MDSAP: Simplifying Global Compliance

by Jennifer Day

MDSAP, or the Medical Device Single Audit Program, stands as an acronym that resonates across the medical device industry.

But what exactly is MDSAP? It represents the Medical Device Single Audit Program, a pioneering international endeavor.

This program empowers medical device manufacturers to undergo a unified regulatory audit that fulfills the requirements

of multiple regulatory authorities.

A Unified Approach

Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP unites regulatory authorities from Australia, Brazil, Canada, Japan, and the United States. Its overarching objective is to harmonize and standardize the regulatory landscape for medical devices across participating countries. This initiative significantly diminishes the need for redundant audits and assessments.

Advantages for Medical Device Manufacturers

1. Streamlined Auditing Process:

MDSAP condenses the regulatory process by enabling manufacturers to satisfy the criteria of multiple countries with just one audit, eliminating the need for individual audits in each nation.

2. Reduced Regulatory Burden:

Manufacturers can save time, resources, and costs associated with undergoing separate audits and assessments from diverse regulatory authorities.

3. Global Market Access:

Facilitating entry into major markets including Australia, Brazil, Canada, Japan, and the United States, collectively representing a substantial segment of the global medical device market.

4. Consistent Standards:

MDSAP aligns regulatory requirements and audit protocols among participating countries, endorsing a more uniform approach to compliance and quality management.

5. Improved Quality Management:

Manufacturers are encouraged to implement robust quality management systems (QMS) adhering to international standards like ISO 13485. This fosters elevated product quality and patient safety.

6. Risk-Based Auditing:

MDSAP emphasizes a risk-centric approach to auditing, allowing regulatory authorities to concentrate on higher-risk areas within a manufacturer's QMS.

7. Enhanced Communication and Collaboration:

The program cultivates communication and collaboration between regulatory authorities and manufacturers, fostering a more profound understanding of regulatory expectations and requisites.

8. Harmonization of Regulations:

MDSAP contributes to the harmonization of regulatory requirements across participating countries, diminishing disparities and simplifying manufacturers' navigation of international markets.

9. Continuous Improvement:

Through the audit process, manufacturers receive constructive feedback on their quality management systems, providing an opportunity for refinement and ultimately yielding higher quality products.

10. Competitive Advantage:

Manufacturers aligning with MDSAP requirements may gain a competitive edge by exemplifying a dedication to quality and compliance on a global scale.

Standardization and Clarity

MDSAP offers a meticulously standardized system that defines clear expectations between manufacturers and regulatory authorities regarding audit procedures, duration, nonconformance grading, and ensuing actions.

MDSAP Audit Approach Document

The MDSAP Audit Approach Document stands as a comprehensive guide for auditors and participating manufacturers. It ensures audits are conducted uniformly, adhering to established standards and procedures. It categorizes processes within the QMS and delineates specific tasks for assessing conformity.

For further transparency, this document is publicly accessible through the FDA website’s MDSAP Audit Procedures and Forms page. This empowers manufacturers and auditors alike with precise insights into what should be reviewed and assessed during an MDSAP audit.

Determining Audit Duration

MDSAP exercises meticulous control over the duration of audits, taking into account various factors. These include the complexity of the manufacturer's operations, the scope of the audit, and the size of the organization. The key considerations in duration determination include:

1. Size and Complexity of the Manufacturer:

Larger or intricately structured organizations may require extended audit durations to thoroughly assess all pertinent areas of their quality management system (QMS) and regulatory compliance.

2. Scope of the Audit:

The audit's scope defines the extent of the manufacturer's operations under evaluation. A broader scope encompassing multiple sites or an extensive range of products may necessitate a more prolonged audit duration.

3. Number of Sites and Locations:

Manufacturers with multiple sites or facilities may require additional time for on-site inspections and the assessment of quality management systems at each location.

4. Range of Products and Processes:

Manufacturers producing a diverse array of medical devices or involved in complex manufacturing processes may necessitate more time for a comprehensive evaluation.

5. Regulatory Requirements of Participating Countries:

Specific regulatory requirements of participating countries may influence the depth and breadth of the audit, potentially affecting its duration.

6. Risk-Based Approach:

The risk assessment performed by the audit team may guide the allocation of time to higher-risk areas, potentially affecting the overall audit duration.

7. Cooperation and Accessibility of the Manufacturer:

The readiness and cooperation of the manufacturer during the audit process can significantly contribute to the efficiency of the assessment.

Ultimately, the audit team determines the audit duration based on a judicious consideration of these factors. Effective communication and collaborative efforts between auditors and manufacturers are crucial to ensure the audit is comprehensive and conducted efficiently.

Nonconformance Grading in MDSAP Audits

Distinct from other audits, MDSAP rigorously controls the grading of nonconformities. All findings are assessed on a scale of 1 to 5. Nonconformities graded as 4 or 5 are deemed critical findings and are promptly reported to the relevant regulatory authorities. Four factors influence the grading of nonconformities.

1. Impact on Quality Management System (QMS):

Nonconformities are stratified based on their impact, categorized as either indirect or direct QMS impact.

a. Indirect QMS Impact:

Pertains to clauses considered "enablers" for the QMS, indirectly influencing medical device safety and performance. (ISO 13485:2016 clauses 4.1 through 6.3 (except 4.2.3))

b. Direct QMS Impact:

Relates to clauses with a direct influence on design and manufacturing controls, directly affecting medical device safety and performance. (ISO 13485:2016 clauses 6.4 through 8.5 (except 8.2.4))

2. Repeat Nonconformity:

Nonconformities previously identified within the last 3 years are escalated due to the increased risk they pose, indicating insufficient corrective action.

3. Absence of a Procedure:

The absence of a documented process or procedure significantly impacts consistency and effective implementation, warranting escalated grading.

4. Release of a Nonconforming Medical Device:

Nonconformities leading to the release of a nonconforming medical device into the market directly signify a QMS failure, resulting in higher-risk grading.

These factors collectively contribute to the grading of nonconformities. Starting with the impact, indirect impact initiates at a grade of 1, while direct impact begins at 3. Subsequently, any true escalation factors (repeat nonconformity, absence of a procedure, or release of a nonconforming medical device) increase the finding grade. While a grade of 6 is theoretically attainable, the highest grade assigned remains a critical 5. This stringent grading system ensures thorough assessment and prompt reporting of critical findings to uphold the integrity and safety of medical devices.

In conclusion, the Medical Device Single Audit Program (MDSAP) stands as a transformative initiative, streamlining regulatory processes for medical device manufacturers worldwide. By enabling a unified approach to audits and assessments, MDSAP not only empowers manufacturers to meet the diverse requirements of participating countries but also fosters a culture of continuous improvement and excellence. Through standardized procedures, transparent expectations, and stringent grading, MDSAP ensures the highest standards of quality and safety in the production of medical devices. This collaborative effort between manufacturers and regulatory authorities marks a significant milestone in the global healthcare industry, ultimately benefiting patients and providers alike. As MDSAP continues to evolve, its impact on the industry is poised to be both profound and enduring.