Budget model: turning one-off and annual costs into an auditable table

This article is the 40th instalment of Volume 4, License-holder Import and Fees, of the Swiss Medical Device Registration 50-Article Series. Together with the remaining nine articles of this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below, so that readers can cite this article unambiguously and locate its companion pieces.

1. Key takeaways

The Swiss device compliance budget should be built along two lines, not as one mixed list: one-off costs (the CHRN issuance fixed fee of CHF 200, technical documentation preparation, product information in German, French and Italian, and notified body involvement where needed); and annual costs (the registration fees of Annex 2 — CHF 200 for the first UDI-DI, CHF 20 for each additional device in the same calendar year, capped at CHF 10,000 per manufacturer/SPPP per year, plus the hourly fee of Art. 4(2) at CHF 270 per working hour). The key to the three-year model is that one-off costs concentrate in year 1, annual costs level off in years 2 and 3 and become predictable, and the only genuine variable is the hourly fee. A table built this way can be presented to finance without caveats, because every fixed figure is closed-form and every estimate carries a stated method.

2. Legal basis

3. Expert insights

1. Registration fees are closed-form calculable; hourly fees are not. For N UDI-DIs, the annual registration fee is CHF 200 + CHF 20 × (N−1); at N = 491 the CHF 10,000 cap is reached, and from the 492nd device no further fees are charged. This formula makes the annual fixed spend fully predictable. The hourly fee, by contrast, depends on the hours Swissmedic invests and the number of round trips, and can only be estimated as expected hours × CHF 270. Mixing the two on a single budget line produces systematic distortion — year 1 is typically underestimated because one-off spending piles on top, while year 3 is typically overestimated because the linear growth up to the cap gets extrapolated beyond it.

1. The most underestimated one-off cost is not the official fee but language and documentation. The CHRN fixed fee is only CHF 200, and even both roles together amount to a few hundred francs; the truly large items are the product information in German, French and Italian and the Swiss adaptation of the technical documentation (Art. 16(2), Art. 6(1)–(2)). The opposing view — launch with an English version first and add the languages later — does not hold: the reduced-language conditions of Art. 16(3) are limited to constellations where four conditions are met concurrently, such as supply restricted to professionals and users possessing the necessary qualifications who agree, so treating an English version as the default is not a viable plan.

1. The three-year model must reserve time costs for two non-fee variables. First, the 3-month registration window of Art. 55(1) from first placement and the 1-week change reporting of Art. 55(2) are continuous manual efforts rather than one-off actions. Second, from 1 January 2027 regular invoices are issued for new registrations during the year, which shifts the invoicing rhythm in years 2 and 3 from an annual snapshot to registration-driven billing, with a cash-flow profile different from year 1. Ignore these two points and the budget table fails at the finance gate, however accurate its official-fee figures may be.

4. Practical recommendations

1. Structure the table in three columns — one-off / annual fixed / annual variable — and forbid mixing the categories; compute the annual fixed line with the registration fee formula and estimate the annual variable line by hours.
2. Build the year 1 budget as one-off investment plus the first billing year up to the 31 December 2026 snapshot, and mark the first billing date separately in the table.
3. For multi-entity groups, calculate the registration fees per manufacturer legal entity, each applying its own CHF 10,000 cap, with no cross-entity pooling.
4. Estimate hourly fees at CHF 270 per working hour with a buffer (practical estimate: an uplift of 20%–30%), never at the old rate of CHF 200.
5. Convert the manual actions — 3-month registration, 1-week change reporting, status inventories and notifications — into hours and include them in the annual operating cost, so the budget table shows more than the official fees alone.

5. Verification checklist

• □ The budget table is split into one-off, annual fixed and annual variable columns
• □ The annual registration fee is computed with CHF 200 + CHF 20 × (N−1), annotated with the CHF 10,000 cap and the 491-device threshold
• □ Hourly fees are estimated at CHF 270 per working hour with a buffer
• □ CHRN-related fixed fees are included in the one-off costs by number of roles (CHF 200 each)
• □ Three-language product information and Swiss adaptation of the technical documentation are listed separately, not mixed with official fees
• □ The three-year cash flow distinguishes the first billing (31 December 2026 snapshot) from regular invoicing from 1 January 2027

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For budgeting GRZAN provides Swiss authorized representative (CH-REP) services, builds the two-line budget model separating one-off costs from annual fixed and annual variable costs, computes registration fees with the CHF 200 + CHF 20 × (N−1) formula and the CHF 10,000 cap, and estimates hourly charges at CHF 270 with buffers, so that the cost of Swiss market entry is predictable, auditable and ready for finance review. For CH-REP appointment, budget model design or fee planning support for the Swiss market, contact info@grzanglobal.com.