Medical Device Single Audit Program

Medical Device Single Audit ProgramThe Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, 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 Auditing Organisations (AO), such as BSI. BSI have been active through the MDSAP pilot phase and have now received significant numbers of applications for MDSAP, predominantly from world leading medical device manufacturers. BSI has performed over 800 MDSAP audits worldwide and issued a significant number of global sites with MDSAP certifications and we are currently processing many more.

FDA guidance on MDSAP can be accessed below:

FDA MDSAP Guidance Documents

View a comprehensive explanatory webinar from the FDA

FDA MDSAP Frequently Asked Questions 

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 RA’s involved with MDSAP have made the following statements on how they intend to utilize MDSAP reports:

  • Australia: The Therapeutics Goods AdministrationTGA 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.
  • Brazil: The Brazilian National Health Surveillance AgencyANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues.
  • Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
  • United States: U.S. Food and Drug Administration’s Center for Devices and Radiological HealthFDA 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, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket 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.
  • Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan.  Japan officially joined the pilot in June 2015.