{"id":49074,"date":"2022-09-21T17:46:44","date_gmt":"2022-09-21T12:16:44","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49074"},"modified":"2022-09-21T17:46:46","modified_gmt":"2022-09-21T12:16:46","slug":"draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/","title":{"rendered":"Draft Amendment on Class-A Non-Sterile and Non-Measuring Medical Devices"},"content":{"rendered":"\n<p>The <strong>Ministry of Health &amp; Family Welfare<\/strong><sup><a href=\"https:\/\/www.mohfw.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> under The Government of India was notified on 20th September 2022, notifying the draft of amendments related to Medical Device Rules. The draft informs about the provisions related to registration of Class A Non-Sterile and Non-Measuring Medical Devices under the Medical Device Rules. As per the notification, a new chapter is inserted as Chapter IIIB in the rules, which regulates all non-sterile and\/or non-measuring devices classified as Class-A medical devices under the First Schedule of The Medical Device Rules.<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Overview_of_Medical_Device_Rules_2017\" >Overview of Medical Device\nRules, 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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Documents_to_be_submitted_by_the_Manufacturer_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Documents to be submitted by\nthe Manufacturer of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp;<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Documents_to_be_submitted_by_the_Importer_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Documents to be submitted by\nthe Importer of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp;<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Registration_Process_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Registration Process of Class-A\nNon-Sterile and Non-Measuring Medical Devices&nbsp;<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Essential_points_to_be_followed_by_the_Manufacturers_or_Importers\" >Essential points to be followed\nby the Manufacturers or Importers<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Rejection_and_Appeal_of_registration_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\" >Rejection and Appeal of\nregistration of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp;<\/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\/draft-amendment-on-class-a-non-sterile-and-non-measuring-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Medical_Device_Rules_2017\"><\/span>Overview of Medical Device\nRules, 2017 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a>, or The Central Drugs Standard Control Organization, is the highest regulatory body in India that keeps a check on rules and regulations related to Medical Devices. CDSCO is responsible for approving licenses to manufacture and Import medical devices in India. To regulate the Import, sale, distribution, manufacture, clinical trials etc., the CDSCO has notified Medical Device Rules, 2017. The medical devices have also been classified into four classes according to the risk associated with each device. The risk-based classification of medical devices is as follows-<\/p>\n\n\n\n<ul><li>Class A- Low-Risk Devices<\/li><li>Class B- Low- Medium Risk Devices <\/li><li>Class C- Medium- High-Risk Devices <\/li><li>Class D- High-Risk Devices&nbsp; <\/li><\/ul>\n\n\n\n<p>The Rules have\nbeen subject to various amendments till now. The ministry of health and family\nwelfare issued another draft for amendment on 20th September 2022, which\nregulates the provisions for registration of Class-A Non-sterile and non-\nmeasuring medical devices and has inserted a new chapter as Chapter IIIB.<\/p>\n\n\n\n<p>The new rules\ninserted under Chapter IIIB of the Medical Devices (\u2026 Amendment) Rules, 2022,\nshall be applicable for the registration of Class-A Non-Sterile and\nNon-Measuring Medical Devices as per Schedule I of the Medical Device Rules,\n2017. The registration shall be done through an Identified Online Portal for\nthe same purpose. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_to_be_submitted_by_the_Manufacturer_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Documents to be submitted by\nthe Manufacturer of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp; <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents\nwhich are to be uploaded on the portal of &#8220;Online System for Medical\nDevices&#8221; by the Manufacturer of Class-A Non-Sterile and Non-Measuring Medical\nDevices are as follows-<\/p>\n\n\n\n<ol><li>Name and Address of the manufacturing site<\/li><li>Details of the medical device, such as-<ul><li>Generic Name <\/li><li>Brand Name ( If the device is registered under Trade Marks Act, 1999) <\/li><li>Model no. (If any) <\/li><li>Intended use <\/li><li>Material of Construction<\/li><li>Dimension (If applicable) <\/li><li>Shelf life ( If applicable) <\/li><\/ul><\/li><li>Undertaking from the manufacturer that the proposed medical device is a Class A medical device (non-sterile and\/or non-measuring), according to Schedule I of the medical device rules, 2017.<\/li><li>Self- certification from the manufacturer stating that the medical device conforms to the essential principles checklist of safety and performance of the device<\/li><li>Self-certification from the manufacturer states that the medical device complies with the standards prescribed in the medical device rules, 2017.<\/li><li>Undertaking signed by the manufacturer stating that the information furnished by the applicant is genuine and authentic.