{"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":"
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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

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

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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>
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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

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<\/span>Overview of Regulatory Controls<\/span><\/h2>\n

According to the guidance, the authority implements risk-adjusted regulatory controls, ensuring that all medical devices meet stringent safety and efficacy standards. <\/span>
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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

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

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<\/span>Class A Medical Devices: Exemptions<\/span><\/h2>\n

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

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  1. Registration Exemption and Regulatory Compliance<\/b> While Class A medical devices are exempt from the registration requirement, they must still adhere to the Essential Principles for Safety and Performance as outlined in the Regulations. <\/span>
    <\/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

    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>
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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

    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

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    <\/span>Special Considerations for Emerging Technologies<\/span><\/h2>\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