Registration Support Initiative to Encourage Registration of Unregistered Medical Devices accessed through SAR
The SAR Registration Support initiative aims to encourage and facilitate the registration of unregistered medical devices that have been accessed through Special Access Route.
Last updated 28 May 2026
Registration Support Initiative to Encourage Registration of Unregistered Medical Devices accessed through Special Access Route (SAR)
Medical device registration is fundamental to patient safety, ensuring devices meet rigorous standards of safety, quality, and efficacy before market access. In exceptional circumstances, HSA permits the import and supply of unregistered medical devices under the SAR. As HSA strengthens SAR oversight and discourages repeated SAR use, companies are encouraged to register their unregistered devices formally.
To support this, HSA has introduced the SAR Registration Support Initiative - a new programme separate from existing SAR applications - to encourage and facilitate the registration of unregistered medical devices previously accessed through the SAR. This is a recurring annual exercise, with a submission window open from 1 June to 31 August each year.
The initiative addresses two key barriers to registration: medical devices supplied at low volumes and low prices, where registration costs are seen as disproportionate to the applicable evaluation fees; and legacy medical devices with a long history of clinical use, where the high costs and administrative burden of preparing registration dossiers have deterred formal registration.
Eligibility Criteria:
Unregistered medical devices that meet all the qualification criteria (Criteria A or Criteria B) will be eligible for the SAR Support Initiative.
Criteria A: Essential life-saving MDs for rare clinical situations
Medical devices that are higher risk (i.e. Class C or Class D MDs); and
Medical devices that are essential and/or life-saving in nature and are used in rare clinical situations (i.e. limited use circumstance); and
Medical devices that are not novel/ not based on new technology and have an established history of use for at least > 5 years; and
Medical devices that are supplied at low prices, which companies view as not justifying the high registration cost to HSA
Criteria B: Legacy MDs with no registered alternatives
Medical devices have at least three years of local clinical use in Singapore through SAR (with at least 2 consecutive GN-26 or GN-27 applications); and
Medical devices that have an established history of use for at least > 10 years; and
Legacy device necessity with no registered alternatives available in Singapore
Application Process:
Company are required to submit their request to participate in the registration support initiative by filling by form below, together with the relevant supporting documents. The submission window is open from 1 June to 31 August each year. HSA will review all submissions and notify companies of their fee waiver eligibility by 31 October. Companies that are eligible will be required to submit their product registration application within one year of receiving notification in order to qualify for the fee waiver.
Submit SAR Registration Support Initiative Request