FDA
The new article highlights the aspects related to monitoring methods and associated matters.
SAHPRA
The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
Australia
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
FDA
The new article provides an overview of the existing legal framework for the translation of GLP study reports
FDA
The new article provides an overview of the regulatory framework for animal studies involving medical devices.
BfArM
The new article highlights the aspects related to applications for provisional admission for testing.
