Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is designed and developed to cover relevant requirements from the Regulatory Authorities participating in the program.

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Key Benefits

Meet Regulatory Requirements

Minimise business impacts through a single audit program in lieu of multiple separate audits by the participating regulatory authorities.

Access New Markets

When certifying to the MDSAP, you enable regulatory access to sell your device in Australia, Brazil, Canada, Japan and the United States.

Demonstrate Commitment to Quality

MDSAP provides a comprehensive quality management system focused on areas directly impacting safety, performance and reliability in the medical device lifecycle.

Protect Consumer Safety

Embed a robust risk management framework throughout all processes in the medical device lifecycle to ensure consumers receive safe and reliable products.

What Is It?

The MDSAP model allows recognized Auditing Organizations to conduct a single audit that satisfies compliance requirements and regulatory requirements of participating authorities. This means that the MDSAP audit report can substitute routine agency inspections.

Ending its pilot phase and becoming fully implemented in January 2017, the Medical Device Single Audit Program (MDSAP) is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Agência Nacional de vigilância sanitária (ANVISA), Health Canada (HC), United States Food and Drug Administration (FDA) and Japan’s Ministry of Health Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).The implementation of MDSAP consists of three key stages, including the initial audit (stage 1 and 2), surveillance audits and recertification audit.

Initial Audit

The initial certification audit consists of a Stage 1 and Stage 2 audit.

In the Stage 1 audit, the auditor will review documentation, and evaluate your preparedness for the Stage 2 audit.

The Stage 2 audit determines whether all ISO 13485 and regulatory requirements are met. It evaluates the implementation and effectiveness of your quality management system.

Surveillance Audit

Surveillance Audits are conducted between the Initial and Recertification Audit, to assure that all applicable requirements are continually being met. These audits are generally conducted 12 months apart.

Re-Audit

A Re-audit, or Recertification Audit, is conducted every three years to confirm the continued relevance, applicability and suitability of the organisations quality management, and that it meets all applicable requirements.

Re-audits do not require a Stage 1 audit, unless significant changes have occurred since the last audit.

Special Audits

These audits are not part of the planned audit cycle. These audits are generally conducted when an application for the extension of scope is submitted. They can also be used to investigate significant complaints or non-conformities.

Unannounced Audits

Unannounced Audits are conducted by Auditing Organisations when the regulatory authority detects high grade non-conformities.

Non-Conformities

Non-conformities are based off a grade or score ranging from 1-5. This is calculated in a two step grading system.

The first step grades between 1 to 4 based off the indirect or direct impact. The second step adds an additional grade if there is a lack of documented process, and/or a release of a non-conforming medical device.

Applicable Regulatory Authorities

The five Regulatory Authorities participating in the MDSAP include:

Canada

As of January 1, 2019, Health Canada only accepts an MDSAP certificate for Class II, III and IV medical devices. Health Canada has made the MDSAP mandatory for regulatory submission.

United States

The MDSAP can be used as a substitute to an FDA inspection, however it does not apply to “For Cause” or “Compliance Follow-up”inspections.

Australia

The TGA can accept the MDSAP report as part of the evidence required for compliance with ISO 13485, and may request additional documents.

Brazil

If a previous ANVISA inspection is deemed satisfactory, the MDSAP report can be used as an alternative to an ANVISA inspection.

Japan

The MDSAP audit report is used as a trial to exempt some manufacturers from on-site inspections.

Next Steps

We can help your organisation certify to the Medical Device Single Audit Program.

Start

If you have pending questions, review the MDSAP FAQs

Implement

Contact SAI Global to discuss requirements, timeframes and costs
Perform an optional pre-assessment
Perform a gap analysis

Certify

Undertake a Stage 1 audit
Complete a detailed Stage 2 audit
Upon successful certification, display the ‘Five Ticks’ StandardsMark™
Regulatory notification of successful achievement of MDSAP

Maintain

Conduct annual Surveillance Audits
Recertify to the MDSAP + ISO 13485 every three years
Establish a continuous improvement culture

Optimise

Market for brand and promotional benefits
Optimise commercial teams
Ensure shareholder and stakeholder awareness

Learn Your ABCs of MDSAP

During this webinar we’ll discuss the key differences between MDSAP Audits and ISO 13485 QMS Audits.

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