Singapore’s Health Sciences Authority (HSA) has introduced a Registration Support Initiative to help clinically important but unregistered medical devices transition from the Special Access Route (SAR) to formal registration. Published on 28 August 2026, the initiative is aimed particularly at devices serving small patient populations where limited commercial viability may have discouraged suppliers from pursuing registration. The inaugural application window remains open until 31 December 2026. HSA plans to reopen the initiative annually from 1 October to 31 December, providing a recurring route for clinicians and suppliers to propose eligible devices.

Moving Beyond the Special Access Route

Singapore’s SAR enables healthcare institutions to obtain unregistered medical devices in exceptional circumstances when required for specific clinical needs. HSA has clarified that SAR is not intended to serve as a permanent supply mechanism for devices that continue to be used in Singapore. The new initiative would support the transition of selected devices to the formal registration framework. This could provide a more sustainable supply route, particularly for low-volume devices used by small or specialised patient groups.

Evaluation-Fee Waiver

HSA will waive evaluation fees for devices that satisfy the initiative’s eligibility requirements. The waiver is intended to reduce the regulatory cost that may otherwise make registration commercially impractical for suppliers of low-volume products. The announcement does not indicate that all devices currently supplied through SAR will qualify. Product-specific eligibility must be assessed against the detailed criteria contained in HSA’s Dear Healthcare Professional Letter, which is accessible through the Ministry of Health’s Health Professionals Portal.

Clinician and Supplier Coordination

Clinicians are expected to identify potentially eligible devices used in their practice and complete a Clinical Justification and Endorsement Form. They must then connect with the relevant device supplier so that the formal registration process can be initiated. Suppliers should therefore coordinate with clinicians and healthcare institutions to document the device’s clinical importance, affected patient population and continued supply need. Foreign manufacturers will also need an appropriate Singapore regulatory arrangement, including a local registrant where required under the medical-device registration framework.

Industry Impact

The initiative could reduce long-term reliance on individual SAR applications and improve supply continuity for clinically important devices with limited Singapore market demand. Formal registration may also create a clearer and more predictable regulatory basis for continued commercial supply. Suppliers currently supporting products through SAR should review their portfolios and identify devices that may warrant clinician endorsement. Because the detailed eligibility conditions are not available on the public announcement page, companies should confirm qualification before relying on the evaluation-fee waiver.