swissdamed and direct imports
Must a Swiss hospital or medical practice register a CE-compliant medical device in swissdamed if it is sourced directly from the EU? Not automatically. The decisive factor is not the…
Category News
Technical article by VDE Health
Regulatory software creates the greatest value not by offering as many functions as possible, but by supporting a specific process reliably, transparently and with clear responsibilities. A recent article by…
EUDAMED to SWISSDAMED
Easily synchronise EUDAMED data with swissdamed: when manual XML export reaches its limits Export as XML, import into swissdamed – done. This is how many manufacturers and CH-REPs imagine transferring…
EUDAMED & HIBCC
EUDAMED & HIBCC: Does the Plus Sign Belong in the UDI-DI? An analysis of more than 3 million EUDAMED records reveals a surprising inconsistency in HIBCC UDI-DIs. Since 28 May…
Health Canada CESG
FDA ESG and Health Canada CESG: how medical device submissions have been transmitted electronically since April 2026 Existing FDA Gateway accounts can generally also be used for submissions to Health…
EUDAMED: Manufacturers take over SSCP and SSP upload
EUDAMED: Manufacturers to Upload SSCP and SSP Documents Themselves in Future With its position paper MDCG 2026-4, the Medical Device Coordination Group has announced a significant change to the management…
Swissmedic registration fees
swissdamed Deadlines and Registration Fees: Key Clarifications from Swissmedic Do manufacturers have to pay again every year for the same UDI-DI? Does it matter whether a product was registered before…
Webinar: Global UDI 2026 – EUDAMED, swissdamed & TGA Australia
Webinar: Global UDI 2026 -EUDAMED, swissdamed & TGA Australia Deadlines, Transition Periods and Practical Upload Solutions for Small and Large Companies UDI requirements are becoming mandatory in several important markets…
Transparency in the Global Submission Portal
Greater Transparency in the Global Submission Portal: Audit Trail, UDI Publication Report and EUDAMED–swissdamed Synchronization With the Global Submission Portal, Europe IT Consulting GmbH supports medical device manufacturers in centrally…
swissdamed registration fee
New Registration Requirement for Medical Devices: What Applies from July 2026 As of July 1, 2026, medical devices on the Swiss market must be registered in the national database swissdamed.…