What is a MDSAP audit?

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating Regulatory Authorities (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.

MDSAP audits can be performed by a recognized MDSAP AO, such as BSI. We have been active from the inception of the MDSAP pilot phase and have now completed significant numbers of MDSAP audits, predominantly from world-leading medical device manufacturers.

Which geographies and Regulatory Authorities are included in MDSAP?

MDSAP should be considered for companies based globally, if they wish to export products into the countries participating, as described below. The five RAs involved with MDSAP have made the following statements on how they will utilize MDSAP reports:

Medical Device Single Audit Program process

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