The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.
According to Australia’s Therapeutic Goods (Regulations) 2002, eight types of IVDs fall under the application audit requirements:
- Non assay-specific quality control materials for monitoring Class 4 IVDs
- IVDs for self-testing applications
- IVDs for point-of-care testing
- Class 3 IVDs for detecting sexually transmitted agents
- IVDs to monitor treatment of infections diagnosed with Class 4 devices
- IVDs supplied for use according to the pharmaceutical benefit scheme
- IVDs used in national screening programs
- IVDs whose original manufacturing evidence does not fully satisfy Australian conformity assessments
IVD manufacturers and their sponsors whose products do not qualify for the mandatory audit requirements, however, should not consider themselves off the hook. The TGA also has the authority to select applications for such devices for non-mandatory audits, as well. In either case, the TGA will send written request to the sponsor for information necessary to conduct the application audit.
An application audit by the TGA will entail review of a manufacturer’s technical documentation; any data or documentation deemed by the regulator to be relevant to demonstrable compliance with safety and performance Essential Principles, conformity assessment procedures or advertising or supply information is fair game.
Sponsors should not submit application audit documentation until the TGA formally requests that information, advises the regulator’s website.
