The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).
The Australian Therapeutic Goods Administration (TGA) is a participating RA, having completed the three year pilot phase of the Program, which ended in December 2016. The TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.
MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.
Find out more about the Program, who is involved and BSI's role now.