Australia and Oceania
The new article provides additional clarifications regarding the way two medical devices could be compared for the clinical evidence to be used in a new marketing application. Table of Contents The Therapeutic Goods Authority (TGA), an Australian regulatory agency in...
Australia and Oceania
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
Australia and Oceania
The present article describes in detail the regulatory approach to be applied concerning clinical evidence related to custom-made medical devices and also highlights certain other aspects related to clinical evidence submitted in the context of applying for marketing...
Australia and Oceania
The new article describes in detail the regulatory requirements to be applied for clinical evidence for adaptable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products,...
Australia and Oceania
The new article describes in detail specific aspects to be considered for clinical evidence to be submitted for patient-matched medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare...
