EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means [...]
FDA QMSR Explained: What the New Quality System Regulation Means (and How to Prepare)
The wait is over, and the transition window is officially [...]
Swissmedic Announces Medical Device Registration Fees for Swissdamed
Swissmedic has published further details on the registration fees [...]
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise ( Cloned )
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise [...]
New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078? On 17 October 2025, [...]
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare [...]
Swissdamed UDI Devices module: medical device registration now available
On 18 August 2025, Swissmedic launched the new UDI Devices [...]
