{"id":50182,"date":"2022-10-18T15:51:55","date_gmt":"2022-10-18T10:21:55","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50182"},"modified":"2023-04-11T12:07:40","modified_gmt":"2023-04-11T06:37:40","slug":"regulations-on-ultrasound-equipment-import-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/regulations-on-ultrasound-equipment-import-in-india\/","title":{"rendered":"An Overview of Regulations on Ultrasound Equipment Import in India"},"content":{"rendered":"\n<p>The Ministry of Health &amp; Family Welfare has recently come up\nwith a release of notification on 21 October 2020 to extend the timeline from 1\nNovember 2020 to 1 November 2021 for ultrasound equipment, the apex drug\nregulatory body, specifying the Ultrasound equipment intended for internal or\nexternal use in human beings as drugs last year, Central Drugs Standard Control\nOrganization or CDSCO, notified Ultrasound Device as Drugs that was effective\nfrom 1<sup>ST<\/sup> November 2020. A medical ultrasound machine is a diagnostic\nimaging technique based on an ultrasound application that proposes finding a\nsource of disease and excluding pathology using ultrasound equipment. The\nmachine is often misused, violating the provisions of the Pre-Natal Diagnostic\nTechniques (PC-PNDT) and Pre-Conception Act after conception through conducting\nillegal sex determination tests. The stage of government objectives to regulate\nto Import, manufacture, and sale of Ultrasound Equipment will be allowed only\nunder the legal purview of the <strong>Drugs and Cosmetics Act of 1940<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/www.indiacode.nic.in\/bitstream\/123456789\/2409\/1\/a1940-23.pdf\"><strong>[1]<\/strong><\/a><\/sup>. According to the\nministry, this is due to the drastic decline in the sex ratio in India. This\nblog will discuss Regulations on Ultrasound Equipment imported into India.<\/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\/regulations-on-ultrasound-equipment-import-in-india\/#Ultrasound_Equipment_Import_in_India_What_is_Ultrasound_equipment\" >Ultrasound\nEquipment Import in India: What is Ultrasound equipment?<\/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\/regulations-on-ultrasound-equipment-import-in-india\/#Ultrasound_Equipment_Import_in_India_Uses_of_Ultrasound_Equipment\" >Ultrasound\nEquipment Import in India: Uses of Ultrasound Equipment<\/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\/regulations-on-ultrasound-equipment-import-in-india\/#Ultrasound_Equipment_Import_in_India_Indian_Governments_Notification_for_Medical_Devices_under_CDSCO_Regulation\" >Ultrasound\nEquipment Import in India: Indian Governments Notification for Medical Devices\nunder CDSCO Regulation<\/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\/regulations-on-ultrasound-equipment-import-in-india\/#New_Regulation_on_Ultrasound_Equipment_Import_in_India\" >New Regulation\non Ultrasound Equipment Import in India<\/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\/regulations-on-ultrasound-equipment-import-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ultrasound_Equipment_Import_in_India_What_is_Ultrasound_equipment\"><\/span>Ultrasound\nEquipment Import in India: What is Ultrasound equipment?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ultrasound imaging uses high frequency sound waves to view the human\nor animal body. Because ultrasound images are captured in real time, they can\nalso show the movement of the internal body organs and blood flowing through\nthe blood vessels. Unlike X-ray imaging, there is no ionizing exposure\nassociated with ultrasound imaging. In an ultrasound exam, a transducer is\nplaced directly on the inside of a body and skin opening. A thin gel layer is\napplied on the skin so that ultrasound waves are transmitted from the\ntransducer through the gel into the human body. The ultrasound image is\nproduced based on the waves&#8217; reflection off the human body structures. The\namplitude (strength) of the sound signal and the time it takes for the wave to\ntravel through the human body give the details essential to produce an image.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ultrasound_Equipment_Import_in_India_Uses_of_Ultrasound_Equipment\"><\/span>Ultrasound\nEquipment Import in India: Uses of Ultrasound Equipment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ultrasound imaging is a <a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device<\/strong><\/a> that can assist a physician in evaluating and treating a medical condition and diagnosis. Some common ultrasound imaging processes include:<\/p>\n\n\n\n<ul><li>Abdominal ultrasound <\/li><li>Breast ultrasound (to visualize\nbreast tissue)<\/li><li>Ophthalmic ultrasound (to\nvisualize ocular structures<\/li><li>Bone sonometry (to assess bone\nfragility)<\/li><li>Doppler ultrasound (to\nvisualize flow of blood through organs, blood vessels, or other structures)<\/li><li>Doppler fetal heart rate\nmonitors (to listen the fetal heartbeat)<\/li><li>Echocardiogram (to view the\nheart)<\/li><li>Ultrasound guided biopsies (to\ncollect a sample of tissue)<\/li><li>Fetal ultrasound (to view the\nfetus in a woman&#8217;s pregnancy)<\/li><li>Ultrasound guided needle\nplacement (in blood vessels or other tissues of interest)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ultrasound_Equipment_Import_in_India_Indian_Governments_Notification_for_Medical_Devices_under_CDSCO_Regulation\"><\/span>Ultrasound\nEquipment Import in India: Indian Governments Notification for Medical Devices\nunder CDSCO Regulation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Ministry of Health &amp; Family Welfare, Government of India,\nhas, through three notifications dated 27 December 2019 and 21 October 2021,\nextended the effective date of earlier notifications that consecutively brought\n13 new categories of medical devices under CDSCO regulation, also called New\nDevice Notification.