Medical Device Single Audit Program

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.

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:

The Therapeutics Goods Administration (TGA) uses an MDSAP audit report as part of the evidence that it has 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.

The Brazilian National Health Surveillance Agency 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.

Health Canada Health Canada (HC) will ONLY accept MDSAP for manufacturers who market their devices in Canada. Therefore, manufacturers wishing to place a product on the market in Canada need to have MDSAP Certification issued by an AO.

The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both pre-market and periodical post-market audits under regulations in Japan.

U.S. Food and Drug Administration’s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, the MDSAP program would not apply to any necessary pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)
(5)) concerning the classification of a device.

BSI is a fully recognized AO. We supported the MDSAP pilot and have been conducting audits since September 2014. We've experienced increased interest and applications by manufacturers. Feedback about the benefits of MDSAP has been overwhelmingly positive. 

BSI understands the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the resilience and transparency of regulatory clearance is key to maintaining a competitive edge.

We demonstrate this commitment through:

• over 200 MDSAP assessors worldwide
• over 240 QMS ISO 13485 assessors globally
• internal Product Experts and Auditors
• direct access to a team of technical and clinical specialists