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
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510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance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 The new FDA draft guidance seeks [...]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 [...]
15 04 2025
15 04 2025
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 important [...]
15 04 2025
15 04 2025
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, dedicated [...]
15 04 2025
15 04 2025
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 March [...]
19 03 2025
19 03 2025
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) introduced [...]
