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 article highlights the key points related to the regulatory status of boundary products in Australia.
The document outlines the key points related to the applicable classification requirements for specific types of medical devices. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a...