In April 2025, the South African Health Products Regulatory Authority (SAHPRA) announced, with an official press release, its membership as an [...]
With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea has [...]
The European Commission has recently updated the list of harmonised standards to support compliance with the MDR(EU) Regulations 2017/745 (EU) and [...]
With the adoption of Regulation (EU) 2025/327 the European Union has officially established the European Health Data Space (EHDS), introducing important [...]
On March 18, 2025, the Commission's Directorate-General for Health and Food Safety published Revision 4 of MDCG Guidance 2020-16, dedicated [...]
The IMDRF (International Medical Device Regulators Forum), an international cooperation body promoting the harmonisation of medical device regulation, published on March [...]
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) introduced [...]
Switzerland: Updates on Safety Measures and IVD Labelling The regulatory environment in Switzerland is evolving to strengthen both the safety [...]
Italy: First NIS2 Fulfilments for Cybersecurity The Legislative Decree 138/2024 , which was published in the Official Journal on October [...]
IVDR Transition: Australia and Switzerland Align With the European Union In recent years, both Australia and Switzerland have taken significant steps [...]
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