EDA Guidance on Recalls: Initiation
The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.
The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.
The new article is dedicated to the rapid alert system implemented by the authority in order to ensure the important safety-related information associated with healthcare products allowed for marketing and use in the country is communicated and shared without undue delay.
The new article describes in detail the two subsequent stages of a recall process – implementation and review – and also highlights the key points to be taken into consideration by the parties responsible for a recall at each of the stages.
The article highlights the key points related to the regulatory framework for recalls introduced in Egypt.
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 vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.