Australia’s Therapeutic Goods Administration (TGA) released guidance outlining its latest thinking on how laboratories can meet the country’s regulatory requirements for in-house in vitro diagnostics.
The TGA defines an in-house IVD as a pathology test that has been developed or modified within a laboratory to carry out testing on human samples in order to assist in clinical diagnosis and decision making.
The agency established the new IVD regulatory framework in July 2010 and the transition period for compliance ended on June 30, 2017.
Laboratory networks that use IVDs must operate under a single quality management system (QMS) that is centrally managed and applied at all work locations that manufacture or use in-house IVDs. Management review, internal quality audits, corrective and preventative action, complaints and changes to documentation must all be managed centrally under the QMS.