Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.
More Singapore remains one of the most important medical device hubs in the Asian region, growing to be on par with developed first world nations. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a MedTech Giant in Asia and how you shouldn’t miss out on the great business opportunities it offers.
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HSA announces a provisional authorization route for devices that decontaminate single use respirators used for COVID – 19 response. In addition, guidelines for healthcare institutions and other facilities that decontaminate respirators have also been published.
More Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.
More Health Sciences Authority (HSA) strengthens surveillance on different selling platforms to monitor health products with misleading claims to prevent, treat or diagnose COVID-19.; Warnings Issued to Over 1,600 Individual Sellers and Companies. HSA also urges public to be vigilant to report these products.
More Health Sciences Authority (HSA) ensure the availability of respiratory devices for COVID – 19 patients. HSA placed flexible regulations such as allowing the use of emergency ventilators, clarifying the applicable change notification category that will not require approval and demonstrating the means for adding new model of respiratory devices.
More Health Sciences Authority (HSA) ensures the availability of test kits for the detection and diagnosis of COVID – 19. For these devices, a provisional authorization process is implemented, which can be done via email and be responded by HSA within three (3) working days.
More The Health Sciences Authority (HSA) of Singapore has published an updated GN – 21 R4.6: Guidance on Change Notification last February 2020, effectively renaming it to GN – 21 R4.7.
More The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.
More HSA released a draft guidance for software regulation last December 2019. The draft includes detailed explanation of regulation from pre-marketing approval to post market monitoring of software devices. The Singaporean authority would like to ask for stakeholder comments before official implementation
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