Swissmedic Rolls Out New Swissdamed UDI Devices Module
Swissmedic has unveiled a significant enhancement to the Swiss database for medical devices, Swissdamed, with the launch of its UDI…
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UDI Registration in Swissdamed: Key Insights and Deadlines
With economic operator registration in the Actor module of Swissmedic’s Swissdamed database in force for Swiss…
Swissmedic Guidance Regarding System & Procedure Packs
Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and procedure…
New EU Regulation on eIFUs Adopted by Swissmedic
Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic instructions…
Swissmedic Requirements: Device Notifications for Manufacturers
Swissmedic, which is affiliated with the Swiss Federal Department of Home Affairs, is responsible for the regulatory oversight of…
EU MDR
EU IVDR
US Agent
General
UK Responsible Person
Egypt Registration Holder
Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
Swiss IvDO: Fast-Approaching Deadlines for IVD Manufacturers
As we’ve previously reported for non-IVD devices, under the new Swiss Medical Devices Ordinance…
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
Swissmedic: How Medical Device Regulation Has Changed
Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which we will explore below. But…
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