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, [...]
27 08 2025
27 08 2025
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 [...]
16 06 2025
16 06 2025
510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance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 The new FDA draft guidance seeks [...]
20 05 2025
20 05 2025
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 an [...]
20 05 2025
20 05 2025
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 has [...]
20 05 2025
20 05 2025
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) and [...]
