
TGA Guidance on Notifications for Patient-Matched / Custom-Made Devices: Overview
The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
The new article explains the approach to be followed in the context of retention and management of electronic records.
The article highlights the key points related to the use of electronic records based on the applicable legislation.
The article outlines the basics of the existing Turkish regulatory framework for the distribution of medical devices.
The new article provides additional clarifications regarding certain specific regulatory aspects, including the applicability of the marketing legislation.