{"id":50332,"date":"2022-10-26T12:30:07","date_gmt":"2022-10-26T07:00:07","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50332"},"modified":"2022-10-26T12:30:09","modified_gmt":"2022-10-26T07:00:09","slug":"medical-devices-sixth-amendment-rules-2022","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/","title":{"rendered":"Medical Devices (Sixth Amendment) Rules, 2022 &#8211; A Detailed Analysis"},"content":{"rendered":"\n<p>The Ministry of\nHealth and Family Welfare or MoHFW notified G.S.R. 777 (E) on 14<sup>th<\/sup>\nOctober 2022, Notifying about the Medical Devices (Sixth Amendment) Rules, 2022.\nA draft for the same was issued in notification no. G.S.R. 710(E) on 20<sup>th<\/sup>\nSeptember 2022, which this notification has further finalised as \u201cMedical\nDevices (Sixth Amendment) Rules, 2022\u201d. The Amendment informs about the\nprovisions related to <strong>the Registration of\nClass A (Non-Sterile and Non-Measuring) Medical Devices<\/strong> under the Medical\nDevice Rules 2017.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Overview_of_the_Medical_Device_Rules_2017\" >Overview of the Medical Device Rules, 2017<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Regulations_of_the_Sixth_Amendment\" >Regulations of the Sixth Amendment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Documents_required_by_Manufacturers_of_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Documents required by Manufacturers of Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Documents_required_by_Importers_of_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Documents required by Importers of Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#The_registration_number_for_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >The registration number for Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Maintenance_of_records_by_Manufacturers_and_Importers\" >Maintenance of records by Manufacturers and Importers<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Cancellation_or_Suspension_of_registration\" >Cancellation or Suspension of registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/medical-devices-sixth-amendment-rules-2022\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_the_Medical_Device_Rules_2017\"><\/span>Overview of the Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drug\nStandard Control Organization (CDSCO) is the highest regulatory authority in\nIndia. It is responsible for checking medical device standards and regulating\nthem from time to time. It is accountable for granting licenses for\nmanufacturing and importing medical devices in India. Medical device rules,\n2017 have been introduced by CDSCO to regulate the regulations related to the\nmanufacture and Import of Medical devices in India. The Medical Device Rules\n2017 classifies Medical Devices into four types based on their risk\nclassification, which is listed as follows-<\/p>\n\n\n\n<ul><li>Medical Devices with Low Risk-\nClass A <\/li><li>Medical Devices with Low-\nMedium Risk- Class B <\/li><li>Medical Devices with\nMedium-High Risk- Class C <\/li><li>Medical Devices with High Risk-\nClass D <\/li><\/ul>\n\n\n\n<p>CDSCO is also\nresponsible for performing various functions to ensure that customers use good\nquality and certified medical devices. The tasks of CDSCO are as follows- <\/p>\n\n\n\n<ul><li>Medical device imports<\/li><li>Medical device manufacturing <\/li><li>Medical Device Clinical\nInvestigation<\/li><li>Approval of Investigational Medical\nDevices <\/li><li>Performing clinical tests on\nMedical devices <\/li><li>Coordination with State\nLicensing Authority (S.L.A.) <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulations_of_the_Sixth_Amendment\"><\/span>Regulations of the Sixth Amendment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Medical\nDevices (Sixth Amendment) Rules, 2022, has been notified by the Ministry of Health\nand Family Welfare, in a notification <em>vide\n<\/em>GSR 777 (E) dated 14<sup>th<\/sup> October 2022. The notification made a few\nrules to amend the Medical Device Rules 2017, under which a new chapter III B\nhas been included after rule 19 F. The Amendment also regulates provisions\nrelated to the Registration of Class A (Non- Sterile and Non-Measuring) Medical\nDevices. Seven Rules <strong>(19 G-19 M) <\/strong>have\nbeen inserted in the new amendment chapter. &nbsp;<\/p>\n\n\n\n<p>According to <strong>Rule 19-G<\/strong>, Chapter III B would apply to\nall non-sterile and non-measuring medical devices classified as Class A Medical\ndevices under Schedule I of the Medical Device Rules, 2017. The registration\nprocess for these devices shall be done through an Identified Online Portal\nmade for this purpose. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_by_Manufacturers_of_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Documents required by Manufacturers of Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to <strong>Rule 19H<\/strong> of the Medical Devices (Sixth Amendment) Rules, 2022, the manufacturer of Class A non-sterile and non-measuring medical devices must submit the required information for medical device registration through an online portal. <\/p>\n\n\n\n<p>The documents\nwhich are required to be submitted by the <strong>manufacturer<\/strong>\nare-<\/p>\n\n\n\n<ol><li>Name and Address of manufacturing site <\/li><li>Medical device details such as- <ul><li>Generic Name <\/li><li>Dimension (If applicable) <\/li><li>Model no. (If any) <\/li><li>Brand Name ( If the device is registered under Trade Marks Act, 1999) <\/li><li>Material of Construction<\/li><li>Intended use <\/li><li>Shelf life ( If applicable) <\/li><\/ul><\/li><li>The manufacturer must submit an undertaking stating that the proposed medical device is a Class A medical device (non-sterile and non-measuring) under Medical Device Rules 2017, Schedule I.<\/li><li>The manufacturer must submit a self-certification stating that the product conforms to the essential principle checklist for product safety and performance. <\/li><li>\u00a0The manufacturer must submit a self-certification stating that he will comply with the Standards specified in the Medical Device Rules, 2017. <\/li><li>The manufacturer must submit an undertaking signed by him, mentioning that the information furnished by the applicant is authentic and genuine. