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 non-clinical performance testing for patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory authority in the sphere of healthcare products, has published a guidance...
Europe
The new article highlights aspects related to the information to be included in the submission in order to ensure its completeness. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical...
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...
Europe
The article provides a brief overview of the way medical devices should be registered when placed on the UK market. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has...
FDA
The new article addresses aspects related to information regarding sterilization methods the authority expects medical device manufacturers to provide and also explains the approach to be applied with respect to packaging. Table of Contents The Food and Drug...
