FDA
The article provides a brief overview of the regulatory approach to be applied with respect to certain tests intended to be used in the context of an emergency.
EDA
The new article provides additional clarifications regarding specific aspects associated with recalls, such as appeals to relevant decisions or disposal for medical products.
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.
