CHRN application end to end: the swissdamed Actors module and the 30-day processing cap

This article is the 33rd 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 CHRN is obtained by submitting an application in the Actors module of swissdamed. The Swissmedic processing cap is 30 days; where an objection is raised and the file must be remedied, the response must be submitted within 30 days, and an overdue case is rejected. Issuance carries a fixed fee of CHF 200, and a rejected application is billed according to the hours actually worked. The number takes the form CHRN-MF-23456789. Registration is not optional: Art. 55(1) requires the manufacturer or its authorized representative and the importer to register within 3 months of first placing on the market, and Art. 55(4) provides that Swissmedic assigns the number after verification. The application is therefore not an administrative formality to be squeezed in after market entry but a milestone that must be scheduled against the statutory clock.

2. Legal basis

3. Expert insights

1. The 30 days are a processing cap, not the company’s preparation time. Overlay the 3-month registration window of Art. 55(1) with the 30-day processing cap of Swissmedic and the window actually available to the company is not generous: if the application is only submitted in the third month after first placement, a request for remediation can easily push the outcome past the 3-month line. The more robust schedule is to submit the application before placement, so that the number is already in hand when the first device goes to market. The opposing view — that some companies prefer to sell first and register later in order to test market response — fails in Switzerland, because the price of that path is a certain violation for delay rather than a negotiable grace period.

1. The remediation window is likewise only 30 days, and an overdue case is rejected. After rejection, billing follows the hours actually worked (Art. 4(2)) rather than another round of the CHF 200 fixed fee. The policy meaning of this fee structure is plain: the fixed fee corresponds to the standardized service of verification and assignment, while hourly reimbursement corresponds to the additional administrative input caused by an application of poor quality. In other words, getting the file right the first time is the cheapest option available, and every defect that slips through the internal review converts directly into Swissmedic working time charged at the applicable hourly rate.

1. Entities in Liechtenstein must also register, and an SRN cannot replace a CHRN. Following the ordinance amendment of 18 October 2022, economic operators located in Liechtenstein must likewise register with Swissmedic. This point is frequently misread as meaning that an existing EU SRN already covers Switzerland. There is no interface between Switzerland and EUDAMED and no synchronization between the two systems; the SRN and the CHRN are two independent number systems, and the former cannot substitute for the latter.

4. Practical recommendations

1. Plan backwards from the day of first placement: submit the Actors module application before placement and reserve both the 30-day processing cap and a possible 30-day remediation window.
2. The entity information submitted must match the commercial register and the letter of authorization exactly in name and address, so that a mismatch never triggers a request for remediation.
3. Confirm the role before applying: manufacturer/representative, importer, and assembler of systems or procedure packs correspond to different registration contents (Art. 55(5) additionally requires registration of the name and contact address for systems or procedure packs).
4. Start the internal response on the day the remediation notice arrives, and turn the 30-day remediation deadline into a calendar item with reminders; an overdue case is rejected and then billed by the hour with the whole process restarted.
5. Once the number is issued (example CHRN-MF-23456789), enter it into the master data system, and report any change of name, address or contact person within 1 week (Art. 55(2)).

5. Verification checklist

• □ It has been confirmed that the entity falls among the registration subjects listed in Art. 55(1) (manufacturer/representative, importer)
• □ The swissdamed Actors module account has been activated and entity authentication completed
• □ Name, place of business and contact address in the application match the official registration documents
• □ The submission date has been recorded, with calendar reminders for the 30-day processing cap and the 30-day remediation window
• □ The CHRN has been issued, example format CHRN-MF-23456789
• □ A change-reporting process has been established and changes are submitted within 1 week (Art. 55(2))

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For CHRN matters GRZAN provides Swiss authorized representative (CH-REP) services, prepares and submits the Actors module application on your behalf, tracks the 30-day processing cap and remediation windows, and keeps the 1-week change-reporting duty current after issuance. GRZAN also builds fee budget models covering CHRN fixed fees of CHF 200, device registration fees and hourly-based charges, so that the cost of registration stays predictable from the first submission to the first invoice. For CH-REP appointment, CHRN application management or fee budgeting support for the Swiss market, contact info@grzanglobal.com.