The Health Sciences Authority (HSA) Singapore has published the latest guidance document on special access routes (SAR), that provide a pathway for unregistered medical devices to be brought into Singapore, in April 2022.
The SAR that can be used for clinical use are GN-26 and GN-27, which are for licensed qualified practitioners and healthcare facilities licensed under the Private Hospitals and Medical Clinics Act (PHMCA) / Healthcare Services Act (HCSA) respectively.
Additionally, unregistered medical devices of Class C and/or D will need to be endorsed by the Chairman of Medical Board (CMB) of the Public Healthcare Institution (PHI) or equivalent. As for class D medical devices applied by PHIs, the clinical justification will need to be reviewed by the Ministry of Health (MOH).
More details can be found in “Guidance on Special Access Routes (SAR), Revision 2, April 2022”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/guidance-on-special-access-routes-(sar)-(18mar-pub).pdf