Insulet Voluntary Correction for Omnipod 5 Pods in the U.S.
Insulet issues a voluntary correction for select Omnipod 5 Pod lots in the U.S. due to a tubing tear risk,…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Latest News
Device alert: Erbe Cryoprobe rupture risk
FDA MedWatch warns Erbe USA cryoprobes may rupture during activation, risking hearing loss and injuries. The agency and manufacturer urge…
Latest News
Wound Dressing Device Recall: Integra Removes MediHoney and CVS Products
FDA MedWatch reports a wound dressing device recall by Integra LifeSciences after sterile barrier breaches in MediHoney and CVS Wound…
Europe
Swissmedic Introduces New Authorisation Pathway for Herbal Medicinal Products with Orphan Drug Status
What changed? Swissmedic has introduced a new authorisation pathway for herbal medicinal products with orphan drug status. This change aims…
Europe
Swissmedic Introduces Machine-to-Machine Product Registration: What You Need to Know
What is M2M Product Registration? Starting from the end of March 2026, swissdamed playground will offer Machine-to-Machine (M2M) product registration…
Europe
Swissmedic Sees 17% Rise in Illegal Medicinal Product Imports from the EU in 2025
According to a recent announcement by Swissmedic, there has been a significant increase in the number of illegal imports of…
Europe
Swissmedic Initiates Batch Recall of Verkazia Augentropfen Emulsion
Swissmedic Initiates Batch Recall of Verkazia Augentropfen Emulsion Swissmedic, the Swiss agency for therapeutic products, has initiated a batch recall…
Europe
Swissmedic Clears Record Number of Human Medicinal Products with New Active Substances in 2025
On February 17, 2026, Swissmedic announced a milestone in the authorization of human medicinal products with new active substances and…
Europe
Swissmedic Issues Important Update on Cytosar (Cytarabinum): What You Need to Know
As of February 18, 2026, Swissmedic has released a crucial update regarding Cytosar (Cytarabinum), a medication used in the treatment…
Europe
Swissmedic Clears Ekterly®: A Breakthrough in Medical Devices
Swissmedic has granted its first authorization to Ekterly®, marking a significant milestone in the development of medical devices. As of…
Latest News
FDA Opens PreCheck Pilot to Strengthen Domestic Pharmaceutical Manufacturing
On February 12, 2026, the U S Food and Drug Administration began accepting requests to participate in the FDA PreCheck…
Latest News
FDA Grants First of Its Kind Device Approval for Locally Advanced Pancreatic Cancer
Meta description: The FDA has approved a first of its kind device for locally advanced pancreatic cancer, marking a regulatory…
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