{"id":605056,"date":"2024-06-03T09:41:41","date_gmt":"2024-06-03T13:41:41","guid":{"rendered":"https:\/\/platohealth.ai\/hsa-guidance-on-medical-device-product-registration-class-a-and-b-hsa\/"},"modified":"2024-06-03T20:09:48","modified_gmt":"2024-06-04T00:09:48","slug":"hsa-guidance-on-medical-device-product-registration-class-a-and-b-hsa","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/hsa-guidance-on-medical-device-product-registration-class-a-and-b-hsa\/","title":{"rendered":"HSA Guidance on Medical Device Product Registration: Class A and B | HSA","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
The new article provides an overview of the medical device registration process in general. Also, it describes in detail the approach to be followed for registration of Class A and B products. <\/span><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p>\n \t\t\t\t <\/p><\/div>\n <\/p>\n <\/p>\n The <\/span>Health Sciences Authority <\/b><\/a>(HSA), Singapore\u2019s regulatory agency in healthcare products, has published an updated guidance document dedicated to registration of medical devices. <\/span> \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n According to the guidance, the authority implements risk-adjusted regulatory controls, ensuring that all medical devices meet stringent safety and efficacy standards. <\/span> The document further describes the regulatory requirements to be applied depending on the class of a medical device under the respective risk-based classification.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n \t\t\t\t In particular, the document describes the regulatory requirements for Class A medical devices. Due to its relatively low risks, such products could be placed on the market under a simplified procedure.<\/span><\/p>\n 2. Guidance and Oversight <\/b>To navigate the regulatory framework, the parties involved in operations with Class A medical devices can refer to the GN-22 guidance document issued earlier by the HSA.<\/p>\n The document provides valuable insights into managing exempted devices while ensuring compliance with statutory requirements. <\/span> 3. Product Registration Grouping Requirements.<\/strong> The HSA specifies grouping requirements for product registration applications to streamline the registration process. These groupings include individual devices, device families, systems, and various specific clusters. Guidance documents GN-12-1 and GN-12-2 elaborate on the criteria for each grouping, providing clarity and structure to the application process.This systematic approach facilitates efficient regulatory review by categorizing devices according to their function and use.<\/p>\n<\/div><\/div>\n <\/p>\n The document also provides additional clarifications regarding the approach to be followed concerning certain specific categories of medical devices, including the ones utilizing novel technologies.<\/span><\/p>\n <\/p>\n Apart from the aspects outlined hereinabove, the document also provides additional clarifications and recommendations regarding the approach to be followed when the product in question is a Class B medical device. <\/span><\/p>\n According to the document, for Class B medical devices, the HSA offers three evaluation routes: Full, Abridged, and Immediate Class B Registration (IBR), each tailored to leverage existing approvals from global regulatory bodies or the device\u2019s safe marketing history if it is already available. <\/span><\/p>\n The document also mentions ASEAN CSDT standardizes the submission process for Class B medical devices, underscoring the importance of a harmonized approach within the ASEAN region. <\/span> The processing of applications varies based on the evaluation route, with the IBR route offering an expedited path to market for eligible devices.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n The present HSA guidance provides a detailed overview of the regulatory requirements for placing Class A and B medical devices on the market. The document outlines the existing registration pathways to be applied. Also, it highlights the key points associated with that to facilitate the respective regulatory procedure and reduce the regulatory burden for the parties involved.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n https:\/\/www.hsa.gov.sg\/docs\/default-source\/hprg-mdb\/guidance-documents-for-medical-devices\/gn-15-r11-guidance-on-medical-device-product-registration-(2024-mar)-pub.pdf<\/a><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n RegDesk<\/strong><\/a> 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 \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p><\/div>\n \t\t<\/div>\n \n\t<\/div>\n <\/p><\/div>\n <\/p>\n –><\/p>\n The new article provides an overview of the medical device registration process in general. Also, it describes in detail the approach to be followed for registration of Class A and B products. Table of content The Health Sciences Authority (HSA), Singapore\u2019s regulatory agency in healthcare products, has published an updated guidance document dedicated to registration […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":605060,"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\/605056"}],"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=605056"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/605056\/revisions"}],"predecessor-version":[{"id":605059,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/605056\/revisions\/605059"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/605060"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=605056"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=605056"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=605056"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span>\n\t\t\t<\/div>\n<\/p><\/div>\n
<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n
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<\/span>The document describes in detail the applicable regulatory requirements. <\/span>
<\/span>Also, it provides additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with it. <\/span>
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<\/span>At the same time, provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations. <\/span>
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<\/span>The authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.<\/span><\/p>\n<\/div><\/div>\n<\/span>Overview of Regulatory Controls<\/span><\/h2>\n
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<\/span>As mentioned before, unless specifically exempted, every medical device must undergo registration with the HSA to be allowed for marketing and use in the country.<\/span><\/p>\n<\/span>\n\t\t\t<\/div>\n
<\/span>333. <\/span><\/h2>\n
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<\/span>Class A Medical Devices: Exemptions<\/span><\/h2>\n
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<\/span>This exemption introduces a regulatory strategy that balances oversight with operational efficiency, facilitating the placement of lower-risk devices in the market. <\/span>
<\/span>At the same time, the authority additionally emphasizes that the obligations under Part VIII of the Act, covering the entire lifecycle of these devices from manufacture to advertisement remain enforceable.<\/span><\/li>\n<\/ol>\n
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<\/span>In particular, it is stated that specific Class A devices intended for use within a registered medical device system are listed on the Singapore Medical Device Register (SMDR), ensuring visibility and regulatory oversight even within exempt categories. <\/span><\/p>\n<\/span>Special Considerations for Emerging Technologies<\/span><\/h2>\n
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<\/span>The HSA acknowledges the innovative manufacturing processes and customized solutions offered by 3D printing while emphasizing the importance of ensuring that these advancements do not compromise patient safety.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/span>Class B Medical Devices: Evaluation Routes and Registration<\/span><\/h2>\n
<\/span>This format facilitates the review process, ensuring all necessary documentation and data are consistently presented across applications.<\/span><\/p>\n<\/span>Conclusion<\/b><\/span><\/h2>\n
<\/span>Source<\/span><\/h2>\n
<\/span>How Can RegDesk Help?<\/span><\/h2>\n
\n\t\t\t\t\t\t\t\tWant to know more about our solutions? Speak to a RegDesk Expert today!
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