In February 2024, the Swiss Agency for Therapeutic Products (Swissmedic) announced that the actor registration module of Swissdamed will be available in the second half of 2024. Swissdamed is a database for the registration of Swiss manufacturers, importers, and authorised representatives with the Swiss competent authority.
Swissdamed implementation timeline
In June 2023, Swissmedic trialled the Act Module of Swissdamed for registering economic operators. This pilot phase – in which 17 volunteer companies participated – enabled the refinement of the platform and the successful finalisation of the first ACT Module.
Swissmedic plans to roll out Swissdamed in three releases, starting with economic operator registration, followed by medical device registration, and concluding with additional functions. Registration will be mandatory once relevant amendments are made to the ordinances, but voluntary registration is currently available.
There has been, however, a delay in the official inauguration of Swissdamed. The initial roll-out plan foresaw a fully functional platform by the end of 2024. Nevertheless, the completion of this new IT infrastructure, along with the transferral of the associated data, has resulted in a deferral to the second half of 2024 of the Economic Operators’ registration, and to the first half of 2025 of the Device registration. Until then, Swiss economic operators will be able to register with Swissmedic.
Swissdamed platform design
Swissdamed emerges as a pivotal platform akin to the EU’s Eudamed. Similar to Eudamed, Swissdamed aims to enhance transparency by making information accessible to the public and healthcare professionals. And similar to Eudamed, Swissdamed will be articulated into modules:
- Actor Registration Module: This module will allow Swiss manufacturers, authorised representatives, importers, and other economic operators to register and manage their information.
- Device Registration Module: Manufacturers will use this module to register their medical devices before placing them on the market. It will include the registration of the UDIs associated with the devices.
Presently, economic operators are registered through the CHRN application form. However, once Swissdamed becomes fully operational, the registration will occur directly through the platform. Those already possessing a Swiss Single Registration Number will have their data imported into the system and will not need to re-register upon the Swissdamed launch.
Who is affected by the Actor registration requirement?
Unlike their Swiss counterparts, who are required to register on Eudamed, non-Swiss manufacturers will not currently need to register on Swissdamed.
This requirement involves, in fact, only Swiss economic operators: manufacturers, authorised representatives, and importers must provide Swissmedic with the required information within three months of introducing a product to the market. Distributors do not require a CHRN.
What steps should non-Swiss manufacturers follow to access the Swiss market?
The initial step for non-Swiss manufacturers aiming to enter the Swiss market involves appointing a Swiss Authorised Representative, also known as a CH-REP. According to Article 4 of the MedDO and IvDO, an “authorised representative” is defined as any individual or legal entity established within Switzerland who has been given and accepted a written mandate from a manufacturer located in another country to act on behalf of the manufacturer in relation to specific tasks concerning the latter’s obligations under the Ordinance.
Therefore, it is essential to have a mandate between a manufacturer based outside Switzerland and a Swiss authorised representative.
This information should be provided along with the completed Notification mandate form, including the following details:
- Manufacturer’s information
- Swiss authorised representative’s information
Chiara Lai
Regulatory Affairs Department
21/02/2024
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References:
Swissmedic (2024) Swissdamedi Overview. Retrieved on 21/02/2024.
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