Medical Device Single Audit Program

Medical Device Single Audit Program

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Medical Device Single Audit Program
Medical Device Single Audit Program
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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.

 

MDR QMS deadline 2023

Time for your MDR application is now

According to Amending Regulation (EU) 2023/607, if you are transitioning to the MDR, you will be able to benefit from extended validity of your directive certificates for legacy devices if some conditions are met.

Among these, by 26 May 2024 you have to put in place an MDR compliant QMS and lodge a formal application with a Notified Body for MDR Conformity Assessment.

Apply now
Download the transition guidance

Which markets are part of 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:

Australia flag

Australia

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 Therapeutics Goods Administration >
Brazil flag

Brazil

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.

The Brazilian National Health Surveillance Agency >
Canada market access

Canada

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.

Health Canada >
United States market access

United States

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.

U.S. Food and Drug Administration’s Center for Devices and Radiological Health >

Medical Device Single Audit Program process

Based on a three year audit cycle

MDSAP is based on a three year audit cycle

MDSAP resources to support you

BSI and MDSAP: our commitment to excellence

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