In brief
On 28 August 2026, the Health Sciences Authority (HSA) announced a Registration Support Initiative to facilitate the transition of clinically important unregistered medical devices from the Special Access Route (SAR) to a sustainable formal registration pathway. This follows from our previous update regarding this Registration Support Initiative.
HSA will waive evaluation fees for eligible devices to reduce the regulatory costs associated with registration. The inaugural application window is open until 31 December 2026, and the initiative will thereafter be open annually from 1 October to 31 December.
In more detail
The SAR enables patient access to unregistered devices in exceptional circumstances, but is not intended as a long-term supply mechanism. The initiative addresses two key barriers to registration:
- Devices supplied at low volumes and low prices, where registration costs are seen as disproportionate
- Legacy devices with a long history of clinical use, where the costs and administrative burden of preparing registration dossiers have deterred registration
Unregistered medical devices that meet all the qualification criteria under either Criteria A or Criteria B will be eligible for the SAR Registration Support Initiative:
- Criteria A – Essential life-saving devices for rare clinical situations: Class C or Class D devices; essential or life-saving and used in rare clinical situations; not novel and not based on new technology, with an established history of use of at least five years; and 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 devices with no registered alternatives: at least three years of local clinical use in Singapore through the SAR by at least 2 consecutive GN-26 or GN-27 applications; an established history of use of more than 10 years; and no registered alternatives available in Singapore.
HSA has further elaborated on the application process and documentary requirements.
Key takeaways
Medical device companies that currently supply unregistered devices in Singapore through the SAR should consider whether any such devices may qualify for the Registration Support Initiative. The initiative is particularly relevant to devices serving small patient populations with limited commercial viability in Singapore. Eligible devices will benefit from a waiver of HSA's evaluation fees, facilitating their transition from the SAR to a sustainable formal registration pathway. Clinicians may also identify potentially qualifying devices and engage the relevant device suppliers to initiate the process.
© 2026 Baker & McKenzie. Wong & Leow. All rights reserved. Baker & McKenzie. Wong & Leow is incorporated with limited liability and is a member firm of Baker & McKenzie International, a global law firm with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a "principal" means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an "office" means an office of any such law firm. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome.