Category: Standards

The International Medical Device Regulators Forum (IMDRF) released three final documents covering clinical evaluation of medical devices, in vitro diagnostics and software as medical device products;...

The South African Health Products Regulatory Authority (SAPHRA) invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications using the WHO pre-qualification collaborative...

CHALLENGES:  Abiding by the national laws and regulations is a necessity for biopharma organizations towards the development, manufacture and selling of their pharmaceutical products. Prior...

Luxembourg and the Netherlands were added into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). FDA confirms the ability of...