Brazil
The new article addresses aspects related to the regulatory requirements for the importation of medical device accessories, as well as combination products and refurbished medical devices. Table of Contents The Brazilian regulating authority in the sphere of...
FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
Brazil
The article provides an overview of the applicable regulatory requirements in the sphere of importation of medical devices the parties involved should comply with to be allowed to undertake such activities. Table of Contents The Brazilian regulating authority on...
Africa
The new article describes in detail the approach to be applied with respect to in vitro diagnostic medical devices, provides an overview of the classification principles, and highlights the key points to be considered in this respect. Table of Contents The South...
Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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