Special Access Routes
What are Special Access Routes?
Special Access Routes (SARs) allow unregistered medical devices to be supplied in Singapore under specific, limited circumstances where the normal product registration pathway is not applicable or practical. SARs are exceptions — not alternatives — to the standard registration pathway.
Available routes
Unregistered devices requested by a qualified practitioner
A licensed medical, dental, or other qualified practitioner may apply to import an unregistered device for a specific patient under their care. This pathway is intended for individual patient use, not for general commercial supply.
hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request
Unregistered devices requested by a licensed healthcare facility
A licensed healthcare institution (hospital, clinic, etc.) may apply to import unregistered devices for use within that institution for patient care purposes.
hsa.gov.sg/medical-devices/registration/special-access-routes/phmc-request
Import for re-export of unregistered devices
Allows unregistered devices to be imported into Singapore solely for the purpose of re-export to another market. The devices must not be supplied in Singapore.
hsa.gov.sg/medical-devices/registration/special-access-routes/export
Registered devices on consignment basis
Allows registered devices to be imported on a consignment basis before the dealer's licence is in place, under specific conditions.
hsa.gov.sg/medical-devices/registration/special-access-routes/consignment-registered
Import for exhibition
Allows unregistered devices to be imported for the purpose of display or demonstration at exhibitions, without supply for patient use.
hsa.gov.sg/medical-devices/registration/special-access-routes/import-unregistered-devices-exhibition
Unregistered pre-owned devices returned from maintenance/repair
A specific route for unregistered pre-owned devices being returned to Singapore after maintenance or repair overseas.
Pandemic SAR (PSAR-MD)
During public health emergencies, HSA may activate the Pandemic Special Access Route for emergency supply of medical devices that are not yet registered in Singapore.
hsa.gov.sg/medical-devices/registration/special-access-routes/PSAR-MD