression, Parkinson&#8217;s disease, and sleep\napnea.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Challenges_Associated_with_Wearable_Medical_Devices\"><\/span>Challenges Associated with Wearable Medical Devices<strong> <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Wearables and medical\ndevices<strong>&nbsp;<\/strong>pose a risk\nthat can harm the person physically and psychologically. We have analysed some\nof the risks associated with wearable which are as follows: <\/p>\n\n\n\n<ul>\n<li><strong>Cyber Risks<\/strong><\/li>\n\n\n\n<li><strong>Technical Issues&nbsp;<\/strong><\/li>\n\n\n\n<li><strong>Regulatory Issues<\/strong><\/li>\n\n\n\n<li><strong>Digital Divide&nbsp;<\/strong><\/li>\n\n\n\n<li><strong>Technology Errors <\/strong><\/li>\n<\/ul>\n\n\n\n<p>In addition to these concerns, wearable technology is frequently linked\nto health problems like cancer because of the radiation it emits when in direct\ncontact with the skin or in close proximity to key organs for a prolonged\nperiod of time. Other health problems cited in connection with wearable\ntechnology, aside from cancer, include headaches, nausea, and a host of other\nsymptoms. However, to acquire a comprehensive picture, more thorough study and\nstudies are needed because these claims lack specific data.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indias_Medical_Device_Quality_Regulation\"><\/span>India\u2019s Medical Device Quality Regulation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drugs and Cosmetics Act\nof 1940 governs the quality and\nsafety requirements for medical devices in India (DCA). The DCA only applies to\nmedical devices that are occasionally classified as &#8220;drugs&#8221; by the\ngovernment (often referred to as &#8220;notified medical devices&#8221;).<\/p>\n\n\n\n<p>The <strong>Medical\nDevices Rules of 2017<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Acts-and-rules\/Medical-Devices-Rules\/\"><strong>[1]<\/strong><\/a><\/sup> (MDR) were established in accordance with the Drugs\nand Cosmetics Act. These regulations develop stringent quality standards for\nmanufacturers, importers, producers, and sellers of notified medical devices.<\/p>\n\n\n\n<p>The Drugs &amp; Cosmetics Act of 1940 and the\nMedical Devices Rules of 2017 are in charge of enforcing a mandatory licence\nrequirement to ensure the quality and the safety of medical devices at all\nstages of the supply chain; as a result, all importers, producers, and sellers\nof wearable medical devices must get a licence from the relevant licencing body\nbefore engaging in any commerce. <\/p>\n\n\n\n<p>A\nlicence is only granted following quality assessments with that the licence\nholder&#8217;s place of business is inspected on a regular basis. Additionally, a\nlicence holder is required to keep thorough records of all sales and purchases\nmade in connection with notified medical devices and to ensure traceability in\nthe event of a quality- or safety-related concern.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Medical_Devices_Amendment_Rules_2020\"><\/span>What is\nMedical Devices (Amendment) Rules, 2020?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On April 1, 2020, the Indian law governing the\nquality and safety of medical devices was amended, and the status of a medical\ndevice was expanded beyond the 23 previously notified medical devices,\nmandating that all medical devices be registered under The Drugs &amp;\nCosmetics Act of 1940. <\/p>\n\n\n\n<p><strong><em>The consequence of the amendment in law is as\nfollows:<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Before&nbsp;<strong>October\n1, 2021<\/strong>, all currently unregulated medical devices will have to be\nregistered by the importers\/manufacturers with the Drugs Controller General of\nIndia (DGCI). However, those medical devices which are regulated\/have been\nnotified to be regulated are exempted from the requirement of registration. <\/li>\n\n\n\n<li>Before&nbsp;<strong>October\n1, 2022,<\/strong>&nbsp;importers or the manufacturers of presently unregulated Class\nA (low-risk) &amp; Class B (low-medium risk) medical devices sold in India will\nhave to compulsorily obtain a license.<\/li>\n\n\n\n<li>Before&nbsp;<strong>October\n1, 2023<\/strong>, importers and the manufacturers of presently unregulated Class C\n(medium-high risk) &amp; Class D (high risk) medical devices sold in India will\nhave to mandatorily obtain a license.<\/li>\n<\/ul>\n\n\n\n<p>Medical device importers and manufacturers must\nacquire ISO-13485 compliance certification in order to register their products.\n<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Requirement_for_Registration_Wearable_Medical_Devices\"><\/span>What are the Requirement\nfor Registration Wearable Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The manufacturers or importers of wearable medical devices must\ncompulsorily register their medical devices with the Drugs Controller General\nof India (DCGI). If an importer or a manufacturer is unable to obtain\nregistration for its wearable medical device, then they will not be able to\nmarket and sell their medical device in India until a registration number is\nobtained. The Drugs Controller General of India will start accepting\napplications for registration through a dedicated online portal called \u201cOnline\nSystem for Medical Devices\u201d. There is no time frame prescribed as of now for\nprocessing the application for registration by DCGI. It &nbsp;the registration will be done instantly after\nthe submission of all information and documents on the online portal.