Questions and answers

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.

For applications as manufacturer, importer: CHRN application form and current commercial register extract in PDF format.

For applications as authorised representative: CHRN application form, current commercial register extract in PDF format and mandate form

The documents can be sent directly using the application form or to chrn@swissmedic.ch.

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.

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.