How MDSAP Works, and How It Can Streamline Your Audit Process Across Multiple Markets
In the landscape of global medical device regulation, manufacturers face increasing pressure to demonstrate compliance with diverse quality management system (QMS) requirements across multiple jurisdictions. Traditionally, this has meant undergoing separate audits for each market—a process that is both time-consuming and resource-intensive. The Medical Device Single Audit Program (MDSAP) was developed to address these inefficiencies. By harmonising auditing standards across participating regulatory authorities, MDSAP enables a single, comprehensive audit that satisfies multiple market requirements. This paper examines the structure and function of MDSAP, its regulatory framework, and how it can streamline audit processes for medical device manufacturers seeking to maintain global compliance efficiently and effectively.
Overview of MDSAP
The Medical Device Single Audit Program (MDSAP) is an international initiative established by a consortium of medical device regulatory authorities. The program allows a recognised auditing organisation to conduct a single audit of a medical device manufacturer’s QMS that meets the regulatory requirements of all participating markets. The participating regulators include:
Therapeutic Goods Administration (TGA) of Australia
Health Canada
Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
U.S. Food and Drug Administration (FDA)
The World Health Organization (WHO) and the European Union (EU) participate as observers but do not currently accept MDSAP audits as a substitute for their own regulatory audits. The core intent of MDSAP is to create a standardised audit model that supports international harmonisation while maintaining each authority’s regulatory autonomy.
The Framework and Structure of MDSAP
MDSAP is built upon the principles outlined in ISO 13485:2016, the internationally recognised standard for medical device quality management systems. However, MDSAP extends beyond ISO 13485 by incorporating country-specific regulatory requirements. The audit model is structured into a series of seven process-based audit tasks, covering the following:
Management – Ensures leadership commitment, quality policy, and resource allocation.
Measurement, Analysis, and Improvement – Evaluates mechanisms for monitoring product quality and compliance.
Design and Development – Assesses design control and risk management activities.
Production and Service Controls – Reviews manufacturing controls, process validation, and equipment management.
Purchasing Controls – Examines supplier qualification and control of outsourced processes.
Device Marketing Authorization and Facility Registration – Verifies compliance with jurisdictional registration requirements.
Medical Device Adverse Events and Advisory Notices Reporting – Evaluates post-market surveillance, complaint handling, and regulatory reporting.
The program uses a process-based approach aligned with the Plan-Do-Check-Act (PDCA) cycle to assess the effectiveness of the manufacturer’s QMS holistically rather than through isolated procedural reviews. This model provides a comprehensive view of compliance performance and facilitates continuous improvement across all operational areas.
Audit Execution and Oversight
Audits under MDSAP are conducted by authorised third-party organisations known as Auditing Organizations (AOs), which must be recognised by the participating regulatory authorities. These organisations are rigorously evaluated to ensure they operate with impartiality, competence, and consistency. The audits themselves are typically conducted annually, with the initial certification audit followed by surveillance and recertification cycles similar to ISO 13485.
MDSAP audits follow a risk-based approach, meaning that the duration and depth of the audit depend on the complexity of the product and the history of compliance. Findings are categorised according to the severity of nonconformities—major, minor, or opportunities for improvement—each requiring corresponding corrective action. The results are then shared with all participating regulators via a centralised reporting mechanism, reducing the need for redundant submissions.
Benefits of MDSAP for Manufacturers
The most significant advantage of MDSAP is its efficiency. By replacing multiple separate audits with a single harmonised assessment, manufacturers can save substantial time, money, and internal resources. For example, rather than preparing for individual audits from the FDA, TGA, and Health Canada, a single MDSAP audit can fulfil the compliance obligations for all three simultaneously.
Moreover, MDSAP enhances regulatory predictability. Because the audit model is standardised, manufacturers gain clarity regarding expectations and audit scope, leading to fewer surprises and more consistent audit outcomes. This consistency promotes a proactive compliance culture that reduces the likelihood of regulatory enforcement actions.
From a strategic perspective, MDSAP can also improve a company’s market access agility. A manufacturer that completes an MDSAP audit is automatically eligible to market products in all participating jurisdictions without undergoing additional QMS audits. This is particularly beneficial for firms expanding internationally or introducing new product lines, as it eliminates the bottleneck of sequential regulatory audits.
Regulatory Advantages for Participating Authorities
For regulators, MDSAP provides a mechanism for resource optimisation. By leveraging audits conducted by recognised AOs, authorities can focus their internal resources on higher-risk or noncompliant entities. The program also enhances global regulatory cooperation, as data sharing through the MDSAP system fosters greater transparency and consistency in oversight.
Health Canada, for instance, has made MDSAP mandatory for all medical device manufacturers seeking to market products in Canada. This demonstrates a high degree of confidence in the program’s ability to uphold regulatory integrity while reducing administrative duplication. The FDA, while not making MDSAP mandatory, accepts MDSAP audit reports in place of routine inspections, further validating the program’s credibility.
Challenges and Considerations
Despite its benefits, MDSAP implementation presents certain challenges. Smaller manufacturers, in particular, may find the initial cost of transitioning to MDSAP audits higher than expected, especially if they previously focused on a single market. Furthermore, the audit intensity under MDSAP can exceed that of typical ISO 13485 audits, as it encompasses additional jurisdictional requirements and more extensive documentation reviews.
Another limitation is partial market coverage. Since the European Union does not currently participate in MDSAP, companies seeking EU CE marking must still undergo separate conformity assessments. Nevertheless, there are signs of increasing alignment between MDSAP principles and the EU’s Medical Device Regulation (MDR), suggesting potential future integration.
Finally, the success of MDSAP depends heavily on the competence and consistency of Auditing Organizations. Although the recognition process for AOs is stringent, variations in auditor experience or interpretation of regulatory requirements can still occur, underscoring the need for continual oversight and calibration.
The Role of QSN Academy and Quality Systems Now
For organisations navigating the complexities of regulatory compliance, structured training and expert guidance are essential. QSN Academy—the educational arm of Quality Systems Now—provides specialised training and consultancy in Good Manufacturing Practice (GMP) and regulatory compliance for therapeutic goods manufacturers, testing laboratories, and biotechnology companies.
Through targeted MDSAP education programs, QSN Academy helps manufacturers understand the audit model, prepare documentation, and implement corrective actions aligned with global regulatory expectations. This ensures not only readiness for successful audits but also sustainable quality culture within the organisation. Their scientific and evidence-based approach enables clients to adopt MDSAP as an instrument for continuous improvement, rather than merely a compliance obligation.
Conclusion
The Medical Device Single Audit Program represents a significant advancement in the harmonisation of global medical device regulation. By enabling a single, comprehensive audit recognised by multiple authorities, MDSAP streamlines compliance efforts, reduces redundancy, and fosters international trust in quality management systems. While challenges remain—particularly regarding cost, auditor consistency, and partial global coverage—the program offers a clear path toward more efficient and transparent regulatory oversight. For manufacturers seeking to maintain global competitiveness, participation in MDSAP, supported by professional guidance from experts such as QSN Academy, offers both strategic and operational advantages.
