Swissmedic, die Zulassungs- und Kontrollbehörde für Heilmittel in der Schweiz mit Sitz in Bern, überprüfte Klasse I Hersteller auf Einhaltung der aktuellen Regulierungen. Im Fokus lagen hier die Überwachung der Produkte am Markt (z.B. Vorkommnisse mit den Produkten sowie Trends im Sinne eines Anstiegs der Anzahl der Reklamationen oder des Schweregrads der Vorkommnisse) durch die Hersteller (PMS).
70% of the audited documentation showed deficiencies, 39% of the audited companies showed irregularities in registrations and 11% were found to have such serious deficiencies that they had to be designated as not marketable.
Although the authority only examined Swiss companies in this action, it clearly indicates that the situation could be fundamentally the same for manufacturers whose registered place of business is not in Switzerland. It will also review this in due course. At this point, the CH-REPs play an important role, as they must ensure access to the manufacturers’ documentation.
The swissdamed medical devices database (“Swiss Database on Medical Devices”), which is currently being set up, will increase transparency with regard to products on the Swiss market and serve Swissmedic as a data basis for more comprehensive and broadly based controls. As far as we know, this database will then also make it possible to check whether there is a mandate for the designation of a CH-REP. At this point, we would like to briefly remind you that from 31.07.2023, also Class I products imported into Switzerland must also be marked with the CH-REP symbol and the corresponding address of the CH-REP on the product.
Contact us, if you export medical devices to Switzerland. Our CH-REP service offers you regulatory-compliant marketability in Switzerland.
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