TGA Guidance on Conformity Assessment Certification Applications
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
The article provides a general overview of the regulatory framework for medical devices with measuring functions.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable...