Australia
The new article provides a brief overview of the regulatory status of active medical devices by TGA, the regulatory agency of Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
FDA
This article describes in detail the approach to be applied with respect to computational modeling and engineering analysis to be conducted in the course of non-clinical testing of the products in order to assess their materials and characteristics. Table of Contents...
MHRA
This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved. Table of Contents The Medicines and Healthcare Products Regulatory...
Australia
The new article highlights the aspects related to the review procedures, and emphasizes the involvement of the administrative tribunal. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
United States
The new article highlights aspects related to clinical outcomes to be used in the context of studies involving devices intended to treat opioid use disorder. In particular, the article describes in detail the change in drug use as one of the possible clinical outcomes...
Asia
The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to...
