{"id":605386,"date":"2024-06-03T09:35:54","date_gmt":"2024-06-03T13:35:54","guid":{"rendered":"https:\/\/platohealth.ai\/hsa-guidance-on-medical-device-product-registration-class-c-and-d-hsa\/"},"modified":"2024-06-04T05:09:34","modified_gmt":"2024-06-04T09:09:34","slug":"hsa-guidance-on-medical-device-product-registration-class-c-and-d-hsa","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/hsa-guidance-on-medical-device-product-registration-class-c-and-d-hsa\/","title":{"rendered":"HSA Guidance on Medical Device Product Registration: Class C and D | HSA","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The new article describes the regulatory requirements concerning high-risk products \u2013 Class C and D medical devices. <\/span><\/p>\n<\/div><\/div>\n

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\t\t\t\t\"HSA<\/span>\n\t\t\t<\/div>\n<\/p><\/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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The document describes in detail the applicable regulatory requirements. Also, it provides additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance to 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

In particular, the scope of the guidance covers the aspects related to the registration requirements to be applied to Class C and D medical devices intended to be marketed and used in the country. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Evaluation Routes<\/span><\/h2>\n

According to the guidance, Class C and D medical device registration process covers four primary evaluation routes. These routes are intended to streamline the evaluation process by offering distinct pathways tailored to various device classifications and regulatory approvals:<\/span>
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