On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 5 of GN-35: Guidance on Special Access Routes (SAR) for medical devices. This latest update introduces enhanced regulatory clarity and fully digitalised processes to facilitate access to unregistered medical devices in Singapore.
Scope
Summary results of the updated GN-35 guidance on Special Access Routes (SAR) issued by the HSA.
Key Points
Full Digitalisation via SHARE
- All SAR applications, including submission of declaration of distribution records, must now be submitted exclusively through the Singapore Health Product Access and Regulatory E-System (SHARE).
- This shift ensures a fully digital, standardised, and efficient submission and review process, reducing administrative burden and improving traceability.
Refined Application Requirements
- Eligibility prerequisites for GN-26 SAR applications are clarified in Table 2, Appendix 1, and Appendix 4:
- Devices must have prior approval from at least one recognised reference regulatory authority (Australia TGA, Canada HC, Japan MHLW, US FDA, or EU NB).
- Exceptions apply for compassionate use cases where the device represents the patient’s last treatment option. Such applications may proceed with documented professional consensus, in line with the Singapore Medical Council’s Ethical Code and Guidelines (Section B6, paragraph 4).
Attachment
See the full guidance document here: GN-35 Revision 5 Guidance on Special Access Routes (PDF).
Effective Date
4 September 2025
Implications to the Client
This revision promotes greater efficiency, transparency, and patient protection by digitalising the SAR process and reinforcing regulatory standards. While stakeholders may need to adjust to using SHARE, the system ultimately improves accountability and ensures timely patient access to safe, high-quality medical devices, especially in compassionate, last-resort cases.
For further assistance with navigating GN-35 or submitting SAR applications, please contact us at sales@andamanmed.com or click the button below.
