Extension of Phase 3 UDI compliance date
HSA announced that the compliance date for Phase 3 UDI implementation has been extended from 1 November 2026 to 31 December 2026. Under the revised timeline, all Class C General medical devices and IVD medical devices must be labelled with UDI prior to import and supply in Singapore from 1 January 2027.
Existing requirements for Phases 1 and 2
HSA reminded stakeholders that devices covered under earlier phases are already required to carry UDI labelling. These include coronary stents, orthopaedic joint replacement implants, intraocular lenses, and Class D General and IVD medical devices.
Responsibilities of medical device dealers
All medical device dealers, including registrants, importers, wholesalers, and manufacturers, are responsible for ensuring compliance with the applicable UDI labelling requirements. Registrants are also required to submit all required UDI information through the Singapore Health Product Access and Regulation E-System (SHARE) upon implementation.
HSA further noted that failure to comply with the applicable UDI requirements may result in regulatory action.
Implications and Significance
The extension provides stakeholders handling Class C General and IVD medical devices with additional time to prepare for Phase 3 UDI implementation. Companies should review their affected product portfolios, labelling readiness and required UDI information to ensure compliance with the revised timeline. The extension applies specifically to Phase 3 and does not change the existing UDI obligations for devices already covered under Phases 1 and 2.
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Reference
HSA industry stakeholder announcement