{"id":253394,"date":"2023-11-03T07:26:53","date_gmt":"2023-11-03T11:26:53","guid":{"rendered":"https:\/\/platohealth.ai\/eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk\/"},"modified":"2023-11-03T14:43:23","modified_gmt":"2023-11-03T18:43:23","slug":"eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk\/","title":{"rendered":"EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users – RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. <\/span><\/p>\n<\/div><\/div>\n <\/div>\n <\/p>\n <\/div>\n <\/p>\n <\/p>\n The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. <\/span><\/p>\n The <\/span>Egyptian Drug Authority<\/span><\/a> (EDA), the country\u2019s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to detecting and reporting adverse reactions to drugs and medical devices. <\/span><\/p>\n The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by manufacturers, distributors, and other parties involved in order to ensure continuous safety of healthcare products allowed for marketing and use in the country. <\/span><\/p>\n The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/span><\/p>\n The scope of the guidance covers, inter alia, the aspects related to the responsibilities of users.<\/span><\/p>\n<\/div><\/div>\n <\/div>\n <\/div>\n <\/p>\n First of all, the authority emphasizes that the Vigilance System, designed to monitor and address potential issues with medical devices, heavily relies on the active participation of users. According to the guidance, this includes:<\/span><\/p>\n Thus, according to the document, building a strong relationship between the manufacturer and the user is essential to foster increased user involvement.<\/span><\/p>\n The Medical Device Safety Unit (MDSU) further plays a supportive role by offering guidance that supports user participation.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n The document further provides detailed guidelines on incident reporting to be followed in order to ensure adverse events are duly notified. <\/span><\/p>\n An adverse incident is any event where a medical device could potentially, or has, caused harm, including a serious health issue. Such incidents necessitate prompt reporting to the MDSU\/EDA.<\/span><\/p>\n The key aspects of this reporting process include:<\/span><\/p>\n <\/p>\n The document also provides general guidelines on field safety corrective actions in the part they apply to users.<\/span> In accordance with the applicable legislation, FSCAs are remedial actions initiated by manufacturers to address risks associated with devices already in circulation. These actions can vary significantly, including:<\/span> <\/p>\n In summary, the present EDA guidance describes in detail the approach to be applied by users with respect to various regulatory procedures associated with reporting adverse events and mitigating consequences thereof. <\/span> <\/p>\n https:\/\/www.edaegypt.gov.eg\/media\/kxgjqydy\/edrex-gl-cap-care-014-egyptian-guidelines-for-detecting-reporting-of-adverse-reactions-for-pharmaceutical-products-and-medical-devices-2023_1.pdf<\/a><\/p>\n<\/div><\/div>\n <\/div>\n <\/div>\n <\/p>\n RegDesk<\/strong> is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.<\/p>\n<\/div><\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/p>\n –> <\/p>\n The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. Table of content The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. The Egyptian Drug Authority (EDA), the […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":253398,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/253394"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=253394"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/253394\/revisions"}],"predecessor-version":[{"id":253397,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/253394\/revisions\/253397"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/253398"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=253394"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=253394"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=253394"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span> <\/div>\n<\/p><\/div>\n
<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n
<\/span>User Responsibilities within the Vigilance System<\/b><\/span><\/h2>\n
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\n<\/span><\/li>\n<\/span> <\/div>\n
<\/span>Detailed Adverse Incident Reporting Guidance<\/b><\/span><\/h2>\n
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<\/span>Field Safety Corrective Actions (FSCA) Guidance<\/b><\/span><\/h2>\n
<\/span><\/p>\n
<\/span><\/p>\n\n
<\/span>Conclusion<\/b><\/span><\/h2>\n
<\/span>
<\/span>The document provides precise guidelines users should follow to a letter in order to ensure the safety, as well as proper communication of information related to the respective issues. <\/span><\/p>\n<\/div><\/div>\n<\/span>Source<\/span><\/h2>\n
<\/span>How Can RegDesk Help?<\/span><\/h2>\n
Want to know more about our solutions? Speak to a RegDesk Expert today! <\/h5>\n
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