In an increasingly complex regulatory landscape, medical device manufacturers face growing pressure to meet the quality and compliance requirements of multiple countries. The Medical Device Single Audit Program (MDSAP) was created to streamline this process.
The MDSAP audit approach enables manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple jurisdictions, reducing audit duplication and simplifying market access. By aligning inspection expectations across five major markets, MDSAP offers a unified path to achieving global medical device compliance.
As more countries adopt or recognize the program and with some, like Canada, making it mandatory, the relevance of MDSAP for medical devices is only increasing. For manufacturers seeking to compete internationally, understanding MDSAP is essential.
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What is the MDSAP Audit Approach?
At its core, the MDSAP audit model is built around evaluating a manufacturer’s Quality Management System (QMS) to ensure it meets the regulatory requirements of participating countries. The program is structured to assess compliance using a process-based audit methodology, harmonized closely with ISO 13485:2016, the globally accepted standard for medical device quality management.
This alignment means companies already certified to ISO 13485 will find a solid foundation to build upon for MDSAP. The audit focuses not only on conformance with standards but also on the effectiveness of the QMS, making the approach both comprehensive and performance-based.
Which Countries Participate in MDSAP?
One of the main advantages of MDSAP is that it covers the regulatory needs of multiple key medical device markets through one audit.
As of now, the following countries participate as official members:
- United States (FDA)
- Canada (Health Canada) – MDSAP is mandatory for all Class II and higher devices sold in Canada
- Brazil (ANVISA)
- Japan (PMDA and MHLW)
- Australia (TGA)
These five MDSAP countries represent a significant portion of the global medtech market, and participation in the program can streamline access to them simultaneously.
How the MDSAP Audit Process Works
The MDSAP audit process is broken into five core processes, each focused on a specific area of a manufacturer’s QMS.
These include:
- Management: Reviews top-level oversight, including management reviews, internal audits, and quality planning.
- Device Marketing Authorization and Facility Registration: Confirms that products are registered and marketed legally in each jurisdiction.
- Measurement, Analysis, and Improvement: Evaluates systems for handling complaints, nonconformities, CAPAs, and continuous improvement.
- Design and Development: Assesses how design processes are controlled and whether devices are developed in compliance with safety and performance standards.
- Production and Service Controls: Looks at manufacturing controls, equipment maintenance, process validation, and service activities.
A unique feature of MDSAP is linkage auditing, where auditors examine how processes interact rather than treating them in isolation. For example, a nonconformity found in design controls may also link to management review failures.
MDSAP also uses a grading system for nonconfirmities, assigning severity levels that help regulators determine necessary follow-up actions.
Benefits of MDSAP for Medical Device Companies
The Medical Device Single Audit Program offers clear and measurable benefits for manufacturers seeking efficient, consistent regulatory compliance:
- One audit, multiple markets: Avoid redundant audits from different regulators, saving time and resources.
- Reduced audit fatigue: Minimize disruptions to operations by consolidating inspection efforts into a single, unified process.
- Faster market access: By demonstrating compliance across multiple jurisdictions, companies can reduce regulatory review times and speed up product launches.
- Improved regulatory trust: Participation enhances credibility with global regulators, signaling a proactive commitment to compliance.
For companies pursuing global medical device compliance, MDSAP is not just a shortcut it is a strategic asset.
Challenges and Common Pitfalls
Despite its advantages, preparing for an MDSAP audit can be demanding. These audits are typically longer and more detailed than traditional ones, requiring significant preparation and coordination across teams.
Even companies certified to ISO 13485 may find their QMS doesn’t fully meet the expectations of all MDSAP jurisdictions, creating potential gaps. Documentation is another challenge. Auditors expect complete, well-organized records that demonstrate traceability, effective CAPA processes, and risk management.
Additionally, if minor nonconformities are not addressed properly, they can escalate into larger compliance issues. Addressing these challenges early helps ensure a smoother, more efficient audit experience.
Preparing for a Successful MDSAP Audit
To navigate the audit confidently, medical device companies should take the following steps:
Even companies certified to ISO 13485 may find their QMS doesn’t fully meet the expectations of all MDSAP jurisdictions, creating potential gaps. Documentation is another challenge. Auditors expect complete, well-organized records that demonstrate traceability, effective CAPA processes, and risk management.
- Conduct a gap analysis: Compare your current QMS against MDSAP requirements and ISO 13485 to identify any shortcomings.
- Ensure audit-ready documentation: Organize SOPs, records, and technical files in a way that supports easy access and review during the audit.
- Train internal teams: Educate staff not only on ISO 13485 but on the structure of the MDSAP audit, including expectations of linkage audits and grading.
- Centralize regulatory data: Use quality and regulatory management systems to keep all relevant documentation, actions, and evidence accessible in one place.
- Simulate the audit: Consider running internal mock audits or hiring a consultant to conduct a pre-MDSAP audit assessment.
These steps form the foundation of solid medical device audit preparation and demonstrate a strong internal culture of compliance.
Conclusion
For global manufacturers, the MDSAP audit approach represents a strategic opportunity to streamline compliance, reduce regulatory burden, and expand access to major markets. By undergoing a single, harmonized audit, companies can meet the requirements of five key health authorities with one process saving time, reducing costs, and building trust.
However, success with MDSAP depends on preparation, transparency, and a robust quality management system. Companies that invest in proper planning, documentation, and training will not only pass their audits, they will position themselves as reliable partners in global healthcare delivery.
Author: Taylor Esser
