Special Access Routes (SAR)

Import and supply of unregistered medical devices at the request of a licensed healthcare facility

HCSA licensed laboratories and medical facilities who import and supply unregistered devices for use on their patients will require approval from us.

Import and supply of unregistered medical devices by request of qualified practitioners

The import and supply of unregistered devices at the request of a qualified practitioner for use on his patient will require approval from us.

Import and supply of unregistered medical devices for non-clinical purpose​s

Dealers who intend to import or manufacture to supply unregistered medical devices for non-clinical purposes will require approval from us.

Import for re-export of unregistered medical devices

Dealers intending to import unregistered medical devices for re-export will require approval from us.

Import of a consignment of registered medical devices

Dealers not authorised by the registrant, who want to import registered medical devices on consignment will require approval from us.

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 returned from maintenance/repair

The import and supply of unregistered pre-owned devices by local facility that have been sent overseas for maintenance / repair.

Pandemic Special Access Route (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.