{"id":30369,"date":"2023-09-18T09:20:25","date_gmt":"2023-09-18T13:20:25","guid":{"rendered":"https:\/\/platohealth.ai\/hsa-guidance-on-product-registration-submissions-documentation-regdesk\/"},"modified":"2023-09-18T10:47:48","modified_gmt":"2023-09-18T14:47:48","slug":"hsa-guidance-on-product-registration-submissions-documentation-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/hsa-guidance-on-product-registration-submissions-documentation-regdesk\/","title":{"rendered":"HSA Guidance on Product Registration Submissions: Documentation – RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to the applicable standards. <\/span><\/p>\n<\/div><\/div>\n <\/div>\n <\/p>\n <\/div>\n <\/p>\n <\/p>\n The Health Sciences Authority<\/a> (HSA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to product registration submissions. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith. <\/span><\/p>\n At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/span><\/p>\n The document describes, inter alia, the content of the submissions and outlines the key elements to be included in order to ensure the completeness and accuracy of the information submitted. <\/span><\/p>\n<\/div><\/div>\n <\/div>\n <\/div>\n <\/p>\n According to the document, it <\/span>is intended to provide guidance on the submission of a product registration dossier to HSA via the Medocumentation, Information, and Communication System (MEDICS). <\/span><\/i>In particular, the document provides clarifications with respect to specific modules to be used. <\/span><\/p>\n Under the general rule, the applications for product registration should be submitted online in electronic format in accordance with the ASEAN Common Submission Dossier Template (CSDT) or in line with the recommendations developed by the International Medical Device Regulators Forum (IMDRF) for general medical devices. <\/span><\/p>\n<\/div><\/div>\n <\/p>\n First of all, the document describes the scope of information the authority expects to be included in the submission with respect to the medical device in question. According to the guidance, the submission should include the following elements:<\/span><\/p>\n <\/i>A list of all materials in direct or indirect contact with the patient or use. <\/span><\/i>The authority additionally emphasizes that in the event of specific concerns with respect to the safety of the materials used, the HSA may request additional information be provided by the manufacturer to address such concerns. <\/span><\/p>\n<\/div><\/div>\n <\/p>\n The guidance also outlines the scope of documents to be included in the submission with respect to design verification and validation-related matters. In particular, the documentation to be provided by the applicant should cover such aspects as:<\/span><\/p>\n The authority also expects the applicants to provide comprehensive information about shelf-life studies and the projected useful life of the product in question. <\/span><\/p>\n As further explained by the HSA, the documents to be included in the submission should include sufficient evidence supporting the physical or mechanical properties of the product in question, as well as evidence supporting its electrical safety and electromagnetic compatibility. For instance, should the device be supposed to be compliant with the specifications set forth by the applicable international standard, the manufacturer will be expected to provide a summary of the appropriate test reports and\/or relevant certificates demonstrating compliance with the said specifications. <\/span><\/p>\n The manufacturer should also provide the details on the exact version of the software used for the device subject to review (the authority mentions that the version number used for internal purposes is not required). The manufacturer should also provide a description of any and all verification, validation, and testing activities carried out with respect to the software, including references to the specific version undergoing such testing. <\/p>\n The scope of the information and documentation to be submitted by the applicant should cover, inter alia, the following aspects:<\/span><\/p>\n In summary, the present HSA guidance describes in detail the scope of information and documentation to be included in the submissions in order to ensure its completeness. The authority outlines specific documents to be provided with respect to the general description of the device, its compliance with the applicable regulatory requirements and standards, as well as any testing it was subject to. <\/span><\/p>\n<\/div><\/div>\n <\/p>\n https:\/\/www.hsa.gov.sg\/docs\/default-source\/hprg-mdb\/guidance-documents-for-medical-devices\/e-submission-guide-r2-for-general-medical-devices-for-asean-csdt-and-imdrf-toc-based-submissions-in-medics-(2023-jul)-pub.pdf <\/a><\/p>\n<\/div><\/div>\n <\/div>\n <\/div>\n <\/p>\n RegDesk 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 new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to the applicable standards. Table of Contents The Health Sciences Authority (HSA), an Australian regulating […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":30375,"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\/30369"}],"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=30369"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/30369\/revisions"}],"predecessor-version":[{"id":30374,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/30369\/revisions\/30374"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/30375"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=30369"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=30369"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=30369"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span> <\/div>\n<\/p><\/div>\n
<\/span>Table of Contents<\/span><\/h2>\n<\/div><\/div>\n
<\/span>Regulatory Background<\/span><\/h2>\n
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<\/span>Device Description<\/span><\/span><\/h2>\n
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<\/span>Design Verification and Validation <\/span><\/h2>\n
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<\/span>Sources<\/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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