EDA
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.
EDA
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.
FDA
The new article describes in detail special considerations related to remanufacturing medical devices and the determination of the legal status of such activities.
FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
FDA
The new article provides a general overview of several examples demonstrating the way the regulatory approach described in previous articles should be applied.
ARTG
The article highlights the key points related to the regulatory requirements for in vitro diagnostic (IVD) medical devices manufactured by healthcare institutions to address their internal needs.
