Malaysia
The new article highlights the aspects related to different changes to establishment license including, inter alia, changing or adding type of a license, making changes to the name of the entity or the address where the premises are located. The Medical Devices...
Australia and Oceania
The new article highlights the aspects related to study protocols for post-approval studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
Brazil
The new article provides additional clarifications regarding the regulatory status of software products with different types of supply, including software to be installed, cloud solutions, and complex products composed of multiple elements. Table of Contents The...
Australia and Oceania
The new article describes in detail the aspects related to the content of deficiency letters, their review, as well as the way the authority expects the industry to respond to such letters. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
EU MDR/IVDR
The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
Australia and Oceania
The article provides an overview of the regulatory requirements related to handling post-approval studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
