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Health Sciences Authority

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 26 August 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 formally register their unregistered devices.

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.

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.

Submission Window

This is a recurring annual exercise. The submission window is open until 31 December 2026. Going forward, submissions will be accepted from 1 October to 31 December each year.

Eligibility Criteria:

Unregistered medical devices that meet all the qualification criteria under Criteria A or Criteria B will be eligible for the SAR Registration Support Initiative.

Criteria A: Essential Life-Saving Medical Devices for Rare Clinical Situations

  • Medical devices that are higher risk (i.e. Class C or Class D); and

  • Medical devices that are essential or life-saving in nature and are used in rare clinical situations (i.e. limited use circumstances); and

  • Medical devices that are not novel, are not based on new technology and have an established history of use for at least 5 years; and

  • Medical devices supplied at low prices or in small quantities, where the company declares that the cost of registration is not justified by the commercial value of the device in the Singapore market.

Criteria B: Legacy MDs with no registered alternatives

  • Medical devices with at least three years of local clinical use in Singapore through the SAR by at least 2 consecutive GN-26 or GN-27 applications; and

  • Medical devices with an established history of use for more than 10 years; and

  • Medical devices that are legacy devices with no registered alternatives available in Singapore.

Application Process:

For Medical/Dental Practitioners (Steps 1 to 3)

Step 1 — Identify eligible devices. Review your unregistered devices currently accessed through the SAR and assess whether they meet Criteria A or B above.

Step 2 — Complete and obtain endorsement of the Clinical Justification and Endorsement Form. Submit the completed form for endorsement from the relevant body:

  • For public healthcare institutions: Chairman of Medical Board (CMB). CMB is currently accepting endorsement requests.

  • For private healthcare institutions and clinics: Academy of Medicine, Singapore (AMS). AMS will begin accepting endorsement requests from 1 October 2026 onwards. AMS's contact details will be made available on the HSA website on or after 1 October 2026.

Step 3 — Pass the endorsed form to your device supplier. Forward the completed and endorsed Clinical Justification and Endorsement Form to the company supplying the device, so that the company may proceed with submission to HSA.

For Medical Device Companies (Step 4)

Companies should receive the completed and endorsed Clinical Justification and Endorsement Form from the relevant medical or dental practitioner before proceeding with Step 4

Step 4 — Submit to HSA. Prepare the Supporting Evidence (Company) form and submit it to HSA together with the endorsed Clinical Justification and Endorsement Form and all required supporting documents during the submission window.

HSA will review all submissions and notify companies of their fee waiver eligibility by April of the following year. Companies found eligible will be required to submit their product registration application within one year of receiving notification to qualify for the fee waiver.

Submit SAR Registration Support Initiative Request (opens in new tab)

Documentary Requirements: