{"id":293817,"date":"2023-06-05T14:00:56","date_gmt":"2023-06-05T08:30:56","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=293817"},"modified":"2023-06-05T10:56:07","modified_gmt":"2023-06-05T05:26:07","slug":"mohfw-notifies-medical-devices-rules-2017-legal-news","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2023\/06\/05\/mohfw-notifies-medical-devices-rules-2017-legal-news\/","title":{"rendered":"MoHFW includes State Medical Devices Testing Labs under the ambit of Medical Devices Rules, 2017"},"content":{"rendered":"
\n

On 2-6-2023, the Ministry of Health and Family Welfare notified the Medical Devices (Amendment) Rules, 2023 to amend the Medical Devices Rules, 2017<\/a>. The provisions came into force on 2-6-2023.<\/p>\n

Key Points:<\/b><\/p>\n

    \n
  1. \n

    In Rule 3, the definition of “State Medical Devices Testing Laboratory”<\/b> has been inserted.<\/p>\n<\/li>\n

  2. \n

    Earlier, Rule 19 used to focus only on the Central Medical Device Testing Laboratory<\/b> but now the heading has been revised to Medical Device Testing Laboratories<\/b> which now includes State Laboratories.<\/p>\n<\/li>\n

  3. \n

    Rule 19(3) has been inserted which focuses on the purpose of establishing State Medical Devices Testing Laboratory:<\/p>\n

      \n
    • \n

      testing and evaluation of medical devices<\/p>\n<\/li>\n

    • \n

      to carry out any other function as may be specifically assigned to it.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n

    • \n

      Rule 19(4) has been inserted which says that the State Government can also designate any laboratory having facility for carrying out test and evaluation of medical devices as State Medical Devices Testing Laboratory if has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.<\/p>\n<\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      On 2-6-2023, the Ministry of Health and Family Welfare notified the Medical Devices (Amendment) Rules, 2023 to amend the Medical Devices Rules, <\/p>\n","protected":false},"author":67515,"featured_media":293809,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[58200,52171,41821,58199],"class_list":["post-293817","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-medical-device-testing-laboratories","tag-medical-devices","tag-mohfw","tag-state-medical-labs"],"yoast_head":"\nMoHFW notifies Medical Devices (Amendment) Rules, 2023 | SCC Blog<\/title>\n<meta name=\"description\" content=\"Ministry of Health and Family Welfare included State Laboratory under Medical Devices Testing Laboratory vide Medical Devices (Amendment) Rules, 2023.\" 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The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.\u00a0 Only 15 categories of medical devices are, at present, regulated as drugs and to\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":340938,"url":"https:\/\/www.scconline.com\/blog\/post\/2025\/02\/10\/medical-device-failures-in-india-determining-the-liability\/","url_meta":{"origin":293817,"position":1},"title":"Medical Device Failures in India — Determining the Liability","author":"Bhumika Indulia","date":"February 10, 2025","format":false,"excerpt":"by Mahip Singh*, Samir Malik** and Maitri Singh***","rel":"","context":"In "DSK Legal"","block_context":{"text":"DSK Legal","link":"https:\/\/www.scconline.com\/blog\/post\/category\/experts_corner\/law-firm\/dsk-legal\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":259005,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/12\/24\/draft-medical-devices-amendment-rules-2021-introduces-unique-device-identification-of-the-medical-device\/","url_meta":{"origin":293817,"position":2},"title":"Draft Medical Devices (Amendment) Rules, 2021 introduces unique device identification of the medical device","author":"Prachi Bhardwaj","date":"December 24, 2021","format":false,"excerpt":"The Ministry of Health and Family welfare notifies the draft Medical Devices (Amendment) Rules, 2021 vide notification dated December 23, 2021, to further amend Medical Device Rules, 2017. The draft amendment amends the Medical Devices Rules, 2017- for rule 46, the following rule shall be substituted: \u00a0 \u201c46. 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No. 40-2\/2020-DMI (A); dated 11th March, 2020 for\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":301031,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/09\/07\/delhi-high-court-upholds-centre-decision-medical-devices-ambit-drugs-drug-regulatory-framework-legal-news\/","url_meta":{"origin":293817,"position":5},"title":"Delhi High Court upholds Centre decision to bring all medical devices under the ambit of \u2018drug\u2019 under Drugs and Cosmetics Act, 1940","author":"Arunima","date":"September 7, 2023","format":false,"excerpt":"The larger public interest, which concerns patient safety, requires that all medical devices be brought within a regulatory regime. 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