FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
Turkey
The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
