Guidance on certification audits for medical devices

4 August 2017

The TGA Guidance on licensing/certification inspections has been replaced by Australian manufacturing licences and overseas GMP certification : a step-by-step guide in July 2017. This new guidance only applies to manufacturer inspections for medicines and biologicals.

The Medical Devices Branch is developing new guidance specific to medical devices, and the previous guidance document will still be available in the TGA internet site archive while new guidance is being developed:

Domestic and overseas medical device manufacturers who have been notified of an upcoming QMS audit can seek further information on their responsibilities by contacting: