The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the upcoming Phase 2 – UDI Implementation, effective starting from 1 November 2024, involving all general medical devices under Class D and In Vitro Diagnostic (IVD).
Class D medical devices consisted of high-risk devices, for example, implantable defibrillators, pacemakers, and heart stents. Registrants were advised to voluntarily update all UDI-related data in the Medical Device Information and Communication System (MEDICS) before the compliance date, to facilitate and ensure a smooth transition period.
All medical devices are compulsory to be registered with HSA before the product placement in Singapore. While medical devices that are supplied after the compliance date for each risk class, are compulsory to comply with the UDI requirements. Six (6) six-month transition period is provided from the compliance date to facilitate companies with products that have been imported and exist in the current supply chain.
Source: Health Sciences Authority (HSA)
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