Singapore Device Registration Fees: SGD 560 Application Plus Route Fees

1. Key takeaways

Registration fees for Class B, C and D devices in Singapore have two components: a flat application fee of SGD 560, plus a review fee determined by class and by the evaluation route chosen. Review fees range from SGD 1,000 for Class B Immediate to SGD 75,600 for Class D containing a registrable medicinal product on the Full route. Related fees sit alongside them: change notifications at SGD 560, SGD 1,890 or SGD 3,120, change of Registrant at SGD 880, and the dealer’s licence at SGD 1,110 per year. Budgeting on the review fee alone understates the cost of a Singapore submission, because the application fee applies to every route without exception.

• Two components, always. The SGD 560 application fee is charged on top of the review fee for every class and every route.
• Widest spread in the table. Review fees run from SGD 1,000 to SGD 75,600, a function of class, route and product definition.
• Priority routes cost more. Class D Full with Priority Route 1 is SGD 13,600 and Route 2 is SGD 17,500, against SGD 12,000 for standard Full.
• Annual costs are separate. Retention fees of SGD 39, SGD 67 or SGD 134 and the dealer’s licence at SGD 1,110 are recurring, not one-off.
• Official fees are only part of the budget. QMS certification, clinical evaluation, testing and dossier preparation usually exceed them.
• Figures move. The HSA fees page used here was updated on 26 March 2026 and must be rechecked before filing.

2. Legal basis

The figures below reproduce the HSA official fees and turnaround page, updated to 26 March 2026, and are grouped as HSA presents them: product registration, changes and holder transactions, and licences with related services. The fee schedule operates alongside GN-15 R15 for registration and GN-02 R8 for dealer licensing, and the route names used in the table are the route names used in the submission system. Because the schedule is administrative rather than statutory in its detail, it can be revised without a change to the Act, which is why the date of the page matters as much as the numbers on it.

A. Product registration

B. Changes and holder transactions

C. Licences and related services

3. Expert insights

The SGD 560 application fee is a fixed cost on every route and is never waived for choosing a cheaper one. The total official cost of a Class B Immediate submission is SGD 1,000 plus SGD 560, or SGD 1,560, and of a Class B Full submission SGD 3,900 plus SGD 560, or SGD 4,460. The application fee does not scale with the review fee and does not disappear when the review fee is low. Leaving it out of a budget is a small error that becomes visible only when the invoice arrives, by which point the project has already been priced to the client.

Class D with a registrable medicinal product at SGD 75,600 is the largest cost cliff in the table. It is 6.3 times the standard Class D Full fee of SGD 12,000. The distinction has to be identified at the product definition stage, because whether a device constitutes one containing a registrable medicinal product is a judgement that can change the economics of an entire project. Once the dossier has been built on the wrong assumption, re-positioning the product means rebuilding the submission and renegotiating the budget with the commercial team, so the question belongs in the earliest design review rather than in the filing checklist.

Priority Route 1 and Route 2 have the same duration but a significant price gap, so Route 1 should be pursued first. For Class D, Route 1 is SGD 13,600 and Route 2 is SGD 17,500, both at 202 working days, a difference of SGD 3,900. Whether the product can be argued to fall within HSA’s designated priority health areas, namely cancer, diabetes, cardiovascular disease, ophthalmic disease and infectious disease, and to address an unmet clinical need, determines which fee applies. That argument is a drafting exercise with a measurable financial return, and it is worth preparing properly rather than accepting the default.

The largest cost is usually not the official fee. Official fees are transparent and controllable, which is precisely why they attract disproportionate attention. The substantial items in a real project are QMS certification, including the fees of an SAC-recognised body, clinical evaluation, testing for biocompatibility, electrical safety, EMC, sterilisation and stability, dossier preparation, and consultancy. In client budgets we list official fees in one column and service and testing costs in another, because the second column is where projects overrun and where the contingency should sit.

Fees are dynamic and the official page governs. HSA revises its fee page from time to time, and the table above is compiled from the page as updated on 26 March 2026. Before any submission, the current values should be rechecked on the HSA website and the budget adjusted if they have moved. A quotation built on cached figures is a commercial risk that is easy to avoid, and the check takes only a few minutes at the point when the submission package is being finalised.

4. Practical recommendations

• Budget in two columns. Put official fees on one side and service and testing costs on the other, with contingency on the second.
• Add SGD 560 to every route. Apply the application fee to each option before comparing them.
• Screen for medicinal product content at project inception. A Class D combination product changes the fee by an order of magnitude.
• Argue for Priority Route 1 where the evidence supports it. On Class D the difference against Route 2 is SGD 3,900.
• Recheck the HSA fee page before filing. Treat every figure as valid only as at the date of the page.

5. Verification checklist

• □ The SGD 560 application fee is included in the budget
• □ The review fee is confirmed against class and route
• □ Annual retention fees of SGD 39, SGD 67 or SGD 134 are included
• □ The dealer’s licence at SGD 1,110 per year is included
• □ QMS certification, clinical evaluation and testing are budgeted separately
• □ The HSA website has been rechecked for current fees before submission

Regulatory information verified as of 26 October 2026; the HSA fees page was updated on 26 March 2026. Source tier: secondary (HSA official fees and turnaround page).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com