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 Medical Device Single Audit Program audit?

Through MDSAP, medical device manufacturers need only to be audited once in order to comply with the standard and regulatory requirements of up to five different medical device markets.
 
These are; Australia, Brazil, Canada, Japan and United States. Audits are conducted by Auditing Organizations (AO), such as BSI, and authorized by MDSAP member Regulatory Authorities (RA). BSI is an Auditing Organization for MDSAP. Here at BSI, we also offer MDSAP in combination with CE, UKCA, ISO 13485 and ISO 9001 assessments. We have been active since MDSAP's inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs.

 

Medical Device Single Audit Program process

Based on a three year audit cycle

MDSAP is based on a three year audit cycle

BSI is a recognized AO providing QMS certification through MDSAP.

We are also a Conformity Assessment Body for EN ISO 17021-1 as accredited by the Dutch Accreditation Council & UK Accreditation Service. We offer:

Preparation support

Ensuring product development meets regulatory requirements is essential. At BSI, we provide training to support you through the application process.

BSI Group Americas inc. is a recognised Auditing Organization

In addition to the 5 MDSAP member countries, the MDSAP affiliate members utilize the reports and certificates for market entry.

Seamless Transfer

We can offer a seamless transfer service with comprehensive support and the absolute minimum level of disruption.

Which markets are part of MDSAP?

MDSAP is indicated for global manufacturers looking to export their medical devices into different countries participating in the program. These are:

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 >

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

How do I apply for MDSAP?

For clients holding ISO 13485, BSI can roll the MDSAP audit into the existing certification cycle.

Contact us for more information on how to apply for MDSAP.

Call us on +44 345 080 9000

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