EDA
The new article pays special attention to the classification of recall actions taken in order to ensure the continuous safety of medical devices allowed for marketing and use in the country.
EDA
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.
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.
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