SINGAPORE · MEDICAL DEVICES

Singapore SAR Registration Support Initiative: which devices qualify for the evaluation fee waiver?

Unregistered medical devices that have long been supplied in Singapore through the Special Access Route (SAR) may qualify for HSA’s Registration Support Initiative, which waives the evaluation fees for their subsequent product registration. The first round of eligibility requests is open until 31 December 2026. A device must meet every condition under either Criteria A or Criteria B; low sales or high registration costs alone are not enough. (Sources: HSA initiative page; HSA announcement, 28 August 2026)

For overseas manufacturers, the first step is to confirm the product’s history with the Singapore supplier and the healthcare institutions that actually use the device. Whether you can obtain a clinical endorsement, SAR records that match the device, and a consistent product list usually decides whether a request has a sound basis.

Which two groups of devices does the initiative help?

HSA sets two groups of criteria, and every condition within a group must be met. The first two columns below follow HSA’s current page; the third lists the evidence we suggest gathering first. Actual submissions should follow HSA’s current forms. (Sources: HSA initiative page; HSA industry briefing, 20 May 2026, pp. 26–27)

Whether an alternative exists should be assessed against the actual clinical need, not concluded from a different brand, purchasing habits or price differences. The manufacturer can help clinicians describe the device’s features and use cases, but the clinical need itself should be stated by the relevant doctors and institutions.

Low volume also needs verifiable evidence. HSA’s briefing states that for Criteria A the company must explain, with reference to the expected supply quantity in the first year after registration approval, why a reasonable supplier would not consider the evaluation fees justified; it sets no specific price or volume threshold. Historical supply and projected demand can be compiled first, but these internal records cannot replace the healthcare institution’s clinical endorsement. (Source: HSA industry briefing, p. 30)

Which fee is waived?

HSA’s industry briefing of 20 May 2026 states that eligible devices receive a waiver of product evaluation fees and pay only the application fee; the announcement of 28 August likewise refers to waiving evaluation fees. Under HSA’s current fee schedule, the product registration application fee for Class B, C and D devices is S$560. Actual charges follow the fee schedule and invoice HSA publishes at the time of submission. (Sources: HSA industry briefing, p. 25; HSA fee schedule)

Evaluation fees vary with the risk class and evaluation route. For the full route, for example, the current schedule lists S$6,250 for Class C and S$12,000 for Class D; the actual amount waived depends on the route that finally applies. Promoting the initiative as “free registration” is therefore inaccurate, and it blurs the line between the eligibility request and the registration itself.

Companies still need to plan the technical documentation, product registration and post-market work. The briefing notes that once a device is listed on the SMDR, annual retention fees and post-market obligations apply; the current schedule sets retention fees at S$39, S$67 and S$134 for Class B, C and D. Testing, translation, local registrant and other third-party work is not made free by the fee waiver either, so budgets should show official fees and required services separately. (Sources: HSA industry briefing, p. 32; HSA fee schedule)

Who endorses clinically, and who submits to HSA?

The process starts with a medical or dental practitioner identifying a suitable device, completing the Clinical Justification and Endorsement Form and obtaining endorsement:

• Public healthcare institutions: endorsement by the Chairman of Medical Board (CMB), which HSA’s page shows is already accepting requests.
• Private institutions and clinics: endorsement by the Academy of Medicine, Singapore (AMS), which accepts requests from 1 October 2026.

The practitioner passes the endorsed form to the device supplier, which completes the Supporting Evidence (Company) form and submits it with the endorsed form and attachments through HSA’s designated online form during the submission window. HSA states that companies should proceed only once they have received the endorsed form. (Source: HSA initiative page)

Overseas manufacturers can prepare the technical and use-history information, while the local supplier links it to the actual SAR supply records. HSA’s briefing requires the company’s information to match the institution’s form, so both sides should work from a single product list in which labelled name, identifier, manufacturer, specifications and criteria group can be cross-checked. Avoid a clinical form that names a product family while the company form lists only some models, leaving HSA unable to confirm that both refer to the same device. (Source: HSA industry briefing, p. 28)

How should 2026 be scheduled?

HSA updated the initiative page on 1 October 2026: this round closes on 31 December 2026, and from then on requests are accepted from 1 October to 31 December each year. The schedule in the May briefing (requests from 1 June to 31 August 2026, notification by 31 October 2026, registration by 30 October 2027) has been superseded; follow the current page.

The one year is the deadline for submitting the registration to keep the waiver; it does not mean HSA guarantees approval within a year. The briefing also states that registration applications under this initiative have no committed turnaround time and that published turnaround times do not apply. Institutions, local companies and manufacturers should plan around their evidence gaps rather than work back from standard-route timelines to a fixed launch date. (Source: HSA industry briefing, p. 32)

Before requesting eligibility, reconcile your records

Preparation can be split into three linked records:

• Supply history: SAR application numbers, approval dates, institutions using the device, specific models and corresponding supply.
• Product history: year first marketed globally, technical principle, product versions and supporting records of use.
• Registration gaps: what is missing from the technical file, quality system, labelling and performance data.

“The product family has been used for ten years” and “the model being submitted has been used for ten years” may be different claims. If the technology, patient population or key models changed over that period, explain the change and decide which product the use history actually supports. Build an index first and have the responsible people retrieve the original evidence, rather than piling unrelated old documents into the request.

The manufacturer and local company should also agree upfront who obtains the endorsement from the doctor, who checks the SAR records, who answers eligibility queries and who handles the registration. Then, once HSA confirms eligibility, the technical file work can continue without a search for owners. These are MediPass’s project management suggestions; the documents actually required are set by HSA’s current forms and requirements.