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_by_Importers_of_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Documents required by Importers of Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to <strong>Rule 19J<\/strong> of the Medical Devices (Sixth\nAmendment) Rules, 2022, the Importer of Class A non-sterile and non-measuring\nmedical device must submit the required information for medical device\nregistration through an online portal. <\/p>\n\n\n\n<p>The documents\nwhich are required to be submitted by the <strong>Importer<\/strong>\nare-<\/p>\n\n\n\n<ol><li>Name and Address of Importer and Manufacturing site <\/li><li>Medical device details such as- <ul><li>Generic Name <\/li><li>Dimension (If applicable) <\/li><li>Model no. (If any) <\/li><li>Brand Name ( If the device is registered under Trade Marks Act, 1999) <\/li><li>Material of Construction<\/li><li>Intended use <\/li><li>Shelf life ( If applicable) <\/li><\/ul><\/li><li>The Importer must submit an undertaking stating that the proposed medical device is a Class A medical device (non-sterile and non-measuring) under Medical Device Rules 2017, Schedule I.<\/li><li>The Importer must submit a self-certification stating that the product conforms to the essential principle checklist for product safety and performance. <\/li><li>\u00a0The Importer must submit a self-certification stating that he will comply with the Standards specified in the Medical Device Rules, 2017. <\/li><li>The Importer must submit a self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin issued by the competent authority or a Free Sale Certificate issued by the National Regulatory Authority.<\/li><li>The Importer must submit an undertaking signed by him, mentioning that the information furnished by the applicant is authentic and genuine. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_registration_number_for_Class_A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>The registration number for Class A (Non-Sterile and Non-Measuring) Medical Devices\u00a0 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Rule 19-I<\/strong> and <strong>Rule 19-K<\/strong> of Chapter IIIB of the Medical Devices (Sixth Amendment) Rules, 2022, give information about obtaining a registration number for Class A Non-Sterile and Non-Measuring medical devices by <strong>Manufacturer<\/strong> and <strong>Importer, <\/strong>respectively. The Medical Devices (Sixth Amendment) Rules, 2022 guides that the registration number shall be granted for Class A (Non-Sterile and Non-Measuring) <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Devices<\/strong><\/a> after furnishing the information submitted by the Manufacturers and Importers on the \u201cOnline system for Medical Device\u201d, which is established for the same purpose. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Maintenance_of_records_by_Manufacturers_and_Importers\"><\/span>Maintenance of records by Manufacturers and Importers <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Rule 19-L<\/strong> of the Medical\nDevices (Sixth Amendment) Rules, 2022, instructs the Manufacturer or Importer that\nthey must maintain all the records of manufacturing or import along with the\nsales and distribution. The Manufacturers or Importers must produce all the\nRecords, Instructions and Labels for use if the licensing authorities request\nso. The Licensing Authorities may also verify the records and documents to\ninvestigate quality or safety-related issues.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cancellation_or_Suspension_of_registration\"><\/span>Cancellation or Suspension of registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Rule 19-M of the <\/strong>Medical\nDevices (Sixth Amendment) Rules, 2022 provides information on the Cancellation\nor Suspension of registration of Class A (Non-Sterile and Non-Measuring)\nMedical Devices. Suppose the registration has been cancelled or suspended. In\nthat case, the State licensing Authority or Central licensing Authority must\ngive the registrant a chance to explain why the registration must not be\ncancelled or suspended. If the Authorities are not satisfied with the reasons,\nthey must pass an order in writing, mentioning the grounds for cancellation or\nSuspension of the registration. &nbsp;<\/p>\n\n\n\n<p>If a person is\naggrieved by an Order passed by the S.L.A. or C.L.A., they may file an appeal\nto the State Government or the Central Government within forty-five days of\nreceiving a copy of such order. After giving the aggrieved an opportunity to be\nheard, the government may confirm, reverse or modify such orders. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p> The Ministry of Health and Family Welfare or <strong>MoHFW<\/strong><sup><a href=\"https:\/\/www.mohfw.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> has notified Medical Devices (Sixth Amendment) Rules, 2022, in a notification GSR 777 (E) dated 14<sup>th<\/sup> October 2022. Before finalising the Amendment, the MoHW released its draft in the notification GSR 710 (E) on 20<sup>th<\/sup> September. The Medical Devices (Sixth Amendment) Rules, 2022 provides information on the rules relating to Class A (Non-Sterile and Non-Measuring) Medical Devices. The rules and regulations might get complicated to understand while obtaining the registration. It is always advisable to get assistance from experts and professionals while obtaining a medical device registration certificate.  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health and Family Welfare or MoHFW notified G.S.R. 777 (E) on 14th October 2022, Notifying about the Medical Devices (Sixth Amendment) Rules, 2022. A draft for the same was issued in notification no. G.S.R. 710(E) on 20th September 2022, which this notification has further finalised as \u201cMedical Devices (Sixth Amendment) Rules, 2022\u201d. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50339,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2805],"acf":{"service_id":"385"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":4976,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50332"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50332"}],"version-history":[{"count":13,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50332\/revisions"}],"predecessor-version":[{"id":50348,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50332\/revisions\/50348"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50339"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50332"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50332"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}