As a provider of the "CH-REP“ verfolgen gespannt die Entwicklung der Schweizerischen Datenbank „swissdamed“, die für mehr Transparenz in unserem Markt sorgen soll. Das Schweizerische Heilmittelinstitut swissmedic recently announced that the "go-live" planned for the first quarter will have to be postponed to the second half of the year.
The development of the first ACT module (Release 1.1) is functionally complete. The UDI module is currently being developed. Swissdamed is planned to go live directly on the Swissmedic Cloud. The development of this new IT infrastructure, combined with the necessary transfer of swissdamed, will lead to a delay in the go-live until the second half of 2024. Until then, the registration of stakeholders and changes to data will continue to be carried out via the established channels.
Swissdamed is an IT system set up by Swissmedic to implement the Swiss regulations for medical devices and in-vitro diagnostics. It consists of two interconnected modules that can only be accessed by registered users, as well as a freely accessible search function. The individual modules will be made available in stages.
- Registration of companies and economic operators
- swissdamed - freely accessible platform
- Registration of products - UDI module
BEO BERLIN offers the "CH-REP + IM" service in co-operation with its Swiss sister company. We want to ensure that the process runs smoothly and efficiently so that your products can continue to be sold successfully in Switzerland. Contact us!
(3 Rating(s), average: 5.00 out of 5)
Loading...
