{"id":255758,"date":"2021-10-16T18:00:49","date_gmt":"2021-10-16T12:30:49","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=255758"},"modified":"2021-10-16T16:36:47","modified_gmt":"2021-10-16T11:06:47","slug":"applicant-shall-submit-an-undertaking-for-registration-of-medical-device-vide-draft-medical-devices-amendment-rules-2021","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/10\/16\/applicant-shall-submit-an-undertaking-for-registration-of-medical-device-vide-draft-medical-devices-amendment-rules-2021\/","title":{"rendered":"Applicant shall submit an undertaking for registration of medical device vide Draft Medical Devices (Amendment) Rules, 2021"},"content":{"rendered":"<p style=\"text-align: justify;\">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:<\/p>\n<ul style=\"text-align: justify;\">\n<li>The amendment provides that a person making an application for registration shall on or before the 30th November, 2021, submit an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022.<\/li>\n<li>A provisional registration number shall be generated which will remain valid up to the May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Objections and suggestions, received from any person within 7 days will be considered by the Central Government.<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p><span style=\"color: #0000ff;\">*Tanvi Singh, Editorial Assistant has reported this brief.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health and Family Welfare has notified the Draft Medical Devices (Amendment) Rules, 2021 vide notification dated October 12, 2021. <\/p>\n","protected":false},"author":67011,"featured_media":253693,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[],"class_list":["post-255758","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.4 (Yoast SEO v26.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Applicant shall submit an undertaking for registration of medical device vide Draft Medical Devices (Amendment) Rules, 2021 | 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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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 &quot;Legislation Updates&quot;","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":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":255758,"position":1},"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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The amendment also states that for certificate of\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","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\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":263113,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/03\/08\/draft-notification-issued-for-validity-of-fitness-certificate-and-registration-mark-of-the-motor-vehicle-to-be-exhibited-on-the-vehicles\/","url_meta":{"origin":255758,"position":4},"title":"Draft Motor Vehicles (Registration and Functions of Vehicle Scrapping Facility Amendment) Rules, 2022","author":"Bhumika Indulia","date":"March 8, 2022","format":false,"excerpt":"On March 04, 2022, the Ministry of Road Transports and Highways (MoRTH) has issued the draft Motor Vehicles (Registration and Functions of Vehicle Scrapping Facility Amendment) Rules, 2022 to further amend the Motor Vehicles (Registration and Functions of Vehicle Scrapping Facility) Rules, 2021. Key Highlights: Provision for vehicle owners to\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","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\/08\/MicrosoftTeams-image-177.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-177.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-177.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-177.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-177.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":273954,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/09\/17\/comprehensive-reforms-in-the-trade-certificate-regime-vide-central-motor-vehicles-fifteenth-amendment-rules-2022\/","url_meta":{"origin":255758,"position":5},"title":"Comprehensive reforms in the Trade Certificate regime vide Central Motor Vehicles (Fifteenth Amendment) Rules, 2022","author":"Bhumika Indulia","date":"September 17, 2022","format":false,"excerpt":"\u00a0 \u00a0 The Central Government has notified Central Motor Vehicles (Fifteenth Amendment) Rules, 2022 in order to amend the Central Motor Vehicles Rules, 1989 and to simplify and streamline the Trade Certificate regime. It will come into effect from 01-11-2022. 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