Economic operators currently register using the CHRN application form (see below: BW630_11_001defi_FO_Form_Application_CHRN). The Actors module of swissdamed will be available from August 2024. Economic operators will then be registered exclusively via swissdamed.
Applications for registration and for changing the CHRN, as well as notifications for mandates, will continue to be accepted as PDF forms until 26 July 2024 (submission date). After that date, these forms will no longer be considered.
Economic operators who have already registered with Swissmedic and therefore already have a unique Swiss Single Registration Number (CHRN) will be informed of the next steps at the beginning of August when swissdamed is available via the contact person provided to us when registering.
Economic operators must register within three months of placing a device on the Swiss market. This timeframe is intended to avoid delays in bringing compliant devices onto the market and to prevent supply bottlenecks in Switzerland.
After registering, economic operators do not have to go through the process again to place new devices on the market subsequently.
CHRN (Swiss Single Registration Number)
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 CHRN is a unique Swiss registration number that Swissmedic assigns upon request, once only, to the economic operators concerned. The CHRN is used to identify them unambiguously. The CHRN consists of the abbreviation “CHRN” followed by the abbreviation of the role for which the actor is registered, and finally by an eight-digit number (e.g. CHRN-MF-2345678), as explained in the table below.
CHRN Mind Map
Who does this concern?
The CHRN is assigned to Swiss manufacturers, authorised representatives and importers (pursuant to Art. 55 MedDO and Art. 48 IvDO). Each Swiss economic operator concerned must register with Swissmedic and provide the required information.
Any persons bringing systems and procedure packs onto the market for the first time must provide Swissmedic with their name and contact address within three months of bringing the system or procedure pack onto the market (Art. 55 (5) MedDO).
When submitting an application for registration of an operator, economic operators must attach a document in evidence of their domicile in Switzerland (i.e. extract from the commercial register or certificate of residence).
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.
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.
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.
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.
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
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.
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.
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.
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.
Owing to the revision of the applicable legislation for medical devices and in vitro diagnostic medical devices on 18 October 2022, economic operators based in Liechtenstein must now also register with Swissmedic.
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:
Economic operators from Switzerland and Liechtenstein registered at Swissmedic
The overview shows all manufacturers, importers and authorised representatives domiciled in Switzerland or Liechtenstein registered at Swissmedic. The list is updated daily.