Hourly rate rises to CHF 270: the cost structure after 1 July 2026

This article is the 36th 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 hourly rate rises from CHF 200 to CHF 270 per working hour with effect from 1 July 2026 (FeeO-Swissmedic, SR 812.214.5, Art. 4(2)), the first increase of this rate since 2002, an increase of 35%. Ongoing procedures are billed according to the day on which the service is provided — in other words, open items that cross 1 July 2026 will be priced in segments. The increase does not change the fixed registration fees of Annex 2; what it changes is every administrative service billed by the hour, which is precisely the part of the compliance budget that is hardest to predict. Companies that carry forward historical cost figures without noticing the new rate will systematically understate their Swiss regulatory spending from mid-2026 onward.

The practical reading of this article is a planning instruction rather than a warning. The rate change is published, dated and certain, so the correct response is mechanical: every budget line, service agreement and cost model that touches Swissmedic procedures must be re-based to the new rate before the effective date, and every open procedure must be tracked so that its segmented billing can be verified line by line.

2. Legal basis

3. Expert insights

1. The two cost blocks of Swiss device regulation must be viewed separately. One block is the registration fees of Annex 2: fixed rules, precisely calculable — CHF 200 for the first UDI-DI, CHF 20 per increment, annual cap of CHF 10,000. The other block is the hourly fee of Art. 4(2): the rate is fixed (CHF 270 per hour) but the hours are not predictable. The 35% increase amplifies only the second block, and what it amplifies is the number of round trips between the company and Swissmedic — the very part least under the company’s control. The conclusion for budgeting is that controllable and uncontrollable spending must be listed separately and never estimated with the same logic.

1. Billing by the day of service provision closes the door on locking in the old price. A conceivable plan would be to concentrate submissions before 30 June 2026 in order to lock in the old CHF 200 rate; but the rule anchors on the date the service is performed, not the date the application is submitted, and any portion of the service extending past 1 July 2026 is billed at CHF 270. Seen the other way round, the same rule has a favorable side: services completed before 1 July 2026 are not retroactively recalculated at the new price, so work finished under the old rate stays under the old rate.

1. The only effective cost lever is reducing round trips. A rejected CHRN application is billed according to the hours actually worked rather than another payment of the CHF 200 fixed fee, which shows that the legislature intends application quality to determine spend directly. Getting the file right in one pass is more practical than seeking relief afterwards. This is the same logic as the remediation window described in article 33: completing the remediation within 30 days avoids rejection, while dragging the remediation out converts directly into hours billed.

4. Practical recommendations

1. All budgets covering dates after 1 July 2026 must be built at CHF 270 per working hour; never extrapolate from historical data computed at CHF 200.
2. Estimate uncontrollable spending as expected hours multiplied by CHF 270, with a buffer on top (practical estimate: an uplift of 20%–30% on the calculated figure).
3. Where an open procedure crosses 1 July 2026, require the service provider to record the hours by service date in segments, so that the invoice can be checked line by line.
4. Run a full completeness and consistency self-check before every submission to reduce remediations and rejections — this is the only action that reliably pushes the hourly component down.
5. In the service agreement with the CH-REP, state clearly who bears hourly-type fees and how the detail of hours is verified, so that invoices never arrive without a traceable breakdown of working time.

5. Verification checklist

• □ The budget now uses CHF 270 per working hour, with the old value of CHF 200 applied only to services up to and including 30 June 2026
• □ The fixed registration fees of Annex 2 and the hourly fees of Art. 4(2) are tracked as two separate cost lines
• □ Open procedures crossing 1 July 2026 have segmented hour records in place
• □ The pre-submission self-check list is executed and remediation counts feed internal performance reviews
• □ Uncontrollable spending carries a buffer above the estimated hours (practical estimate)
• □ The CH-REP agreement states who bears hourly fees and how the hour detail is checked

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For cost matters GRZAN provides Swiss authorized representative (CH-REP) services, monitors the hourly billing of Swissmedic procedures at the new CHF 270 rate, keeps segmented hour records for open procedures, and builds fee budget models that separate the fixed registration fees of Annex 2 from hourly-based charges, keeping the cost of Swiss market entry predictable even under the new rate. For CH-REP appointment, cost monitoring or fee budgeting support for the Swiss market, contact info@grzanglobal.com.