ANVISA New Medical Device Regulation RDC 751/2022
On March 1st, 2023, the new RDC (Resolution of the Collegiate Boa...
EU Annual Report on Clinical Evaluation (CECP)
The European Commission (EC) published its first annual report ab...
UK MHRA Extending Acceptance of CE Devices
The Medicines & Healthcare products Regulatory Agency (MHRA),...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, May 2023
USA (FDA) | EUROPE | FINLAND (FIMEA) | SPAIN (AEMPS) | UNITED KIN...
BioPharma – USA/Europe/Asia Regulatory Updates, June 2023
USA | EUROPE | ASIA
USA FDA Issues Development Program Guidances ...
Adverse Event Reporting in UK – SaMD
Any event which meets these three reporting criteria is considere...