SINGAPORE · MEDICAL DEVICES

Singapore HSA Registration Fees and Timelines: Budgeting by Route

Budgeting a Singapore medical device registration means settling three things together: the risk class, the evaluation route and the number of applications. Two Class C devices can carry quite different HSA fees and official target timelines depending on whether they go through the Abridged or the Full route, and if models planned for one application have to be split, the budget changes too.

This article deals only with how fees and timelines are calculated. Amounts follow HSA’s current fee page and are in Singapore dollars (S$); timelines are official target turnaround times (TAT) in working days. For the overall market-entry process, classification and local registrant arrangements, see MediPass Singapore medical device registration.(Source: HSA fees and turnaround time page, updated 26 March 2026)

In what order should the budget be built?

We suggest working through these steps, with evidence behind each conclusion, rather than starting from the cheapest row in the fee table:

• Step 1, confirm the risk class: classify against the labelled use intended for Singapore; the class decides which rows of the fee table apply.
• Step 2, check route eligibility model by model: reference approvals, years on the market, safety record and exclusion lists decide whether Abridged, Expedited or Immediate is open to you.
• Step 3, settle the number of applications: complete the grouping assessment first, then decide how many applications to file.
• Step 4, decide on Priority Review: relevant only for the Full route; weigh the extra evaluation fee against the working days saved.
• Step 5, convert to a calendar plan: list pre-submission preparation, official working days, stop-clock for queries and post-approval launch preparation separately.

How does route eligibility decide which fee row applies?

HSA sets different routes according to overseas reference agency approvals, marketing history and safety record, and the cheaper routes are open only if the criteria are met. Based on HSA’s route overview and GN-15:

• Abridged: approval from at least one of HSA’s overseas reference regulatory agencies. GN-15 also provides for reliance on Malaysia’s MDA: Class B, C and D devices that have undergone full conformity assessment by an MDA-recognised CAB and are registered with MDA can use the Abridged route (devices incorporating registrable medicinal products, and borderline products classified differently by MDA and HSA, are excluded).
• Expedited (Class C ECR-1/ECR-2, Class D EDR): ECR-1 needs approval from at least one independent reference agency, at least three years on the market in that jurisdiction and no safety issues globally in the last three years (no reported deaths or serious deterioration in health, and no open field safety corrective actions, including recalls, at submission); ECR-2 and EDR need approval from at least two independent reference agencies; all require that the device has not been rejected or withdrawn by HSA or a reference agency due to quality, performance/efficacy or safety issues, including refusal to register specific models in an application. Hip, knee and shoulder non-bioactive joint replacement implants cannot use ECR; active implantable devices and implantable devices in contact with the central circulatory or nervous system cannot use EDR.
• Immediate: Class B IBR is available to qualifying Class B devices in general; the Class C Immediate route is solely for qualifying standalone medical mobile applications, so it cannot be used to promise immediate registration for ordinary hardware or IVD reagents.
• Common conditions: reference approvals must cover the same labelled use intended for Singapore. The Expedited and Immediate routes require approvals from independent reference agencies: EU and TGA approvals count as independent only where the agency actually reviewed and approved the device, not where it was registered under a Mutual Recognition Agreement (MRA).

Every device in an application, whether grouped as SINGLE, FAMILY, SYSTEM or GROUP, must meet the criteria of the selected route; it is not enough for one model to qualify. An application that does not qualify is re-routed to the correct route and that route’s evaluation fee applies; an IBR application that fails any eligibility criterion has its registration cancelled and fees are not refunded. A wrong eligibility call therefore changes the budget, not just the timeline.(Source: HSA registration overview; Class C expedited registration guide; GN-15 R15, Sections 4.3, 4.3.1, 4.4, 5.1, 5.3, 5.4 and 6.1)

How do the application fee and evaluation fee add up?

