The CHRN – also known as Swiss Single Registration Number – is a unique identification number assigned to Swiss manufactures, authorised representatives, and importers upon request. It does not refer to the products, since art. 110 MedDo specifies that articles 17 paragraph 5 and 108 paragraph 2 on product registration will come into force at a later stage.
The CHRN system bridges the gap created by the not yet updated Mutual Recognition Agreement (MRA). Currently, economic operators domiciliated in Switzerland cannot obtain the European Single Registration Number (SRN) through the EUDAMED actor registration’s module. Therefore, the one-time-registration with Swissmedic – the Swiss Agency for Therapeutic Products – is necessary to ensure traceability of information as well as market surveillance in Switzerland.
Timeline: registration, verification, CHRN
According to Art. 55 of the Medical Devices Ordinance (MedDO), manufacturers, authorised representatives, and importers must register at Swissmedic within three months of placing their first product on the Swiss market. This rule also applies to natural or legal persons assembling systems and procedure packs in accordance with Art. 11 MedDO.
Upon completing the registration, Swissmedic verifies the information provided by the economic operators and assigns the CHRN within 30 days of receipt of the application and the necessary documentation.
Registration process with Swissmedic
The applicant must complete and submit the application form via e-mail to [email protected]. The form is available in German, French, Italian, and English. After asking for the details of the economic operator and the PRRC, the form includes a section dedicated to the payment of fees for the validation of the CHRN and the documents required as evidence. If additional administrative work is required (e.g., due to incomplete documentation), an extra administration fee of 200 CHF per hour is also charged.
The form requires the applicant to submit the following documents:
- Excerpt from the commercial register;
- Completed Mandate notification form for Swiss based authorised representatives.
Additionally, the requesting company needs to confirm that it is aware of and abides by the Service Agreement describing the services provided by Swissmedic in connection with the assignment of the CHRN. The Agreement specifies the rights and obligations of the applicants.
The updated list of all economic operators domiciliated in Switzerland and registered at Swissmedic can be found at this link: Swiss economic operators registered at Swissmedic | opendata.swiss
Giorgia de Stefano
VIP & Legal Department
11.03.2022
Interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorized Representative and turn your Swiss journey into a success story! Contact us today.
References:
- Swissmedic (2022). Information sheet Unique identification number – CHRN. Retrieved on 11/03/2022 from https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
- The Federal Council. (2022). Medical Devices Ordinance of 1 July 2020 (MedDO). Retrieved on 11/03/2022 from https://www.fedlex.admin.ch/eli/cc/2020/552/en