News for Economic Operators: Incident Guideline and Registration Form
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document that [...]
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document that [...]
On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the 'Guidance on standardisation for [...]
On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation on [...]
COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical device, [...]
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, [...]