Laboratories that perform HBV testing and that claim Medicare Benefits:
- must be accredited for medical testing in accordance with ISO 15189, National Pathology Accreditation Advisory Council (NPAAC) standards and NATA rules and regulations
- must be enrolled, participate and demonstrate acceptable performance continually in appropriate external quality assurance programs (EQAS)
- should contribute testing statistics to National Serology Reference Laboratory (NRL) to ensure the completeness of test denominator data
- should report any adverse events to both the IVD sponsor and the TGA
The TGA has regulatory responsibility for IVDs through the Therapeutic Goods Act 1989 14 and Therapeutic Goods (Medical Devices) Regulations 2002.51 All commercially supplied IVDs must be listed on the ARTG. Before inclusion on the ARTG, all commercially supplied IVDS are evaluated to ensure they are safe and perform as intended. For regulation of HBV IVDs refer to the TGA website In vitro diagnostic medical devices: http://www.tga.gov.au/industry/ivd-guidance.htm
IVD manufacturers, sponsors and the TGA have the responsibility for post-market monitoring of the IVDs. The manufacturer and sponsor must inform the TGA of all reportable adverse events. Corrective action must be initiated by the manufacturer and sponsor of an IVD in consultation with the TGA. This action must occur as soon as practicable after becoming aware of information relating to any adverse events, malfunction or deterioration in the performance, or inadequacy in the design production and labelling of an IVD. Users are encouraged to report any adverse event to the TGA through the Medical Device Incident Reporting and Investigation Scheme as well as to the sponsor of the IVD.52