Understanding The Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP), initiated by the International Medical Device Regulators Forum (IMDRF), created a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices.

This global approach included the development of an international coalition of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices. The MDSAP provides for medical device manufacturers to use one third-party audit to confirm for compliance with the regulatory requirements of five medical device markets, including Australia, Brazil, Canada, Japan, and the United States.

In Australia, the Therapeutics Goods Administration (TGA) will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

In Brazil, the Brazilian National Health Surveillance Agency (ANVISA) will use the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre- and post-market assessment procedures, providing, when applicable, key information that is expected to support regulatory technical evaluation on these issues.

In Canada, Health Canada will use an MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Health Canada's intent is to implement the MDSAP as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both pre- and periodical post-market audits under applicable regulations.

In the United States, the FDA’s Center for Devices and Radiological Health (CDRH) will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, this MDSAP program will not apply to any necessary pre- or post-approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the 21 U.S.C. 360c(f)(5) concerning the classification of a device.

The Purpose of MDSAP

The MDSAP was developed to:

• Operate a single audit program that provides confidence in program outcomes
• Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems, while minimizing regulatory burden on the industry
• Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators, while respecting the sovereignty of each authority
• Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices
• Promote consistency, predictability, and transparency of regulatory programs by standardizing the practices and procedures of participating regulators for the oversight of third-party auditing organizations and the practices and procedures of participating third-party auditing organizations, while leveraging, where appropriate, existing requirements and procedures for conformity assessment

The Benefits of MDSAP

MDSAP offers many benefits to medical device manufacturers, including the following:

• A single, third-party audit is used in lieu of multiple separate audits or inspections by participating regulatory authorities or their representatives. Therefore, for many medical device manufacturers, the MDSAP reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.
• It is expected that the program will enhance confidence in the reliability of third-party audits, that more regulatory authorities will join the program, and that other regulatory authorities will use information made available through the program to limit the need for additional audits.
• Some participating regulatory authorities will use MDSAP audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.
• Like in any third-party auditing program, the medical device manufacturer is free to choose among all authorized auditing organizations to perform the audits. Routine audits are announced and planned with the manufacturer.
• The MDSAP is expected to improve the predictability of audit outcomes through enhanced auditing organization recognition criteria, monitoring of auditing organizations by the participating Regulatory Authorities, the use of a standard MDSAP audit model, the grading of any nonconformity using objective criteria to characterize the significance of the finding, and the reporting of the audit outcomes using a standard report template.
• Enrolling in the MDSAP may be seen as evidence of a medical device manufacturer’s commitment to quality management systems for product quality and regulatory compliance.

ProPharma Group and Audit Preparation

We encourage our medical device manufacturing clients to take advantage of the MDSAP whenever possible. With our help, our clients enter into their audits fully prepared. That’s because they are leveraging our more than 35 years of pharmaceutical and medical device industry experience. Contact us today to learn more about how we help our clients obtain and maintain compliance by conducting independent audits.