Swissmedic Announces Benocten Tropfen zum Einnehmen Lösung Batch Recall Notice
Swissmedic has issued a batch recall notice for Benocten Tropfen zum Einnehmen Lösung, a product used in healthcare settings. The…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Swissmedic Launches Registration for Legacy Devices
Swissmedic, the Swiss Agency for Therapeutic Products, has announced the availability of the “Legacy devices” registration system. As of February…
Europe
Swissmedic Issues Notification for Irbesartan Spirig HC Due to Text Error on Packaging
A recent notification issued by Swissmedic, the Swiss Agency for Therapeutic Products, has brought attention to a critical issue regarding…
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FDA Initiates Comprehensive Reassessment of BHA in Foods to Clarify Safety Standards and Regulatory Pathways
Publication date context February 11 2026 at 13 44 UTC. The FDA today launched a comprehensive reassessment of butylated hydroxyanisole…
Europe
Swissmedic Updates Guidelines for Medical Device Maintenance: What You Need to Know
As of January 30, 2026, Swissmedic has updated its guidelines for the maintenance of medical devices, introducing Version 2.1 of…
Europe
Swissmedic Authorises Obgemsa: What It Means for Medical Device Manufacturers
As of 30 January 2026, Swissmedic has granted authorisation for Obgemsa, marking a significant milestone in the medical device landscape.…
Europe
Swissmedic Authorises Alyftrek: What You Need to Know
Alyftrek Receives First Authorisation As of 30 January 2026, Alyftrek has been granted its first authorisation by Swissmedic, marking a…
Europe
Swissmedic Intensifies Market Surveillance of Medical Devices: Key Takeaways for Importers
Swissmedic, the Swiss Agency for Therapeutic Products, has conducted a focus campaign on importers of medical devices, resulting in significant…
Europe
Swissmedic Introduces Mandatory Quality Standards for Pharmaceuticals: What You Need to Know
The Swiss Agency for Therapeutic Products, Swissmedic, has announced a significant shift in the regulatory landscape for pharmaceuticals in Switzerland.…
Europe
Swissmedic Approves Extension of Therapeutic Indication for Nubeqa
PUBLISHED: January 29, 2026 Swissmedic has announced the approval of an extension of therapeutic indication for Nubeqa, a significant development…
Europe
Urgent Medical Device Alert: Arixtra Solution for Injection Pre-Filled Syringes Defect Notification
Published on 2026-01-28, a critical medical device alert has been issued for Arixtra solution for injection pre-filled syringes due to…
Europe
Ocrevus Liver Damage: Swissmedic Update on Ocrelizumab Risks
On January 28, 2026, Swissmedic released a statement regarding Ocrevus (ocrelizumab), a medication used to treat multiple sclerosis. The update…
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