{"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":"
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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

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<\/span>Table of Contents<\/span><\/h2>\n<\/div><\/div>\n

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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

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<\/span>Regulatory Background<\/span><\/h2>\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

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<\/span>Device Description<\/span><\/span><\/h2>\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