{"id":50362,"date":"2022-10-27T16:03:34","date_gmt":"2022-10-27T10:33:34","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50362"},"modified":"2022-10-27T16:04:54","modified_gmt":"2022-10-27T10:34:54","slug":"medical-devices-fifth-amendment-rules-2022","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/medical-devices-fifth-amendment-rules-2022\/","title":{"rendered":"Medical Devices (Fifth Amendment) Rules, 2022- A Detailed Analysis"},"content":{"rendered":"\n<p>The Ministry of\nHealth &amp; Family Welfare (MoHFW) issued GSR 754 (E) on 30<sup>th<\/sup>\nSeptember 2022, notifying about the Medical Devices (Fifth Amendment) Rules,\n2022. A Draft for the same was issued in notification number G.S.R. 104(E) on\n9th February 2022, which has further been finalized as \u201cMedical Devices (Fifth\nAmendment) Rules, 2022\u201d. The Fifth Amendment informs about the provisions\nrelated to <strong>the sale, exhibit, offer, or\nstock for sale or distribution of medical devices, including <em>in-Vitro<\/em> diagnostic medical devices<\/strong>\nin India. <\/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-fifth-amendment-rules-2022\/#Overview_of_Medical_Device_Rules_2017\" >Overview of 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-fifth-amendment-rules-2022\/#Application_and_Registration_certificate_of_Medical_Devices\" >Application and Registration certificate of Medical Devices<\/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-fifth-amendment-rules-2022\/#Documents_required_along_with_the_Application_form\" >Documents required along with the Application form<\/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-fifth-amendment-rules-2022\/#Conditions_of_registration_related_to_Medical_Devices\" >Conditions of registration related to Medical Devices<\/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-fifth-amendment-rules-2022\/#Registration_Certificate_Validity\" >Registration Certificate Validity<\/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-fifth-amendment-rules-2022\/#Suspension_and_Cancellation_of_Registration_certificate\" >Suspension and Cancellation of Registration certificate<\/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-fifth-amendment-rules-2022\/#Forms_Included_in_the_new_amendment\" >Forms Included in the new amendment.<\/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-fifth-amendment-rules-2022\/#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><strong>Overview of Medical Device Rules, 2017<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Central Drug\nStandard Control Organization (CDSCO) is the National Regulatory Authority of\nIndia. It checks regulations and rules related to Medical Devices, Drugs and\nI.V.D.s from time to time. It also provides license and registration\ncertificate manufacturing, importing, and conducting clinical investigations\nand trials. The Medical device rules, 2017 has also classified medical devices\nbased on the risk involved along with every device, which is listed as follows-<\/p>\n\n\n\n<ul><li>Class A &#8211; Medical Devices with\nLow Risk<\/li><li>Class B &#8211; Medical Devices with\nLow- Medium Risk<\/li><li>Class C &#8211; Medical Devices with\nMedium-High Risk<\/li><li>Class D &#8211; Medical Devices with\nHigh Risk<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_and_Registration_certificate_of_Medical_Devices\"><\/span><strong>Application and Registration certificate of Medical Devices <\/strong><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 class=\"text-primary\" href=\"https:\/\/www.mohfw.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup> notified the Medical Devices (Fifth Amendment) Rules, 2022, on 30<sup>th<\/sup> September 2022 to further amend the Medical Device Rules (MDR), 2017. The Fifth Amendment informed about regulations concerning the registration of medical devices, including in vitro diagnostic medical devices to sale, exhibit, offer or stock for sale or distribution in India. The Amendments have been made in the Medical Devices (Fifth Amendment) Rules, 2022, in which new rules have been Inserted after rule 87, which are as follows- <\/p>\n\n\n\n<p><strong>Rule 87 A <\/strong>&#8211;<strong> &#8220;Registration certificate to sell,\nstock, exhibit\/offer for sale\/distribute a medical device including in-vitro\ndiagnostic medical device&#8221;<\/strong><\/p>\n\n\n\n<p>Under this rule,\nthe State Licensing Authority is authorized to appoint licensing authorities to\nissue medical device registration certificates. A person who intends to sell,\nstock, offer or exhibit any medical device including in vitro diagnostic\nmedical device, for sale or distribution must apply for the same in <strong>Form MD-41<\/strong> to the State Licensing\nAuthority to obtain the registration certificate for the same. <\/p>\n\n\n\n<p>If the State\nLicensing Authority is satisfied after verifying the documents and compliances,\nit will grant the registration certificate in <strong>Form MD-42<\/strong>. Suppose State Licensing Authority is not satisfied with\nthe submitted documents. In that case, it may reject the application, along\nwith the reasons for doing so in writing, within ten days of the date of\napplication.<\/p>\n\n\n\n<p>If the\napplication gets rejected, the applicant may also file an appeal before the\nState Government within 45 days from the date of the rejection. The applicant\nwill then be given a chance to be heard &amp; the case shall be disposed of\nwithin sixty days of such appeal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_along_with_the_Application_form\"><\/span><strong>Documents required along with the Application form <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Medical\nDevices (Fifth Amendment) Rules, 2022, informs about the <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">registration process of medical devices<\/a><\/strong>,\nincluding in-vitro medical devices. The new rules have introduced a provision\nthat the following vital documents must accompany the application form MD-41- <\/p>\n\n\n\n<ol><li>Feed specified in Second Schedule<\/li><li>Self-certificate of compliance concerning Good Distribution Compliance<\/li><li>Information related to the firm, such as its constitution, I.D. proof such as Aadhar Card or P.A.N. Card <\/li><li>Documentary evidence pertaining to ownership or occupancy, or rental of the premises <\/li><li>Information regarding the competent technical staff, which directs and supervises the sales activity of Medical Devices. The competent technical staff must hold the following qualification and experience-<ul><li>A degree from a recognized university or Institution<\/li><li>They must be a registered pharmacist<\/li><li>They must have passed the intermediate or equivalent examination from a recognized board with 1 year of experience in dealing with the sale of Medical Devices.