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Special Access Routes (SAR)

In specific situations, HSA may allow the import and the supply of unregistered medical devices via approval of Special Access Routes.

Import for re-export of unregistered devices Dealers intending to import unregistered medical devices for re-export will require approval from us. Unregistered devices for non-clinical purposes Dealers who intend to import or manufacture to supply unregistered medical devices for non-clinical purposes will require approval from us. Registered medical devices on consignment basis Dealers not authorised by the registrant, who want to import registered medical devices on consignment will require approval from us. Unregistered devices requested by qualified practitioners The import and supply unregistered devices at the request of qualified practitioners for use on their patients will require approval from us. Unregistered devices requested by licensed PHMC PHMC Act licensed laboratories and medical facilities who import and supply unregistered devices for use on their patients will require approval from us. Custom-made medical devices Custom-made medical devices do not need registration if they meet the criteria. Dealers need to update us on their list of custom-made devices. Import of unregistered medical devices for exhibition You need to seek approval from us before importing an unregistered medical device into Singapore for display at an exhibition. Import of unregistered pre-owned devices from maintenance/repair The import and supply of unregistered pre-owned devices by local facility that have been sent overseas for maintenance / repair. PSAR for Supply of Emergency Medical Devices This interim authorization enables regulatory agility in responding to an emergency that may pose serious threat to the public, such as in the situation of a pandemic.
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