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Expansion of Devices<\/strong><\/h3>\n\n\n\n<p>India&#8217;s pharmaceutical regulator and medical device, the Central\nDrugs Standard Control Organisation or CDSCO, has now further granted an\nextension for several medical devices to register for market authorization. The\nCDSCO has expanded and included more types of devices formerly expected to\nregister under India&#8217;s Medical Device Rules, 2017, by 1 January 2020, but now has\nextended the registration deadline to January 2021 under the first\nnotification.<\/p>\n\n\n\n<ul><li>Nebulizers<\/li><li>Glucometers<\/li><li>Digital thermometers <\/li><li>Blood pressure monitoring\nequipment<\/li><\/ul>\n\n\n\n<p>CDSCO will be extended the compliance deadlines for various types of\nother imaging devices in addition to the above medical devices to 1April\nunder the second notification, and these include:<\/p>\n\n\n\n<ul><li>Implantable devices<\/li><li>MRI equipment<\/li><li>X-Ray machines<\/li><li>CT scan equipment<\/li><li>Bone marrow cell separation\ndevice<\/li><li>Defibrillators<\/li><li>Dialysis systems<\/li><li>PET equipment<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"New_Regulation_on_Ultrasound_Equipment_Import_in_India\"><\/span>New Regulation\non Ultrasound Equipment Import in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The government of India Will decide to make the regulations more\nstrict for ultrasound equipment and other imaging machinery to prevent\nimporting these machineries without proper registration. Hence, companies have\npermission from CDSCO to import these machineries into India. As per a recently\nheld meeting, it has been decided by the Drug Technical Advisory Board, which\nis an apex body advising CDSCO on matters related to drugs &amp; cosmetics, to\ninclude the equipment mentioned above and organ preservative solutions as\nmedical devices under currently existing drug regulations of the country. The\nequipment mentioned above herein, now called medical devices, would be included\nunder section 3(b) of the Drugs &amp; Cosmetics Act, 1940. The government has\ntaken the move to regulate the manufacture, Import, and sale of this equipment\nto ensure that they are of high-quality standards and easier for the government\nto track to see that device-related abuse is prohibited, like the use of\nultrasound equipment for sex determination. Earlier, license were not required\nto import ultrasound equipment and other imaging machinery, so it was difficult\nto check the quality of these equipment. Although the sale &amp; registration\nof ultrasound machines are already provided for under the Pre Conception and\nPre Natal Diagnostic Techniques or PC-PNDT Act, 1994 but the recent decision\ntaken from the government would assist in strengthening the adherence to the\nregulation.<\/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>&nbsp;The Health ministry feels that the move is crucial to saving the girl child as it shall check misuse of such techniques for child sex selection after conception. Imported ultrasound machines have flooded the market, and under regulatory law, they cannot be tracked. The move is streamlining the health ministry DTAB or Drug Technical Advisory Board roadmap that aims to regulate each medical equipment in a phased manner and an adequate transition time of nearly four years for high-risk and near-high-risk equipment.<\/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 Ministry of Health &amp; Family Welfare has recently come up with a release of notification on 21 October 2020 to extend the timeline from 1 November 2020 to 1 November 2021 for ultrasound equipment, the apex drug regulatory body, specifying the Ultrasound equipment intended for internal or external use in human beings as drugs [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":50183,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2791],"acf":{"service_id":"385"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":4991,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50182"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50182"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50182\/revisions"}],"predecessor-version":[{"id":54873,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50182\/revisions\/54873"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50183"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50182"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50182"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50182"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}