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Swissmedic Updates eIAM Portal Administrator Guidance – Version 3.4 Effective February 2026
Commercial 4Easy PRRC 03/02/26 Commercial 4Easy PRRC 03/02/26

Swissmedic Updates eIAM Portal Administrator Guidance – Version 3.4 Effective February 2026

Swissmedic publishes eIAM Portal Administrator guidance version 3.4, effective February 2026. Learn what this means for manufacturers using Swiss eGov services.

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EU-U.S. Data Privacy Framework Updated: What It Means for Medical Device Manufacturers
Commercial 4Easy PRRC 30/01/26 Commercial 4Easy PRRC 30/01/26

EU-U.S. Data Privacy Framework Updated: What It Means for Medical Device Manufacturers

New EU-U.S. Data Privacy Framework FAQ impacts data transfers to U.S. vendors. What this means for medical device manufacturers in 2026.

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Australia Updates Guidance on Export Certificates for Medical Devices: What EU Manufacturers Need to Know
Commercial 4Easy PRRC 27/01/26 Commercial 4Easy PRRC 27/01/26

Australia Updates Guidance on Export Certificates for Medical Devices: What EU Manufacturers Need to Know

The TGA has updated its guidance on Certificates of Free Sale and Export Certificates for medical devices. Key changes for EU manufacturers exporting via Australia.

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ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026
Commercial 4Easy PRRC 12/01/26 Commercial 4Easy PRRC 12/01/26

ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026

ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

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TGA Updates Guidance on Varying ARTG Entries: Key Points for Medical Device and IVD Manufacturers
Commercial 4Easy PRRC 20/12/25 Commercial 4Easy PRRC 20/12/25

TGA Updates Guidance on Varying ARTG Entries: Key Points for Medical Device and IVD Manufacturers

The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.

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