<\/p>\n\n\n\n<p>The registration process is relatively more straightforward. Any\nimporter or manufacturer of wearable medical devices will be able to obtain\nregistration on the submission of the following information:<\/p>\n\n\n\n<ol>\n<li>Name of the\ncompany\/firm\/any other entity<\/li>\n\n\n\n<li>Name &amp; address of\nmanufacturing site (for devices manufactured in India only)<\/li>\n\n\n\n<li>Specification\n&amp;&nbsp; standards of medical device (for\nimported devices only)<\/li>\n\n\n\n<li>Details of medical\ndevices (which icludes: Generic Name, Model No., Intended Use, Class of Medical\nDevice, Material of Construction, Dimensions (if applicable), Shelf Life,\nSterile\/Non-sterile status, Brand name or Trademark only if registered under India&#8217;s\ntrade mark law)<\/li>\n\n\n\n<li>Certificate of\ncompliance concerning ISO 13485 standard accredited by NABCB or National\nAccreditation Board for Certification Bodies\/International Accreditation Forum\n(IAF) in respect of such medical device<\/li>\n\n\n\n<li>Free Sale Certificate\n(FSC) from country of origin (for imported devices only)<\/li>\n\n\n\n<li>A duly-signed\nundertaking stating that the information furnished by the applicant is true and\nauthentic<\/li>\n\n\n\n<li>The registration will\nbe completed only upon the generation of a registration number.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_ramifications_of_not_registering_a_wearable_medical_device\"><\/span>What are the ramifications of not registering a wearable medical device? <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>If an importer or manufacturer of a wearable\nmedical device fails to get a registration, the importer or manufacturer must\nstop importing or manufacturing the medical device until the registration is\nobtained. <\/p>\n\n\n\n<p>The DCGI or State-level Licensing Authority will\nbe able to quickly determine whether a medical device is manufactured or\nimported without registration. According to the Legal Metrology (Packaged\nCommodities) Rules, 2011, every manufacturer and importer of a medical device\n(whether regulated or unregulated) must indicate the date of manufacturing or\ndate of import on the device&#8217;s label. Therefore, if a medical device has a\ndeclaration on its label stating that it was imported or manufactured on or\nafter October 1, 2021, but the label lacks a DCGI registration number, DCGI or\nthe appropriate State-level Licensing Authorities will confiscate the medical\ndevice and take appropriate legal action against the importer or manufacturer.\nAny MDR infraction, including failing to register or receive a licence before\nthe deadline, may result in criminal charges, which include imprisonment and a\nfine. Any stock of hospital devices that is sold without registration or\nauthorisation risked being seized as well.<\/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>A wearable medical device is characterised as a device that is autonomous, non-invasive, and that carries out a specific medical function, such as monitoring or support, for an extended period of time. As implied by the word &#8220;wearable,&#8221; the device is either supported by the user&#8217;s body or their clothing. This decade has seen a tremendous increase in the usage of wearable medical equipment, classified into three forms: wearable monitoring devices, wearable rehabilitation devices, and wearable medical aids. Medical devices have significantly improved health and quality of life by enhancing physicians&#8217; capacity to identify and treat diseases. Despite the global economic slowdown, the Indian medical device business is expanding at a rapid pace. Wearable medical gadgets are intended to help patients with temporary or permanent disabilities in the long run. Numerous vital indicators, including the electrocardiogram (ECG), respiration, skin temperature, pulse, blood pressure, body kinematics, etc., can be continuously monitored by patients. <\/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\/cdsco-medical-device-registration-for-defibrillators\/\">CDSCO Medical Device Registration For Defibrillators \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today devices are widely used in all branches of medicine, surgery, and community care.Medical development in terms of drugs and devices has brought about a robust change in the life of people (as offered by cosmetic treatment, dentists, face and cardiology devices).A medical device is classified in accordance with Schedule M-III, which gives it a [&hellip;]<\/p>\n","protected":false},"author":48,"featured_media":51506,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2984],"acf":{"service_id":"508"},"authorName":"Astitva Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/12\/MicrosoftTeams-image-27.jpg","authorDescription":"Astitva Kumar is an advocate by profession and has completed her BBA. LLB from IP University. She is an avid reader, researcher, and legal writer. Her areas of interest include mediation, conflict resolution, finance, cyber laws, and taxation.","postViews":3725,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51505"}],"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\/48"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51505"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51505\/revisions"}],"predecessor-version":[{"id":64223,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51505\/revisions\/64223"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51506"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51505"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51505"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51505"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}