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, [...]
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 [...]
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 [...]
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 [...]
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, [...]
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 [...]
510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance
What happens when you intend to transfer or sell a 510(k) authorisation to another holder? The new FDA draft guidance [...]
SAHPRA Joins MDSAP as an Affiliate Member: New Opportunities for MD Manufacturers in South Africa
In April 2025, the South African Health Products Regulatory Authority (SAHPRA) announced, with an official press release, its membership as [...]
News on South Korea’s K-GMP Regulations for Medical Devices and IVDs
With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea [...]
EU: New Harmonised Standards for Medical Devices
The European Commission has recently updated the list of harmonised standards to support compliance with the MDR(EU) Regulations 2017/745 (EU) [...]
European Health Data Space Regulation (EHDS): New Obligations for Medical Device Manufacturers
With the adoption of Regulation (EU) 2025/327 the European Union has officially established the European Health Data Space (EHDS), introducing [...]
Update of MDCG Guidance 2020-16 on the Classification of IVDs in the EU
On March 18, 2025, the Commission's Directorate-General for Health and Food Safety published Revision 4 of MDCG Guidance 2020-16, [...]
Terminology for Adverse Events in Medical Devices: IMDRF Update, March 2025
The IMDRF (International Medical Device Regulators Forum), an international cooperation body promoting the harmonisation of medical device regulation, published on [...]
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) [...]
Switzerland: Updates on Safety Measures and IVD Labelling
Switzerland: Updates on Safety Measures and IVD Labelling The regulatory environment in Switzerland is evolving to strengthen both the [...]
Italy: First NIS2 Fulfilments for Cybersecurity
Italy: First NIS2 Fulfilments for Cybersecurity The Legislative Decree 138/2024 , which was published in the Official Journal on [...]
IVDR Transition: Australia and Switzerland Align With the European Union
IVDR Transition: Australia and Switzerland Align With the European Union In recent years, both Australia and Switzerland have taken significant [...]
FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs
FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs On January 6, 2025, the FDA [...]
