In Australia, the MDSAP is already established to achieve the goal of a single audit programme for medical device manufacturers and to facilitate market access. The Australian Therapeutic Goods Administration (TGA) has been involved in the MDSAP from the beginning and is prepared accordingly.
The TGA uses the MDSAP audit reports and certificates as part of the required compliance evidence. However, there are some products that may be exempt from this requirement.
In some cases, separate audits by the TGA may not be required if manufacturers have already been audited under the MDSAP. However, this does not mean that the TGA does not conduct its own audits.
For MDSAP certificates and audit reports to be accepted by the TGA, the Australian requirements must be reflected in the reports and the certificates must confirm that the manufacturer has been audited and follows the essential provisions of the Therapeutic Goods (Medical Devices) Regulations 2002.
