Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
The new article provides additional details on the application process to be followed by the entities interested in designation as conformity assessment bodies, as well as the assessment process associated thereto.
The article outlines the key points associated with the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in Australia.
The new article describes certain specific aspects related to the regulatory framework for the designation of conformity assessment bodies in terms of regulatory requirements applicants should meet.
The article highlights the key points related to the regulatory framework for conformity assessment bodies designated to undertake the relevant procedures in Australia.
ANVISA
