Blog
Adopting a Life Cycle Approach to Sof…
In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority…
Medical Devices – USA, Europe, Asia a…
USA
Accreditation Scheme for Conformity Assessment (ASCA)
The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) …
Medical Devices – Europe, Asia…
EUROPE
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
The Commission, after consultin…
USA/Europe Med Device Regulatory 2023…
BELGIUM
Federal Agency for medicines and health products (FAMHP) has released a notice on Deadlines for the submission of dossiers during the end-of-year period
During …
Recap 2023 : Key Medical Device Regul…
ASIA
CHINA
Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligen…
Medical Devices-USA/Europe Regulatory…
USA
Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
Guidance describes a…
