{"id":259005,"date":"2021-12-24T11:30:21","date_gmt":"2021-12-24T06:00:21","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=259005"},"modified":"2021-12-24T10:23:23","modified_gmt":"2021-12-24T04:53:23","slug":"draft-medical-devices-amendment-rules-2021-introduces-unique-device-identification-of-the-medical-device","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/12\/24\/draft-medical-devices-amendment-rules-2021-introduces-unique-device-identification-of-the-medical-device\/","title":{"rendered":"Draft Medical Devices (Amendment) Rules, 2021 introduces unique device identification of the medical device"},"content":{"rendered":"

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.<\/p>\n

The draft amendment amends the Medical Devices Rules, 2017- for rule 46, the following rule shall be substituted:<\/p>\n

 <\/p>\n

\u201c46. Unique device identification of the medical device \u2014 With effect from the date as may be specified by Central Government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.\u201d<\/p>\n<\/blockquote>\n

 <\/p>\n

It has been notified that the said draft rules shall be taken into consideration on or after the expiry of a period of five days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in<\/a>.<\/p>\n

 <\/p>\n

\n

*Tanvi Singh, Editorial Assistant has reported this brief.<\/span><\/h4>\n","protected":false},"excerpt":{"rendered":"

The Ministry of Health and Family welfare notifies the draft Medical Devices (Amendment) Rules, 2021 vide notification dated December 23, 2021, to <\/p>\n","protected":false},"author":121,"featured_media":253693,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,13],"tags":[],"class_list":["post-259005","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-statutes"],"yoast_head":"\nDraft Medical Devices (Amendment) Rules, 2021 introduces unique device identification of the medical device | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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medical device vide Draft Medical Devices (Amendment) Rules, 2021","author":"Editor","date":"October 16, 2021","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified the Draft Medical Devices (Amendment) Rules, 2021 vide notification dated October 12, 2021. The Draft Rules amend the Medical Devices Rules, 2017 in the following manner: The amendment provides that a person making an application for registration shall on or before\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\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":274997,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/10\/04\/requirement-to-obtain-registration-certificate-to-sell-any-medical-devices-introduced-vide-medical-devices-fifth-amendment-rules-2022\/","url_meta":{"origin":259005,"position":1},"title":"Requirement to obtain registration certificate to sell any medical devices introduced vide Medical Devices (Fifth Amendment) Rules, 2022","author":"Bhumika Indulia","date":"October 4, 2022","format":false,"excerpt":"\u00a0 \u00a0 On 30-09-2022, the Central Government, after consultation with the Drugs Technical Advisory Board, notified Medical Devices (Fifth Amendment) Rules, 2022 to amend the Medical Devices Rules, 2017. The Rules provides that any person not holding licence and intends to sell medical devices exclusively must obtain registration certificate. Key\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"Ministry of Health and Family Welfare","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":293817,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/06\/05\/mohfw-notifies-medical-devices-rules-2017-legal-news\/","url_meta":{"origin":259005,"position":2},"title":"MoHFW includes State Medical Devices Testing Labs under the ambit of Medical Devices Rules, 2017","author":"Kriti","date":"June 5, 2023","format":false,"excerpt":"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. The provisions came into force on 2-6-2023. Key Points: In Rule 3, the definition of \u201cState Medical Devices Testing Laboratory\u201d has been inserted. Earlier, Rule 19 used\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"ministry of health and family welfare","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/ministry-of-health-and-family-welfare.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/ministry-of-health-and-family-welfare.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/ministry-of-health-and-family-welfare.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/ministry-of-health-and-family-welfare.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":153214,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/08\/30\/categories-m-n-motor-vehicles-sold-on-and-after-1st-oct-to-be-fitted-with-fastag\/","url_meta":{"origin":259005,"position":3},"title":"Categories M & N motor vehicles sold on and after 1st Oct. to be fitted with FASTag","author":"Saba","date":"August 30, 2017","format":false,"excerpt":"G.S.R. 1112(E).\u2014 The following draft rules further to amend the Central Motor Vehicles Rules, 1989, which the Central Government proposes to make in exercise of the powers conferred by Section 110 of Motor Vehicles Act, 1988 (59 of 1988) is hereby published as required by sub-section (1) of Section 212\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":274541,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/09\/27\/registration-of-international-mobile-equipment-identity-number-vide-prevention-of-tampering-of-the-mobile-device-equipment-identification-number-amendment-rules-2022\/","url_meta":{"origin":259005,"position":4},"title":"Registration of International Mobile Equipment Identity Number vide Prevention of tampering of the Mobile Device Equipment Identification Number (Amendment) Rules, 2022","author":"Bhumika Indulia","date":"September 27, 2022","format":false,"excerpt":"\u00a0 \u00a0 The Central Government has notified Prevention of tampering of the Mobile Device Equipment Identification Number (Amendment) Rules, 2022 to amend the prevention of tampering of the Mobile Device Equipment Identification Number, Rules, 2017. The amendment inserts a new Rule dealing with Registration of International Mobile Equipment Identity Number\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"Central Government Notification","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-226.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-226.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-226.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-226.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-226.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":248978,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/06\/01\/eu-medical-devices-regulation-mdr-comes-into-force\/","url_meta":{"origin":259005,"position":5},"title":"EU Medical Devices Regulation (MDR) comes into force","author":"Bhumika Indulia","date":"June 1, 2021","format":false,"excerpt":"On May 26, 2021 the EU Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. The Regulation introduces various changes which will have an effect on the supply chain for medical devices. \u00a0 Mr. Murali Neelakantan says that \"MDR requires Pharma companies to display unique device identification\u2026","rel":"","context":"In "Foreign Legislation"","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/259005","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/121"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=259005"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/259005\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/253693"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=259005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=259005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=259005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}