What is MDSAP (Medical Device Single Audit Program)?

In this article, you will learn what is MDSAP (Medical Device Single Audit Program).

Typically, the medical device industry receives and handles many external audits during the year from different regulatory agencies of each country in which their products are sold.  Sometimes they can receive more than one audit at the same time creating a difficult situation.

As you can imagine, it requires a lot of time and effort of its personnel, resources, and operational capacity.

In fact, they are willing to maintain the audit activities organized, controlled, and well monitored to comply with all regulatory aspects and expected requirements all the time.

Therefore, many medical device manufacturers are looking to be involved in this new innovative program to reduce the number of audits during the year.

So, What is MDSAP (Medical Device Single Audit Program)?

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions and countries.

Inspections are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five (5) different medical device markets (countries):

1. Australia,
2. Brazil,
3. Canada,
4. Japan,
5. The United States.

The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

WHICH REGULATORY AUTHORITIES ARE PART OF THE MDSAP AND WHAT IS THE PLAN FOR EXPANSION OF THE PROGRAM?

The MDSAP (Medical Device Single Audit Program) was developed by the following representatives:

• Australian Therapeutic Goods Administration (TGA),
• Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA),
• Health Canada, MHLW/PMDA,
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• S. Food and Drug Administration (FDA).

All regulatory authorities participating in the MDSAP are equal partners in the program.

Other Regulatory Authorities may eventually decide to participate in the MDSAP and to become active participants in the Program.

WHAT ARE THE BENEFITS AND POTENTIAL BENEFITS OF A MANUFACTURER PARTICIPATING IN THE MDSAP?

A single audit is used in lieu of multiple separate audits or inspections by participating in 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.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

For more information about what is MDSAP (Medical Device Single Audit Program), refer to:

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap