MDCG Guidance on Exemptions From Clinical Investigations
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
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.
The article outlines the key points associated with registering healthcare products under the existing legal framework.
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
The article highlights the aspects related to the regulatory framework for telecommunication products, radiation-emitting medical devices as well as the software used to power healthcare products. Table of Contents The Therapeutic Goods Administration (TGA), an...