<\/li><\/ul><\/li><li>Short description of other activities carried out by the applicant, such as storage of drugs, food products, medical items, stationery, etc. or any other activity carried out by the applicant on the premises.<\/li><li>An undertaking that all the storage requirements to sell, stock, exhibit\/offer for sale or distribution of a medical device shall be in compliance <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_of_registration_related_to_Medical_Devices\"><\/span><strong>Conditions of registration related to Medical Devices<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>87B. Conditions of Registration Certificate to sell,\nstock, exhibit\/offer for sale\/distribute a medical device comprising in-vitro\ndiagnostic medical device<\/strong><\/p>\n\n\n\n<p>The Medical\nDevices (Fifth Amendment) Rules, 2022 have laid down certain conditions for\nobtaining the registration certificate, which is as follows-<\/p>\n\n\n\n<ol><li>The registration certificate,\ngranted under rule 87A, must be displayed in a prominent space in the\nworkplace, which is easily visible to the public.<\/li><li>The certificate holder must\nprovide enough space and proper conditions for storing the medical devices.<\/li><li>The certificate holder must\nmaintain the requisite temperature and lighting according to the requirements\nof the medical device.<\/li><li>The medical devices shall be\npurchased from a licensed manufacturer or importer only.<\/li><li>Separate records in the form of\nregisters, invoices or electronic details such as software for the sale and\npurchases of a medical device shall be maintained. The details such as name,\nquantity, name and address of the manufacturer or importer, batch number or lot\nnumber and manufacturer expiry date must also be visible on the device. <\/li><li>The Medical Device Officer can\ninspect and enquire about purchases and sales of medical devices, and he can\nalso take samples for tests. <\/li><li>All the registers and records\nshall be kept safe for a minimum of two years from the last entry.<\/li><li>The registration holder must\nmaintain an inspection book in <strong>Form\nMD-43<\/strong> to allow the Medical Device Officer to note his observations and\nfeedback on the inspection.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registration_Certificate_Validity\"><\/span><strong>Registration Certificate Validity <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to <strong>Rule 87<\/strong> C of the Medical Devices (Fifth\nAmendment) Rules, 2022, the valid registration certificate issued in Form <strong>MD-42<\/strong> shall be valid for perpetuity,\nwhich is subject to payment of the retention fee as mentioned in the second\nschedule, before five years from the date of issue, unless the certificate is\nsuspended or cancelled by the State Licensing Authority.<\/p>\n\n\n\n<p>If the\ncertificate holder fails to pay the registration fees before the due date, he\nwill be liable to pay late fees at the rate of two per cent of the fees for\nevery month for a total of six months, along with the original fees. In case of\nnon-payment of such fees within the given period, the registration certificate\nshall be cancelled.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Suspension_and_Cancellation_of_Registration_certificate\"><\/span><strong>Suspension and Cancellation of Registration certificate <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Rule 87D<\/strong>, which has been\nincluded in the Medical Devices (Fifth Amendment) Rules, 2022, gives\ninformation about the suspension and cancellation of the registration\ncertificate. If the certificate holder contravenes any provisions of the rules,\nthen the State Licensing Authority, after giving the certificate holder a\nchance to show why the order shall not be made, pass an order in writing by\nproviding reasons for cancellation or suspension of the license. <\/p>\n\n\n\n<p>The registration\ncertificate holder may file an appeal for the same within forty-five days of\nsuch order. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_Included_in_the_new_amendment\"><\/span><strong>Forms Included in the new amendment.<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Medical\nDevices (Fifth Amendment) Rules, 2022 has also included some forms for the\nregulations related to the registration of medical devices comprising in-vitro\ndiagnostic medical devices, which are mentioned as follows-<\/p>\n\n\n\n<p><strong>Form MD-41<\/strong>:&nbsp; Application for the grant of Registration\nCertificate to sell, stock, exhibit\/offer for sale\/distribute a medical device\ncomprising in-vitro diagnostic medical device<\/p>\n\n\n\n<p><strong>Form MD-42<\/strong>: Registration\ncertificate to sell, stock, exhibit\/offer for sale\/distribute a medical device,\nincluding in-vitro diagnostic medical device.<\/p>\n\n\n\n<p><strong>Form MD-43: <\/strong>Form in which\nthe Inspection Book shall be maintained<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Medical Devices (Fifth Amendment) Rules, 2022, which amend the Medical Devices Rules, 2017, were notified by the Central Government on 30th September 2022, following consultation with the Drugs Technical Advisory Board. According to the rules, any person who does not have a licence but plans to sell medical device exclusively must obtain a registration certificate. The registration process can become complex when it comes to rules and regulations. Therefore, it is always advisable to seek the assistance of experts and professionals to prevent any money, energy, or time losses.<\/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\/how-to-get-medical-device-manufacturing-license-in-india\/\">How to Get Medical Device Manufacturing License in India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Health &amp; Family Welfare (MoHFW) issued GSR 754 (E) on 30th September 2022, notifying about the Medical Devices (Fifth Amendment) Rules, 2022. A Draft for the same was issued in notification number G.S.R. 104(E) on 9th February 2022, which has further been finalized as \u201cMedical Devices (Fifth Amendment) Rules, 2022\u201d. The Fifth [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50363,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2653,2808],"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":6866,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50362"}],"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=50362"}],"version-history":[{"count":2,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50362\/revisions"}],"predecessor-version":[{"id":50365,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50362\/revisions\/50365"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50363"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}