{"id":5800,"date":"2019-10-21T11:07:37","date_gmt":"2019-10-21T11:07:37","guid":{"rendered":"https:\/\/www.dailyrounds.org\/blog\/?p=5800"},"modified":"2019-10-21T11:07:37","modified_gmt":"2019-10-21T11:07:37","slug":"govt-to-bring-all-medical-devices-under-a-single-regulatory-framework","status":"publish","type":"post","link":"https:\/\/www.dailyrounds.org\/blog\/govt-to-bring-all-medical-devices-under-a-single-regulatory-framework\/","title":{"rendered":"Govt to bring all medical devices under a single regulatory framework"},"content":{"rendered":"<p><span data-preserver-spaces=\"true\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone  wp-image-5801\" src=\"https:\/\/www.dailyrounds.org\/blog\/wp-content\/uploads\/2019\/10\/imh.jpg\" alt=\"\" width=\"930\" height=\"488\" srcset=\"https:\/\/www.dailyrounds.org\/blog\/wp-content\/uploads\/2019\/10\/imh.jpg 764w, https:\/\/www.dailyrounds.org\/blog\/wp-content\/uploads\/2019\/10\/imh-300x157.jpg 300w, https:\/\/www.dailyrounds.org\/blog\/wp-content\/uploads\/2019\/10\/imh-500x262.jpg 500w\" sizes=\"auto, (max-width: 930px) 100vw, 930px\" \/>The Union Health Ministry has issued a draft notification which intends to regulate all the medical devices used on human beings and animals in the country. The draft also makes it mandatory for all the devices to get certified by India\u2019s drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO).\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">At present only 23 medical devices are regulated under the Drugs and Cosmetics act 1940. In the new draft, almost 36 devices including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others are included.\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">For now, the health ministry has decided to bring all medical devices under the Drugs and Cosmetics Act until separate legislation is enacted. \u201cIn pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December 2019,\u201d reads the draft notification dated Oct 18.\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Once notification comes into effect, the Central Drugs Standard Control Organisation (CDSCO) will be the nodal authority to investigate the quality, safety-related failure, complaints and can suspend the registration based on the outcome of the investigation.\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">\u201cThe Health Ministry\u2019s proposal to regulate all medical devices will allow Indian patients access to quality medical devices, and also put a check on garage manufacturing. Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognizance of industry concerns,\u201d said Pavan Choudary, director-general and chairman, Medical Technology Association of India (MTaI).<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Source: Economic Times, Hindustan Times.\u00a0<\/span><\/p>\n<h1><\/h1>\n","protected":false},"excerpt":{"rendered":"<p>The Union Health Ministry has issued a draft notification which intends to regulate all the medical devices used on human beings and animals in the country. The draft also makes it mandatory for all the devices to get certified by India\u2019s drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO).\u00a0 At present only 23 medical [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":5801,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[5],"tags":[26],"class_list":["post-5800","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-medical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Govt to bring all medical devices under a single regulatory framework - DailyRounds<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dailyrounds.org\/blog\/govt-to-bring-all-medical-devices-under-a-single-regulatory-framework\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Govt to bring all medical devices under a single regulatory framework - DailyRounds\" \/>\n<meta property=\"og:description\" content=\"The Union Health Ministry has issued a draft notification which intends to regulate all the medical devices used on human beings and animals in the country. 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