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.
ARTG
The new article describes in detail the applicable classification rules in-house in vitro diagnostic medical devices are subject to, as well as the relevant regulatory requirements to be applied depending on the classification.
