Swiss Single Registration Number (CHRN)
Based on the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR. 812.219) Swissmedic, the Swiss Agency for Therapeutic Products, assigns the Swiss Single Registration Number (CHRN). The Swiss Single Registration Number (CHRN) is a Swiss unique registration number that Swissmedic assigns to Swiss manufacturers, authorised representatives and importers upon request. The CHRN is used to unambiguously identify a manufacturer, authorised representative or importer.
Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland. To mitigate the consequences of this loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorised representatives and importers domiciled in Switzerland to register once with Swissmedic.
Economic operators must register within three months of placing their first product on the Swiss market. This timeframe is intended to avoid delays in bringing compliant products onto the market and to prevent supply bottlenecks in Switzerland.
Once an economic operator has registered, it does not have to do so again when placing further products on the market.
The information sheet below describes the process for applying for a CHRN in detail.
Information Sheet and order form
The service agreement describes the services that the Swiss Therapeutic Products Agency provides in terms of issuing a Swiss Single Registration Number (CHRN) in accordance with MedDO Art. 55. It also describes the entitlements and obligations of the persons who make use of this service.
With each order, the service recipient explicitly agrees to the conditions of this service agreement.
Questions & answers
How long does it take to process a CHRN application?
What processing times apply for objections by Swissmedic?
In principle, Swissmedic has a period of up to 30 days for processing these applications. All applications are processed promptly, so if the volume of applications is low, the processing time may be shorter.
What are the fees for issuing a CHRN?
According to point 2.3.4 of the CHRN service agreement, the following applies: The Agency will process the application within a period of 30 days as of the date on which all the information and documents needed to provide the service are in its possession.
This means that in the case of objections, the submission date is no longer relevant for determining the processing time. The 30-day processing period only begins when all shortcomings have been rectified and Swissmedic has all the documentation required. The date of acknowledgement of receipt via e-mail can be used as the reference point.
What documentation has to be submitted?
How are changes to data reported?
Fees for issuing the CHRN and validating the documents required as evidence will be billed on the basis of the work involved in accordance with Art. 4 FeeO-Swissmedic. According to Art. 4 para. 2 FeeO-Swissmedic, the rate for work charged on an hourly basis is CHF 200 per hour. Experience has shown that issuing the CHRN requires one hour of work, which therefore generally corresponds to a fee of CHF 200.
Where can I find the French, English or Italian version of the registration form or the change of registration form?
Under Art. 55, para. 2 MedDO / Art. 48 para. 2 IvDO, the economic operator in question is responsible for reporting changes in data to Swissmedic within a period of one week. Changes must be reported using this form: Notification of information changes
Why isn’t it possible to submit scanned application forms?
There are no individual language versions for these two forms. The language can be changed by clicking on the appropriate language (abbreviation) in the top left corner of the form.
Does a separate application have to be submitted for each role?
All details from an application form are transferred into the Swissmedic business case processing system via XML import. Scanned forms lead to technical issues as the information is not recognised by the system and cannot be read.
Who needs a CHRN?
If your firm requires a CHRN for more than one role, separate applications have to be submitted for each role. It is not possible to issue a single CHRN number for several roles.
What is the purpose of the CHRN?
Pursuant to Art. 55, para. 1 MedDO / Art. 48 para. 1 IvDO, the registration requirement applies to Swiss manufacturers (based in Switzerland) or to the authorised representative (based in Switzerland) of the foreign manufacturer and to the importer (based in Switzerland). The foreign manufacturer/producer is not required to register in Switzerland but must appoint an authorised representative (within the deadlines stated in Art. 104a MedDO / Art. 86 IvDO for manufacturers in the EU/EEA).
The authorised representative (once appointed in accordance with transitional periods) and/or the importer must in turn register with Swissmedic pursuant to Art. 55, para. 1 MedDO / Art. 48 para. 1 IvDO. This is subject to a deadline of three months after they have first placed medical devices or in-vitro diagnostics on the market.
What are the registration deadlines for manufacturers, importers and authorised representatives?
The CHRN is used for registering the economic operators. It is not used for registering the products. The MedDO and IvDO articles on product registration (Art. 17 para. 5 MedDO / Art. 16 para. 5 IvDO) will come into force at a later date (Art. 110 MeDO / Art. 91 IvDO).
You can find further information on notifying devices here:
Do distributors need to register?
We kindly ask you to consult point 4.5 of the information sheet unique registration number CHRN.
No, there is no requirement for distributors to register.
Swiss economic operators registered at Swissmedic
The overview shows all manufacturers, importers and authorised representatives domiciled in Switzerland registered at Swissmedic. The list is updated daily.
Last modification 25.05.2022