FDA
The new article describes in detail the applicability scope of the new regulatory policy for laboratory-developed tests.
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.
Australia
The article highlights the key points related to the regulatory framework for conformity assessment bodies designated to undertake the relevant procedures in Australia.
EU
The new article describes in detail the approach to be applied when it comes to the re-assessment of designation under the new regulatory framework.
EU
The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
Canada
The present article highlights the key points related to the changes the Canadian authority intends to introduce in order to mitigate the risks associated with potential shortages in the supply of healthcare products intended to be marketed and used in the country.
