Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows recognised Auditing Organizations to audit medical device manufacturers in a single program that satisfies the requirements of the participating regulatory authorities.

The program is based on ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes, and the participating regulatory authorities share resources to manage the program.

Our role in MDSAP

We have participated in the MDSAP since 2012 when it started as an International Medical Device Regulators Forum (IMDRF) work item.

We assess MDSAP audit reports and certificates as part of the evidence that sponsors and manufacturers need to comply with medical device regulatory requirements. Further details are in our Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) guidance.

We usually will not audit manufacturers who have been audited under MDSAP. However, we reserve the right to audit any manufacturer supplying medical devices to Australia if necessary.

We need the MDSAP certificates and audit reports to state that the manufacturer was assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002. 

Further details about MDSAP certificate requirements are in MDSAP AU P0026 Certificate Document Requirement of the United States Food and Drug Administration (FDA) website.

MDSAP questions and feedback

You can read the Frequently Asked Questions for the MDSAP, for sponsors and manufacturers. 

Please email us at MDSAP@tga.gov.au with any feedback or questions about MDSAP.

Additional information on MDSAP, including policies, procedures, forms and FAQs, is available on the MDSAP page of the FDA website. 

Medical Device Firms and Auditing Organizations participating in MDSAP are also invited to provide feedback through targeted surveys accessible from the FDA website.