Mexico: A Summer of Regulatory Overhaul
Translated with AI Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection against [...]
23 09 2025
23 09 2025
23 09 2025
23 09 2025
EU: MDR Language Requirements Tables Updated
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for manufacturers." [...]
27 08 2025
27 08 2025
Medical Advertising in Italy: The New Guidelines
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, [...]
27 08 2025
27 08 2025
IVD Software Qualification: The Team-NB Guide
Translated with AI The Team-NB, the European association of Notified Bodies for Medical Devices, published the second version of its Position [...]
27 08 2025
27 08 2025
Switzerland: UDI Module Activated and Requirements for Procedure Packs
Translated with AI Following the non-extension of the Mutual Recognition Agreement (MRA) with the European Union on May 26, 2021, Switzerland [...]
31 07 2025
31 07 2025
Mexico Opens the Door: Shortened Registration for Medical Devices With International Approval
Mexico strengthens its commitment to simplify access to the Medical Devices market. With the publication of Acuerdo nel Diario Oficial de [...]
17 07 2025
17 07 2025
Medical Device Apps: Who Is Responsible? MDCG Guide 2025-4 Provides Clarity
In the field of digital health, Medical Device Software (MDSW) apps are increasingly popular, used by patients and healthcare professionals to [...]
17 07 2025
17 07 2025
Regulation (EU) 2025/1234 Extends eIFUs to All Devices for Professional Use
Instructions for Use (IFU) are a key component of medical device labelling in the European Union, essential for product safety and [...]
16 06 2025
16 06 2025
Vietnam: End of Derogations for Import Licences as of July 1, 2025
The medical device sector in Vietnam has been the focus of significant regulatory reform in recent years. Decree No. 98/2021/ND-CP, in [...]
16 06 2025
16 06 2025
The UDI System for Medical Devices in Australia: News and Key Deadlines
March 24, 2025, marks a milestone for the medical device industry in Australia: on this date, the Unique Identification of [...]
