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).
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