Europe
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...
FDA
The new article highlights aspects related to the second stage of the application review process and also describes the approach to be applied when making changes to a tool after its qualification. Table of Contents The Food and Drug Administration (FDA or the...
Brazil
The new article highlights aspects related to the importation process and documentation to be submitted by an interested party. Table of Contents The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published updated guidance dedicated...
FDA
The new article describes in detail the matters related to MR compatibility and also provides a brief overview of non-clinical testing and the way it should be conducted. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Australia and Oceania
The new article highlights aspects related to the application review process and regulatory decisions the authority will make based on its assessment. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
FDA
The new article addresses aspects related to the initial proposal and the way it will be assessed by the authority during the acceptance review. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
