Registration fees explained: CHF 200, CHF 20 and the CHF 10,000 annual cap

This article is the 35th 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

Device registration fees are levied under Annex 2 of the FeeO-Swissmedic: the first UDI-DI costs CHF 200; each additional UDI-DI within the same calendar year costs CHF 20; and the cap is CHF 10,000 per manufacturer/SPPP per year — under this structure, 491 devices reach the cap exactly, and from the 492nd device onward no further fees are charged. The first billing date is 31 December 2026, covering all UDI-DIs whose status on that day is On the market, while those marked No longer placed on the market on that day are not billed; from 1 January 2027 onward, regular invoices are issued for new registrations during the year. Data updates are free of charge, while re-registration after invalidation requires payment again; bills for foreign entities are sent to their CH-REP. The structure is fully calculable in advance, which makes it one of the few genuinely plannable cost blocks in the Swiss compliance budget.

2. Legal basis

3. Expert insights

1. The billing baseline is the status snapshot date, not the registration date. The first invoice is determined by the status on 31 December 2026, not by how many items were added on that day. This gives companies a clearly defined and legitimate space for action: marking products that have genuinely stopped being placed on the market as No longer placed on the market before 31 December 2026 means no fee is owed for those UDI-DIs. The opposing risk is just as real — marking too early strips products that still need to be placed of their valid registration, and re-registration costs money again. There is only one criterion: whether the product truly is no longer placed on the Swiss market.

1. The cap aggregates at the manufacturer/SPPP level, not at the CH-REP level. The trade-off in this rule is to make the fees follow the product-responsible party rather than the Swiss contact point. Two misjudgments are common: first, multi-brand groups assume a single CHF 10,000 cap can be pooled across legal entities, when in fact the aggregation is per manufacturer and each legal entity has its own cap with no pooling; second, CH-REPs assume they will be the ones billed, when in fact the bill is merely sent to the Swiss representative of the foreign entity and the payment responsibility rests with the manufacturer.

1. Free updates and paid rebuilds split maintenance from reconstruction. Changing fields generates no new fee, while re-registration after invalidation requires payment again — including a fresh start of the CHF 200 first-device fee and the CHF 20 increments (practical estimate: based on the number of items re-registered after invalidation). The conclusion is that during product-line consolidation, entity changes or coding overhauls, the data-update and status-management route should be preferred, with invalidation and rebuilding treated strictly as a last resort. This in turn requires the channel selection described in article 34 to support high-frequency updates without friction.

4. Practical recommendations

1. Before 31 December 2026, run a full status inventory of all UDI-DIs, mark items that have genuinely left the market as No longer placed on the market, and keep the inventory records as evidence in case of billing disputes.
2. Calculate annual registration fees separately per manufacturer legal entity, using the formula CHF 200 + CHF 20 × (N−1) capped at CHF 10,000, entity by entity, without any cross-entity pooling.
3. Foreign manufacturers should agree in advance with the CH-REP on a process for receiving, checking and settling bills, because bills are sent to the CH-REP while payment responsibility remains with the manufacturer.
4. Prefer data updates for product-line adjustments; where invalidation and rebuilding is genuinely unavoidable, budget for it separately and expect the items to be charged again as new registrations.
5. Mark 491 devices as the cap point in the annual budget: volumes beyond it generate no marginal registration fee, but registration and maintenance duties are not waived because the fee is zero.

5. Verification checklist

• □ UDI-DI ledgers and annual counts have been established separately per manufacturer/SPPP
• □ Fees have been calculated with the formula CHF 200 + CHF 20 × (N−1), annotated with the CHF 10,000 cap and the 491-device threshold
• □ The full status inventory before 31 December 2026 has been completed and archived
• □ The foreign entity and the CH-REP have agreed on a bill-receiving and checking process
• □ Approval paths for data updates versus invalidation-rebuilding are distinguished in the SOP
• □ The regular invoicing process for new registrations from 1 January 2027 onward is ready

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For fee matters GRZAN provides Swiss authorized representative (CH-REP) services, receives and verifies Swissmedic invoices on behalf of foreign manufacturers, runs the pre-billing status inventory ahead of 31 December 2026, and builds fee budget models using the CHF 200 + CHF 20 × (N−1) formula with the CHF 10,000 cap, keeping the cost of Swiss market entry fully predictable. For CH-REP appointment, invoice management or fee budgeting support for the Swiss market, contact info@grzanglobal.com.