Economic operators must register with Swissmedic within a period of three months of placing a device on the Swiss market (pursuant to Art. 55 MedDO and Art. 48 IvDO).
As of 6 August 2024, applications for registration and for changing the CHRN, as well as notifications for mandates, are submitted via swissdamed.
When submitting such an application, evidence of domicile in Switzerland must be attached (i.e. extract from the commercial register or certificate of residence).
What happens for operators who are already registered?
Economic operators who had already registered with Swissmedic, before swissdamed became available, have been informed about the next steps by the specified contact person.
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 assigns, upon request, a Swiss Single Registration Number (CHRN) to the economic operator concerned, thereby allowing the operator to be identified unambiguously.
The CHRN consists of the abbreviation "CHRN", followed by the abbreviation for the requested role and an Eight-digit number (e.g. CHRN-MF-23456789), as explained in the table below:
CHRN Mind Map
Who does this concern?
The CHRN is issued to Swiss manufacturers, authorised representatives and importers, as well as to manufacturers of systems and procedure packs.
The CHRN is used for registering the economic operators. It is not used for registering 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 MedDO / Art. 91 IvDO).
The CHRN is issued to Swiss manufacturers, authorised representatives and importers, as well as to manufacturers of systems and procedure packs (according to Art. 55 MedDO and Art. 48 IvDO). The foreign manufacturer is not required to register in Switzerland as well 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 and importer must register with Swissmedic pursuant to Art. 55, para. 1 MedDO / Art. 48 para. 1 IvDO. This is subject to a deadline of 3 months after they have first placed medical devices or in-vitro diagnostics on the market.
As a result of 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.
If your firm requires a CHRN for more than one role, separate applications have to be submitted for these. It is not possible to issue a single CHRN for several roles.
In principle, Swissmedic has a maximum period of 30 days to process these applications. However, all applications are processed promptly, so if the volume of applications is low, the processing time may be shorter.
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.
Incoming applications are checked for content and the required evidence to substantiate the facts is formally checked for correctness.
If documents or information are missing from an application, or if they are invalid or incorrect, the application will be contested. If the requested adjustments/documents are not submitted within 30 days of an objection, the application will be refused.
Under Art. 55, para. 2 MedDO / Art. 48 para. 2 IvDO, the economic operator in question must report any changes to the information to Swissmedic within one week.
The change(s) should be entered by the economic operator directly in swissdamed. You can find corresponding instructions via the following link: Support swissdamed (swissmedic.ch)
