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).
ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and postmarket assessment procedures. It provides, when applicable, key information that is expected to support regulatory technical evaluation on these issues.
MDSAP Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating RA to audit under MDSAP requirements. MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.