EUROPE: published guideline on borderline devices according to MDR and IVDR
The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices [...]
The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices [...]
On September 28, 2022, the two decrees for the adaptation of Italian regulations to the provisions of MDR (EU) 2017/745 and [...]
It may be difficult for a medical device company to choose the right partner and achieve its marketing goals, especially if [...]
In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is considering [...]
On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested only [...]
The SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs) announced a one-year postponement [...]
The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to check [...]