Regulatory Focus™ > News Articles > TGA Agrees to Device Single Audit Pilot with Brazil, Canada and US

TGA Agrees to Device Single Audit Pilot with Brazil, Canada and US

Posted 22 October 2013 | By Louise Zornoza

Australia's Therapeutic Goods Administration (TGA) soon plans to launch the Medical Device Single Audit Program (MDSAP) pilot along with Brazil's Anvisa, Health Canada and the US Food and Drug Administration (FDA).

The pilot, set to begin in January 2014, is designed to ensure recognition of a single audit of a medical device manufacturer by all of the participating countries. The pilot also includes the use of third party auditors, which allows greater coverage in auditing manufacturers as opposed to relying solely on the government resources of individual countries. 

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.


TGA Statement

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