{"id":274997,"date":"2022-10-04T15:30:33","date_gmt":"2022-10-04T10:00:33","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=274997"},"modified":"2022-10-04T15:30:33","modified_gmt":"2022-10-04T10:00:33","slug":"requirement-to-obtain-registration-certificate-to-sell-any-medical-devices-introduced-vide-medical-devices-fifth-amendment-rules-2022","status":"publish","type":"post","link":"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\/","title":{"rendered":"Requirement to obtain registration certificate to sell any medical devices introduced vide Medical Devices (Fifth Amendment) Rules, 2022"},"content":{"rendered":"<div style=\"text-align: justify; line-height: 150%;\">\n<p style=\"text-indent: 18pt;\">&#160; &#160;<\/p>\n<p style=\"text-indent: 18pt; margin-bottom: 3%;\">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 <a href=\"https:\/\/www.scconline.com\/DocumentLink.aspx?q=JTXT-0002454624\">Medical Devices Rules, 2017<\/a>. The Rules provides that any person not holding licence and intends to sell medical devices exclusively must obtain registration certificate.<\/p>\n<p><b>Key points<\/b>:<\/p>\n<ul>\n<li>\n<p>The Amendment inserts a new rule providing Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device. The registration certificate will be issued by Licensing authorities appointed by the State Licensing Authority.<\/p>\n<\/li>\n<li>\n<p>An application to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device, must be made in Form MD-41 to the State Licensing Authority for grant of registration certificate.<\/p>\n<\/li>\n<li>\n<p>The registration certificate holder must display the certificate at a prominent place in the premises visible to the public and must provide adequate space and proper storage condition for storage of the medical devices.<\/p>\n<\/li>\n<li>\n<p>All registers and records under the Rules must be preserved for a period of not less than two years from the last entry, therein.<\/p>\n<\/li>\n<li>\n<p>The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.<\/p>\n<\/li>\n<li>\n<p>A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority.<\/p>\n<\/li>\n<li>\n<p>Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause as to why such an order should not be passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the registration certificate.<\/p>\n<\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&#160; &#160; On 30-09-2022, the Central Government, after consultation with the Drugs Technical Advisory Board, notified Medical Devices (Fifth Amendment) Rules, 2022 <\/p>\n","protected":false},"author":8808,"featured_media":275011,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[9541,52171,37264,36545],"class_list":["post-274997","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-licence","tag-medical-devices","tag-ministry-of-health-and-family-welfare","tag-registration-certificate"],"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>Requirement to obtain registration certificate to sell any medical devices introduced vide Medical Devices (Fifth Amendment) Rules, 2022 | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, 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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 &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\/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":277067,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/11\/09\/legislation-monthly-roundup-october-2022-15-stories-relating-to-legal-metrology-amendment-rules-digital-media-ethics-code-amendment-rbi-credit-information-companies-internal-ombudsman-direc\/","url_meta":{"origin":274997,"position":1},"title":"[October 2022] Legislation Monthly Roundup | 15+ Stories relating to Legal Metrology Amendment Rules; Digital Media Ethics Code; RBI (Credit Information Companies- Internal Ombudsman) Directions, 2022 and SEBI Circulars","author":"Editor","date":"November 9, 2022","format":false,"excerpt":"A quick legal roundup to cover important stories from all Legislation Updates in October 2022 MINISTRY OF CORPORATE AFFAIRS Legal Metrology (General) Amendment Rules, 2022 The Central Government has notified Legal Metrology (General) Amendment Rules, 2022 to amend the Legal Metrology (General) Rules, 2011 to provide for the companies to\u2026","rel":"","context":"In &quot;Legal RoundUp&quot;","block_context":{"text":"Legal RoundUp","link":"https:\/\/www.scconline.com\/blog\/post\/category\/columns-for-roundup\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image8-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image8-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image8-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image8-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image8-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":280949,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/01\/04\/legislation-year-end-round-up-2022-quick-recap-of-all-the-important-legislations-relating-to-central-state-and-foreign-legislature\/","url_meta":{"origin":274997,"position":2},"title":"Legislation Year End Round-Up 2022 | Quick Recap of All the Important Legislations Relating to Central, State and Foreign Legislature","author":"Editor","date":"January 4, 2023","format":false,"excerpt":"\u00a0 \u00a0 January Updates: Fire Detection and Protection system in passenger compartment in buses vide Central Motor Vehicles (First Amendment) Rules, 2022 On January 27, 2022, the Ministry of Road Transport and Highways (MoRTH) has issued the Central Motor Vehicles (First Amendment) Rules, 2022 to further amend the Central Motor\u2026","rel":"","context":"In &quot;Legal RoundUp&quot;","block_context":{"text":"Legal RoundUp","link":"https:\/\/www.scconline.com\/blog\/post\/category\/columns-for-roundup\/"},"img":{"alt_text":"Legislation Year End Round-Up","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/01\/MicrosoftTeams-image140.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"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":274997,"position":3},"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. Unique device\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\/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":257901,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/11\/30\/amendment-in-drugs-rules-1945-to-omit-provisions-for-issuing-duplicate-copy-of-import-licence-and-registration-certificate\/","url_meta":{"origin":274997,"position":4},"title":"Amendment in Drugs Rules, 1945 to omit provisions for issuing duplicate copy of import licence and registration certificate","author":"Bhumika Indulia","date":"November 30, 2021","format":false,"excerpt":"The Central Government, after consultation with the Drugs Technical Advisory Board makes Drugs (6th Amendment) Rules, 2021 further to amend the Drugs Rules, 1945. They shall come into force on the date of their publication in the Official Gazette. \u00a0 Key amendments: In the Drugs Rules, 1945, in rule 24,\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":293575,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/06\/01\/legislation-roundup-may-2023-legal-update\/","url_meta":{"origin":274997,"position":5},"title":"LEGISLATION ROUNDUP- MAY: 16+ Stories on SPG for PM\u2019s Security; Type III Buses protection from fire; LG control on \u2018Services\u2019","author":"Kriti","date":"June 1, 2023","format":false,"excerpt":"MINISTRY OF CORPORATE AFFAIRS MCA tightens norms for closure of firms vide Companies (Removal of Names of Companies from the Register of Companies) Second Amendment Rules, 2023 On 10-5-2023, the Ministry of Corporate Affairs notified the Companies (Removal of Names of Companies from the Register of Companies) Second Amendment Rules,\u2026","rel":"","context":"In &quot;Legal RoundUp&quot;","block_context":{"text":"Legal RoundUp","link":"https:\/\/www.scconline.com\/blog\/post\/category\/columns-for-roundup\/"},"img":{"alt_text":"legislation roundup may 2023","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/legislation-roundup-may-2023.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/legislation-roundup-may-2023.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/legislation-roundup-may-2023.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/06\/legislation-roundup-may-2023.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/274997","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\/8808"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=274997"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/274997\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/275011"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=274997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=274997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=274997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}