Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is a globally harmonized initiative developed to align and streamline regulatory requirements from participating medical device regulatory authorities.
Today’s medical device industry organizations face intense regulatory scrutiny and evolving compliance demands.
QCI Global supports your journey through MDSAP certification in the global marketplace.
Meet Regulatory Requirements
Through a single comprehensive audit, MDSAP helps organizations meet the expectations of multiple regulatory bodies.
Access New Markets
Achieving MDSAP certification opens regulatory pathways to market your medical devices in Australia, Brazil, Canada, Japan, and the United States, accelerating global market entry.
Demonstrate Commitment to Quality
The MDSAP framework ensures a robust quality management system focused on enhancing product performance, safety, and compliance across the device lifecycle.
Protect Consumer Safety
Embed risk-based thinking and stringent process controls throughout your operations to consistently deliver safe, effective, and reliable medical devices to patients and end users.
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 for 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), the 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 (stages 1 and 2), surveillance audits, and recertification audits.
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 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.
A Re-audit, or Recertification Audit, is conducted every three years to confirm the continued relevance, applicability and suitability of the organizations 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.
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 are conducted by Auditing Organizations when the regulatory authority detects high grade 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.
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 organization certify to the Medical Device Single Audit Program.
Implement
- Contact QCI Global to discuss requirements, timeframes and costs.
- Perform and option 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
Optimize
- Market for brand and promotional benefits
- Optimize commercial teams
- Ensure shareholder and stakeholder awareness
Medical Devices Courses & Training
Explore the range of Medical Devices courses we have on offer through QCI Global Assurance Learning.
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Browse the other products or services that QCI Global Assurance can provide you and your organization.
