The MDSAP Harmonization Dream Deferred

Why regulatory harmonization remains the ultimate goal despite current audit-focused approach

When the Medical Device Single Audit Program (MDSAP) emerged from the International Medical Device Regulatory Forum (IMDRF), it carried ambitious promises of transforming global Medical Device regulation. 

Yet today, as auditing organizations and manufacturers navigate the complexities of multi-jurisdictional compliance, a fundamental question persists: Has MDSAP delivered on its original harmonization vision, or has it simply made separate regulatory requirements more efficiently auditable?

On the recent AKRA TEAM webinar, Matteo D'Angelo, an experienced auditor, observed: "What truly needs to happen, in my opinion, is a greater harmonization of these regulatory requirements. That would make things easier, not only for manufacturers, but also for auditing organization. While MDSAP doesn't change the audit framework, one of its foundational objectives has always been harmonization."

Distinct Regulatory Pathways

Today's MDSAP operates more as an audit harmonization tool than a regulatory harmonization mechanism. While manufacturers benefit from a single audit covering multiple jurisdictions, they still must navigate distinct regulatory pathways in each of the five participating countries: Australia, Brazil, Canada, Japan, and the United States.

The program successfully unified the audit process but left the underlying regulatory differences largely intact.

This reality becomes apparent when examining specific requirements. For instance, 21 CFR Part 820 in the United States differs significantly from Health Canada's Medical Device Regulations, even though both are assessed within the same MDSAP audit framework.

The Shift from Harmonization to Audit Efficiency

The evolution from the Global Harmonization Task Force (GHTF) to the IMDRF marked a subtle but significant shift in priorities. 

While harmonization remained a stated objective, practical implementation focused heavily on audit efficiency and reducing regulatory burden through consolidated assessments.

The MDSAP Audit Approach document exemplifies this shift. It provides detailed guidance on conducting unified audits while acknowledging that jurisdictional differences require separate consideration during the assessment process.

MDSAP is a sophisticated audit coordination mechanism rather than a regulatory harmonization catalyst.

This approach delivered immediate benefits to manufacturers facing multiple regulatory audits. However, it also institutionalized the acceptance of regulatory differences rather than driving toward their elimination.

Benefits of True Regulatory Harmonization

True regulatory harmonization would extend far beyond audit consolidation. 

Manufacturers could develop single regulatory strategies applicable across all participating jurisdictions, significantly reducing compliance complexity and costs.

Consider adverse event reporting requirements, which vary dramatically across MDSAP countries in terms of timing, content, and submission processes. Harmonized requirements would eliminate the need for jurisdiction-specific reporting systems and reduce the risk of non-compliance due to conflicting requirements.

Harmonized regulations would transform Medical Device development from a jurisdiction-by-jurisdiction approach to a truly global strategy.

ISO 13485:2016 provides a foundation for such harmonization, but its generic nature requires significant interpretation and supplementation by local regulations. True harmonization would build upon this foundation with consistent implementation guidance across jurisdictions.

Challenges Preventing Harmonization Progress

Several fundamental obstacles continue to impede meaningful regulatory harmonization. 

National sovereignty concerns top the list, as countries remain reluctant to cede regulatory authority to international bodies, even when potential benefits are clear.

Legal and constitutional frameworks also create barriers. The U.S. system, governed by 21 CFR Parts 800-898, reflects decades of American regulatory evolution, while the European Union's Medical Device Regulation (MDR) embodies different philosophical approaches to risk management and market oversight.

Each regulatory system reflects unique cultural, legal, and historical perspectives on Medical Device safety and efficacy.

Political and economic considerations further complicate harmonization efforts. Countries view regulatory requirements as tools for protecting domestic industries and maintaining competitive advantages, creating resistance to standardization that might benefit foreign competitors.

There are also practical implications of true regulatory harmonization. 

The infrastructure associated with many of the activities, such as receiving communication about serious incidents involving patient death or harm for example, and the subsequent review of this information by a regulatory oversight function would need to be consistent in all regions. Such infrastructure would include trained staff using the same forms, databases, and systems to process the data. Language differences would further complicate the development of a uniform system. 

Impact on Manufacturers and Auditing Organizations

The current state of partial harmonization creates ongoing challenges for both manufacturers and auditing organizations. 

Manufacturers must maintain multiple quality systems or develop complex matrices to track jurisdiction-specific requirements within unified systems.

Auditing organizations face the technical challenge of assessing compliance with fundamentally different regulatory frameworks within a single audit process. This requires auditors with expertise across multiple jurisdictions and the ability to switch between different regulatory contexts during assessments.

The complexity of managing multiple regulatory frameworks within a single audit creates significant training and resource challenges for auditing organizations.

Small and medium-sized manufacturers particularly struggle with this complexity, often lacking the resources to maintain separate regulatory expertise for each jurisdiction. This creates barriers to global market access that true harmonization could eliminate.

Future Prospects for Regulatory Alignment

Despite current challenges, several trends suggest renewed momentum toward regulatory harmonization. 

The IMDRF's continuing work on guidance documents demonstrates ongoing commitment to convergence, even if progress remains incremental.

The recent expansion of MDSAP observer participation, including representatives from the European Union, Singapore, and the United Kingdom, suggests growing international interest in harmonized approaches. These observers provide valuable perspectives on alternative regulatory models and potential pathways toward greater alignment.

Observer participation creates opportunities for learning and gradual convergence that may not have existed in purely bilateral regulatory relationships.

Technological advances in medical devices, particularly software-based and AI-enabled products, are creating new regulatory challenges that all jurisdictions must address. This shared challenge creates opportunities for collaborative solution development and potential harmonization.

Steps Toward Achieving Harmonization Goals

Achieving meaningful regulatory harmonization will require sustained commitment from all stakeholders. 

The IMDRF should prioritize developing specific harmonization roadmaps with measurable milestones rather than maintaining broad harmonization as an aspirational goal.

Pilot programs focusing on specific device categories or regulatory areas could demonstrate harmonization benefits and build momentum for broader initiatives. These pilot programs should include measurable outcomes for both regulatory efficiency and patient safety.

Successful harmonization requires moving beyond broad policy statements to specific, actionable initiatives with clear success metrics.

Industry engagement will prove crucial for maintaining momentum. Manufacturers must continue advocating for harmonization while demonstrating willingness to adapt existing systems to support aligned regulatory approaches.

The MDSAP experience provides valuable lessons about the challenges and opportunities in regulatory harmonization. While the program successfully demonstrated that coordinated auditing is possible, it also revealed the deep-seated obstacles to true regulatory convergence.

Moving forward, stakeholders must decide whether to accept MDSAP's current audit-focused approach as sufficient or to pursue more ambitious harmonization goals. The choice will significantly impact the future of global medical device regulation and the accessibility of life-saving technologies worldwide.

True harmonization remains both achievable and essential for advancing global health outcomes. The question is whether the regulatory community has the vision and commitment to make it a reality.