Africa
The new article highlights the aspects related to the classification rules to be applied with respect to in vitro diagnostic medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA) has published a guidance document dedicated...
FDA
The new article describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions. Table of Contents The Food and Drug Administration (FDA or the...
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...
FDA
The new article provides an overview of the guidance document describing the approach to be applied with respect to information the authority expects to be included in submissions for a specific type of product. Table of Contents The Food and Drug Administration (FDA...
IMDRF
The new article highlights the aspects related to the limited support stage of the total product life cycle and provides recommendations to be followed by the parties involved. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary...
FDA
The new article highlights the aspects related to how an applicant should submit requests for feedback and explains the approach to be applied with respect to combination products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
