Brazil
The new article addresses aspects related to the way eligibility for registration should be determined. Table of Contents The Brazilian regulating authority in the sphere of medical devices (ANVISA) has published a guidance document dedicated to the importation of...
FDA
The new article addresses the aspects related to the description of functionality and intended use to be included in the submission in the context of patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
IMDRF
The new article highlights the aspects related to the “End of Support” stage of the total product life cycle and outlines the key points to be taken into consideration at this stage in order to ensure the proper performance of medical devices as well as the safety of...
FDA
The new article describes in detail the approach to be applied with respect to meetings under the Q-Submission program and also clarifies the way unique numbers are assigned to incoming requests in order to ensure traceability. Table of Contents The Food and Drug...
Europe
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....
FDA
The new article highlights aspects related to the content of the submission in the context of patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
