
Switzerland Steps to Market
15 January 2022
Has EUDAMED been delayed until 2023?
24 January 2022Page Last Updated: 13 January 2026
- What is a Swiss Single Registration Number (CHRN)?
- Why is a CHRN Needed?
- Is a CHRN Mandatory or Voluntary?
- Who Needs a CHRN?
- How Do Non-Swiss Manufacturers Register in swissdamed?
- Process to Obtain a CHRN
- Deadline to Obtain a CHRN
- Timing to be Issued a CHRN
- CHRH Fees
- Validity Period
- Recap: Differences Between a Swiss CHRN & EU SRN
What is a Swiss Single Registration Number (CHRN)?
The CHRN is Switzerland’s version of the EUDAMED Single Registration Number (SRN).
Why is a CHRN Needed?
A CHRN is required in place of the EUDAMED Single Registration Number (SRN) because the Mutual Recognition Agreement (MRA) between Europe and Switzerland lapsed for medical devices and IVDs. After 26 May 2021 (medical devices) and 26 May 2022 (IVDs), the free movement of devices between the two areas was no longer allowed. Further, the EU Commission removed Switzerland’s Competent Authority level access to EUDAMED.
Since Switzerland’s regulations reference EUDAMED throughout, it had to quickly address the gap. This included creating its own version of European SRNs – Swiss Single Registration Numbers.
As a result, Swissmedic is developing its own EUDAMED-like registration database, called ‘swissdamed’. It consists of two registration modules:
- Economic Operators
- Medical Devices
The Economic Operator module has been live since 6 August 2024.
The Medical Devices module will become mandatory on 1 July 2026, followed by a 6-month transition period. Meanwhile, sections of the device module were published for voluntary registration since 18 August 2025.
For more information, please read: Swiss Registration Database (Swissdamed)
Is a CHRN Mandatory or Voluntary?
A CHRN is mandatory for Swiss-based Manufacturers, Authorized Representatives and Importers.
Who Needs a CHRN?
The following need a CHRN:
- These four types of organizations require a CHRN: Manufacturers, System/Procedure Pack Producers, Authorized Representatives, and Importers.
- Further, only companies located in Switzerland require a CHRN. For example, a manufacturer located in Germany or Canada, does not need, and cannot get, a CHRN. This is different from Europe, which requires an SRN for all manufacturers, irrespective of where they are located. Instead, the foreign manufacturer’s Swiss Authorized Representative (AR) and Importer must obtain a CHRN.
NOTE: Even though a distributor is also an economic operator, they do not require a CHRN. This is the same as Europe’s Economic Operator registration requirements.
How Do Non-Swiss Manufacturers Register in swissdamed?
Non-Swiss manufacturers marketing in Switzerland must be identified in the ‘swissdamed’ database.
However, as noted above, only Swiss economic operators can register as an Actor. Therefore, it falls to the Swiss Authorized Representative (CH-REP) to register the non-Swiss manufacturer in swissdamed.
Once registered, the manufacturer will be issued a “Mandate ID”, instead of a CHRN.
Further, your company details will then be publicly available: 1) go to swissdamed ‘Search for Actors’, 2) enter your company in the ‘Company Name’ field, and 3) click on the search result.
Process to Obtain a CHRN
Swiss Manufacturers, Authorized Representatives, and Importers must submit an application via the swissdamed portal. But first, a user-specific CH-LOGIN (federal administration account) must be obtained. This is similar in concept to the ‘EU login account’ required for EUDAMED.
Swissmedic has published a User Guide, which details the exact steps to obtain a CH-LOGIN and complete the CHRN registration process.
The swissdamed public database is available: HERE
Deadline to Obtain a CHRN
Swiss Manufacturers, Authorized Representatives and Importers must obtain a CHRN within three months of placing their first product on the Swiss market.
Timing to be Issued a CHRN
Swissmedic’s official timeframe to process CHRN requests is 30 days. However, they also state that “if the volume of applications is low, the processing time may be shorter”.
CHRH Fees
Swissmedic charges “a flat fee of CHF 200” to process CHRN requests.
This amount will be invoiced after the CRHN application has been processed. Invoices will only be issued to an address in Switzerland. Companies can wait to receive the invoice by post, or can submit a request to receive invoices by e-mail.
Validity Period
CHRNs do not expire. However, Swissmedic must be notified of changes within one week.
The types of changes that must be notified include:
- Details of the economic operator
- Change to the Swiss Economic Operator’s Person Responsible for Regulatory Compliance (PRRC)
- Contact details for the organization
- Update to invoice address
Further, the CHRN data must be reviewed for correctness after 12-months, and then every two years thereafter.
Recap: Differences Between a Swiss CHRN & EU SRN
| EUDAMED SRN | Swiss CHRN |
|---|---|
| Voluntary until 28 May 2026 | Mandatory within three months of placing a new device onto the Swiss market |
| SRN is issued by one of the many national Competent Authorities | CHRN is issued by Swissmedic |
| SRN issuance timeframe varies, depending on which national competent authority is selected | CHRN issued within 30 days |
| Registration request is made through the EUDAMED portal | Registration request is made through the swissdamed portal |
| No fee to register in EUDAMED | Flat fee of CHF 200 per CHRN |
| All manufacturers need an SRN, irrespective of where they are located | Only Swiss manufacturers need a CHRN |
| Manufacturers identify their EU Authorized Representative (AR), and upload the AR Mandate, when they submit their SRN request to the Competent Authority | n/a – Foreign manufacturers have no interaction with Swissmedic during this process |
| EU AR must obtain an SRN | Swiss AR must obtain an CHRN |
| EU AR must review & verify the Mandate that was uploaded by the manufacturer, before an SRN can be issued by the national Competent Authority | Swiss AR must directly register the non-Swiss manufacturer in swissdamed |
| Importers need an SRN | Importers need a CHRN |
| Distributors do not need an SRN | Distributors do not need a CHRN |
| SRN data must be confirmed as still valid after one year, then every two years thereafter | CHRN data must be confirmed as still valid after one year, then every two years thereafter |
| SRN information must be updated as changed | CHRN information must be updated as changed |