The application fee for any Class B, C or D product registration is S$560. The table below adds it to each route’s evaluation fee on HSA’s fee page to give the base HSA fee for one application. The subtotal excludes annual retention fees, other HSA transactions, testing and service fees.(Source: HSA fees and turnaround time page)

The fee page gives the Immediate routes’ timeline as “Immediate upon submission”. GN-15 Section 4.3.1 adds that devices on an Immediate route are listed on the SMDR upon successful submission and receipt of full payment; for a Class B IBR application, online payment is processed immediately, while GIRO payment takes 3 to 5 working days.(Source: GN-15 R15, Section 4.3.1)

Class D devices with a registrable drug have their own fee rows: evaluation fees of S$10,600 (Abridged) and S$75,600 (Full), with targets of 220 and 310 working days; with the S$560 application fee, that is S$11,160 and S$76,160. Confirm the drug–device classification for these projects separately rather than applying the standard Class D figures above.(Source: HSA fees and turnaround time page)

Priority Review: how much more, and how much faster?

The Priority Review Scheme applies to Class B, C and D devices submitted via the Full route, excluding Class D devices with a registrable drug in a secondary role. Route 1 requires both criteria to be met: the device falls within an HSA focus area (the current page lists cancer, diabetes, ophthalmic diseases, cardiovascular diseases, infectious diseases and skin diseases), and it is designed and validated for an unmet clinical need. Full-route applications that do not meet both criteria can use Route 2. HSA reviews whether the device fulfils all criteria for the selected route and may issue an input request.(Source: HSA Priority Review Scheme, updated 4 May 2026)

Both routes share the same target; they differ only in fee and eligibility. For Class C, a standard Full application costs S$6,810 in base HSA fees with a 220-working-day target; under Route 1 it is S$7,560 and 143 working days. The shorter target assumes a complete dossier and prompt responses to queries; it is not a guaranteed approval date.(Source: HSA fees and turnaround time page)

When does the official clock start, and when does it stop?

GN-15 Section 9 states that the target TAT runs from the date HSA receives the application and does not include stop-clock time due to input requests for clarification; the targets themselves are published on HSA’s website. The stop-clock begins when HSA issues an input request and ends only on receipt of a complete and satisfactory response that addresses the queries or gaps identified, so an incomplete response does not restart the clock. If the device is the subject of a field safety corrective action (FSCA), the application is placed on stop-clock until the FSCA is resolved or any action HSA deems necessary is completed. HSA’s fee page likewise notes that TAT excludes the time the applicant takes to respond.(Source: GN-15 R15, Sections 4.3, 5.3 and 9; HSA fee page)

Illustrative timeline (hypothetical, not based on any specific product): a Class C Abridged application receives two rounds of queries, and the manufacturer takes 20 calendar days to answer each. Those 40 calendar days sit outside the 160-working-day target; the working days must also be converted to calendar time allowing for weekends and Singapore public holidays, before adding pre-submission and post-approval launch preparation. “160 days” therefore cannot be used to back-calculate a fixed launch date, and contracts and commercial plans are better expressed in stages, assumptions and dependencies.

How do multiple models change the budget?

Where the grouping criteria are met, several devices can be registered in one application (for example as a Family, System, Group or IVD Test Kit), which can save fees and processing time; whether they can be combined must first be assessed against HSA’s grouping rules. HSA has discontinued the “IVD Cluster” grouping in GN-12-1 with effect from 2 June 2026, so IVD projects planned on that basis should recheck how many applications they need; see COVID-19 IVDs move to Class C and IVD Cluster discontinued.(Source: HSA grouping page, updated 5 October 2026)

Illustrative budget (hypothetical): if a set of models can go in as one Class C Abridged application, the base HSA fee is S$560 + S$3,900 = S$4,460; if it has to be split into two applications on the same route, that becomes S$8,920. If one added model is not covered by the reference approval, it affects whether the whole application can use the Abridged route, so check whether it can be filed separately or on another route before quoting. Before quoting, we suggest a configuration table setting out the models to be sold, intended use, scope of the reference approval and grouping basis side by side, rather than presenting unconfirmed models as a single “one-licence package price”.

Which costs should be listed separately?

Applicants can opt in at submission to a progressive payment scheme for evaluation fees, available only when paying by GIRO and only for the Full, Abridged and Expedited routes. HSA fees can be paid by GIRO or eNETS. HSA pre-market consultations are charged separately; see HSA pre-market consultation (PMC). Local registrant services, dealer’s licences, testing, translation and external technical work are separate cost items; a project budget should show who charges each item, the charging unit and the stage at which it arises, rather than folding everything into an unverifiable “government fee”.(Source: GN-15 R15, Section 10; HSA fee page)