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_to_be_submitted_by_the_Importer_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Documents to be submitted by\nthe Importer of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp; <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents\nwhich are to be uploaded by the Importer of Class-A Non-Sterile and\nNon-Measuring Medical Devices on the portal of &#8220;Online System for Medical\nDevices&#8221; are as follows-<\/p>\n\n\n\n<ol><li>Name and Address of the Importer and the manufacturing site<\/li><li>Details of the medical device, such as-<ul><li>Generic Name <\/li><li>Brand Name ( If the device is registered under Trade Marks Act, 1999) <\/li><li>Model no. (If any) <\/li><li>Intended use <\/li><li>Material of Construction<\/li><li>Dimension (If applicable) <\/li><li>Shelf life ( If applicable) <\/li><\/ul><\/li><li>Undertaking from the importer that the proposed medical device is a Class A medical device (non-sterile and non-measuring), according to Schedule I of the medical device rules, 2017.<\/li><li>Self- certification from the importer stating that the medical device conforms to the essential principles checklist of safety and performance of the device<\/li><li>Self- certification from the importer stating that the medical device complies with the standards prescribed in the medical device rules, 2017.<\/li><li>Self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin, issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority.<\/li><li>Undertaking signed by the importer stating that the information furnished by the applicant is authentic.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registration_Process_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Registration Process of Class-A\nNon-Sterile and Non-Measuring Medical Devices&nbsp;\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to\nRule 19H of Chapter IIIB of the Medical Devices (\u2026 Amendment) Rules, 2022, the\nmanufacturer or Importer of Class A medical devices, including Non-Sterile\nand\/or Non-Measuring medical devices, is required to obtain a registration from\nCDSCO. The manufacturer or importer must upload certain documents on the\n&#8220;Online System for Medical Devices&#8221;. After furnishing the information\nuploaded on the &#8220;Online System for Medical Devices&#8221;, the registration\nnumber for the medical device will be generated. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Essential_points_to_be_followed_by_the_Manufacturers_or_Importers\"><\/span>Essential points to be followed\nby the Manufacturers or Importers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>While obtaining\nregistration for Class-A Non-Sterile and Non-Measuring Medical Devices, there\nare some Essential points to be followed by the Manufacturers or Importers,\nwhich are as follows- <\/p>\n\n\n\n<ul><li>The manufacturer\/importer is required to\nmaintain the records of manufacturing or import along with the record of sales\nor distribution. <\/li><li>On request by Licensing Authorities, the\nmanufacturer or importer is required to produce the records, Instructions and\nlabels. <\/li><li>The Licensing Authorities may verify the\ndocuments or records at any time to investigate the quality or safety-related\nfailures or complaints.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Rejection_and_Appeal_of_registration_of_Class-A_Non-Sterile_and_Non-Measuring_Medical_Devices\"><\/span>Rejection and Appeal of\nregistration of Class-A Non-Sterile and Non-Measuring Medical Devices&nbsp; <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The State\nLicensing Authority\/Central Licensing Authority may cancel or suspend the\nregistration number for a certain period after allowing the registrant to show\nwhy the registration should not be rejected or suspended. This may happen if\nthe registrant fails to comply with any rules or requirements.<\/p>\n\n\n\n<p>The aggrieved\nperson or individual may file an appeal to the State Government or the Central\nGovernment within forty-five days of the past order. The State Government or\nthe Central Government then may pass an order to confirm, modify or reverse\nsuch order if satisfied by the appellant. <\/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 draft issued by The Ministry of Health And Family Welfare under The Government of India is yet to be finalised after receiving objections and suggestions from any person who may be affected by the amendment. The regulation related to the registration of Class-A Non-Sterile and Non-Measuring Medical Devices has been introduced under the draft. The draft introducing certain rules to amend the medical device rules, 2017 is called Medical Devices (&#8230;&#8230;&#8230;Amendment) Rules, 2022. Under this, any manufacturer or importer of Class-A Non-Sterile and Non-Measuring medical devices must obtain registration for their individual purpose.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/application-procedure-for-class-a-and-b-medical-devices\/\">Application Procedure for Class A and B Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health &amp; Family Welfare[1] under The Government of India was notified on 20th September 2022, notifying the draft of amendments related to Medical Device Rules. The draft informs about the provisions related to registration of Class A Non-Sterile and Non-Measuring Medical Devices under the Medical Device Rules. As per the notification, a [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":49083,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2733],"acf":{"service_id":"508"},"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":3550,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49074"}],"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=49074"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49074\/revisions"}],"predecessor-version":[{"id":49086,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49074\/revisions\/49086"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49083"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}