In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), [...]
As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on authorisations [...]
Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe since [...]
With the Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006, the European Commission [...]
On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published "Essential Principles of Safety and Performance of Medical [...]
Thema CORP, the US-based Thema subsidiary, is pleased to announce its recent membership in the Philadelphia Chamber of Commerce and LSPA, [...]
On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing Practice [...]
In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan for [...]
On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union - EUR-Lex (Regulation (EU) [...]
On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of medical [...]
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