The term MDSAP stands for the Medical Device Single Audit Program, an international initiative focused on the oversight of medical device manufacturing. This program was established to create a unified approach to auditing a manufacturer’s quality management system against the requirements of multiple countries simultaneously. MDSAP provides a mechanism for a single, third-party audit to satisfy the regulatory expectations of several major global markets, streamlining the compliance process for companies that produce medical devices for worldwide distribution.
Defining the Medical Device Single Audit Program
Before the MDSAP, manufacturers seeking international sales faced separate, redundant audits for each country. This fragmented approach consumed significant time and resources, leading to inefficiencies and business disruptions. The International Medical Device Regulators Forum (IMDRF) developed the MDSAP to address this challenge by introducing a shared regulatory framework.
The foundational concept of the program is built around the internationally recognized standard for quality management systems, ISO 13485. The MDSAP audit model integrates the general requirements of ISO 13485 with the specific national regulatory requirements of the participating jurisdictions. This means a single audit scope covers both the global quality system standard and the unique Good Manufacturing Practice (GMP) requirements of the member countries.
Standardization allows a single audit report to be accepted by all participating regulatory authorities. This reduces the overall audit burden on manufacturers while maintaining the rigor of regulatory oversight. The program aims to improve the consistency and predictability of audit outcomes across the medical device industry worldwide.
Participating Regulatory Authorities
The MDSAP involves five governmental bodies, known as Regulatory Authorities (RAs), that jointly oversee the program and accept its audit results. These RAs are the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), and the U.S. Food and Drug Administration (FDA).
The manner in which each authority utilizes the MDSAP audit report varies based on their national regulations. For instance, Health Canada has fully transitioned to this program, requiring MDSAP certification for most classes of medical device licenses in their country. This makes participation mandatory for manufacturers who want to sell medium to high-risk devices in the Canadian market.
In contrast, the U.S. FDA accepts the MDSAP audit report as a substitute for its own routine inspections of medical device manufacturers. The FDA utilizes the report in its regulatory decision-making process, though it retains the authority to conduct independent inspections when necessary, such as for “for cause” investigations. Brazil’s ANVISA also accepts the MDSAP audit results for regulatory purposes, including the granting and maintenance of its Good Manufacturing Practice certificates.
Navigating the MDSAP Audit Process
The MDSAP audit is conducted by an independent, authorized Auditing Organization (AO). These AOs must meet strict competency requirements and follow a standardized audit model to ensure consistency across all global assessments. The audit process itself is structured around a defined three-year cycle.
The process begins with an initial certification audit, which is typically broken down into two or three stages to ensure the manufacturer’s quality management system is fully documented and implemented. Following certification, manufacturers undergo annual surveillance audits, which assess continued compliance with the requirements. After the third year, a re-certification audit is conducted to renew the manufacturer’s MDSAP status for the next three-year cycle.
A unique feature of the MDSAP is its nonconformity grading system, which replaces the traditional “major” or “minor” classifications with a standardized point scale ranging from 1 to 5. This system uses a grading matrix and specific escalation rules to determine the severity of any identified nonconformity. Points are assigned based on the impact on the quality management system—whether direct or indirect—and the frequency of recurrence.
For example, a nonconformity is escalated by one point if there is an absence of a required documented procedure or if a nonconforming device was released to the market. A grade of 4 or 5 is considered a high-risk finding, triggering a requirement for the manufacturer to submit a corrective action plan to the Auditing Organization promptly. The AO then compiles a detailed MDSAP Audit Report, which is made available to all participating regulatory authorities for their review and use in regulatory decision-making.
Impact on Global Medical Device Compliance
The Medical Device Single Audit Program represents a significant step toward achieving global regulatory reliance in the medical device sector. By accepting a single audit report, participating countries reduce the need for their own regulatory bodies to conduct separate, on-site inspections. This pooling of resources allows regulatory authorities to focus their efforts on higher-risk compliance issues and emerging technologies.
For medical device manufacturers, the program simplifies the complex process of gaining market access in multiple countries. A single, successfully completed MDSAP audit acts as a powerful signal of compliance, accelerating the time it takes to bring devices to patients in those five markets. This streamlined approach minimizes operational disruption and saves substantial costs associated with hosting numerous individual country audits.
This international cooperation benefits patients and healthcare systems by promoting a high level of quality control. The standardized audit methodology ensures that manufacturers adhere to rigorous quality standards, which contributes to the global safety and effectiveness of medical devices. This alignment fosters a more efficient and predictable regulatory environment for a globalized industry.