C17 – The Regulation, Reimbursement and Challenges of Companion IVDs

The regulation of companion IVDs in Australia differs from the regulation of these products internationally, e.g. EU – In Vitro Diagnostic Directive (IVDD); US – Federal FD&C Act and relevant medical device regulations etc.  This session aims to look at companion diagnostics from a global perspective including both the regulatory and reimbursement implications and complexities.


Chairperson: Alexandra Mactavish, Merck Serono