EDA Guidance on Reporting Adverse Reactions: Minimum Criteria
The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
The new article highlights the aspects related to the form and manner of reporting, responsible parties, as well as procedures and activities associated with reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the...
The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical devices and also describes the applicable reporting timelines. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a Questions-and-Answers document dedicated to the Electronic Medical Device Reporting (eMDR). The document is intended to provide...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...