Determining if MDSAP Is the Right Regulatory Course—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

For many companies, selling a product into one country’s market is challenging enough. There are specific regulations with which they must comply and be able to stand up to the country’s regulatory agency audit. Companies like these can hardly imagine meeting the requirements of multiple agencies in multiple nations to sell products more broadly.

Fortunately, a regulatory avenue provides a pathway to do just that. The Medical Device Single Audit Program (MDSAP) offers a way for companies to meet the regulations of multiple nations while doing so via a single inspection conducted by a recognized auditing organization. The program opens the door to market into certain countries that participate or recognize in it. Of course, regulatory review of the product is still required.

To further explain the details of MDSAP, why it may be attractive to medical device OEMs, and how contract manufacturers can benefit, Dawn Tibodeau, Global Regulatory Affairs Principal – MDSAP at TÜV SÜD America Inc., participated in the following Q&A. She responds to several questions on these topics while also offering more insights on the specifics of the program.

Sean Fenske: What is MDSAP and why is it relevant to medical device manufacturers?

Dawn Tibodeau: MDSAP is a single audit based on ISO 13485 and country-specific regulations, which is conducted by authorized or recognized auditing organizations and satisfies the requirements of the official participating regulatory jurisdictions—Australia, Brazil, Canada, Japan, and the U.S.

Fenske: Why should a company consider the MDSAP program? What benefits does it offer?

Tibodeau: The purpose of the program is to provide audits that are less burdensome for manufacturers while still effectively providing regulatory oversight. Auditing organizations can cover the requirements of multiple jurisdictions in a single audit, thereby reducing the need, in many cases, for the regulatory authorities to individually conduct onsite audits.

Fenske: How should a company prepare for an MDSAP audit? What factors should be considered?

Tibodeau: Since MDSAP is a regulatory audit, manufacturers must be familiar with the applicable regulations in the jurisdictions they wish to enter and have incorporated the requirements into their quality system prior to the MDSAP audit, even if they have not started selling their devices into the participating countries.

Fenske: How does MDSAP help facilitate a global market access strategy?

Tibodeau: MDSAP is not only utilized by the five official regulatory authorities. There are also currently eight affiliate members that make use of the program by accepting MDSAP audit reports and/or certificates submitted by the manufacturer as part of its medical device regulatory pathway. By participating in MDSAP, manufacturers may gain additional regulatory pathways beyond traditional approaches, helping streamline regulatory activities and potentially facilitating access to multiple global markets.

Fenske: What is the MDSAP Medical Device Organization (MDO) Pilot Program? Why should companies explore this opportunity, and what does expanded eligibility mean for MDOs?

Tibodeau: The MDO Pilot Program has been in place since August 1, 2026, and will run through April 2027. Prior to the MDO pilot, only “legal” manufacturers or those that market a medical device under their own name were able to gain MDSAP certification. Now, however, with the pilot in place, contract manufacturers and specification developers are also allowed to participate and hold their own MDSAP certificate, which covers the regulatory requirements for Brazil, Japan, and the U.S. This not only allows contract manufacturers and specification developers to gain the same benefits of the program as the “legal” manufacturers, but it may also be seen as an added benefit by organizations that wish to contract with them.

Fenske: What is TÜV SÜD’s relationship with MDSAP? What is the organization’s role in the program?

Tibodeau: TÜV SÜD is a recognized auditing organization under the MDSAP program, and we have been participating since the original pilot. We have auditors around the globe who are not only able to conduct MDSAP audits, but also able to combine them with other regulatory audits such as EU MDR/IVDR and, or accredited ISO 13485 or ISO 9001 audits.

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