TGA Guidance on Systems and Procedure Packs: Overview
The article overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
The article overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
The new article describes in detail the key points related to the regulatory requirements applicable to the specific groups of products, namely medical systems and procedure packs.
The new article clarifies the particular conformity assessment procedure to be applied in the context of medical device systems and procedure packs.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid...