Neither the FDA nor the EU MDR officially/formally use the term "marketing authorization holder" (MAH). Thus, it is best not to use the MAH terminology regarding those jurisdictions.
Instead, for the EU MDR, there are, for example, "manufacturers", "distributors", and "importers". Each has its own unique definition and needs to be applied properly for a given scenario.
The EU MDR's definition of "manufacturer" is not simply contingent on sale and distribution. Instead, it in addition means the party selling and distributing under its own name (on the label). In other words, an EU MDR "distributor" may be selling and distributing, yet is not the "manufacturer" if the distributor is not selling and distributing the subject device under the distributor's own name.
As a critical aside regarding the language "sell and distribute", remember that such language is not the EU MDR regulatory trigger. Instead, the EU MDR regulatory trigger is "placing on the market" rather than "sale and distribution". Accordingly, be sure that you are assessing your business configurations in proper application of the EU MDR regulatory term "placing on the market" rather than "sale and distribution".
For the FDA jurisdiction, some key regulatory roles are "manufacturer", "contract manufacturer", "specification developer", "initial importer", "wholesale distributor", "private label distributor", "complaint file establishment", and "foreign exporter", to name a few.
Most often (but not always), the 510(k) owner/holder is regulated by FDA as the "manufacturer" or "specification developer", including but not limited to the corresponding establishment registration obligations. FDA will reflexively do this unless it is properly informed otherwise. For example, I'm helping a client right now whose business model involves multiple establishments that weren't properly categorized prior to my firm's involvement. In that case, FDA is viewing an initial importer to instead be the specification developer, and also has much confusion about associated role of an associated foreign fabricator/assembler. Significant FDA enforcement gestures have been made, and the issue is becoming very costly to the stakeholders' budgets and brands. This is an example of how messy and costly it can be when the various parties aren't properly categorized with FDA from time zero.
Wholesale distributors are exempt from FDA establishment registration unless they are a foreign exporter or the initial importer. That categorization is often appropriate for down-stream distributors after the initial importer.
You may find it helpful to hire an expert who can definitively assess your particular business arrangements so as to be sure they are properly categorized with respect to the EU MDR and FDA's unique regulatory terms.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Oct-2023 10:35
From: Anonymous Member
Subject: Who would be the marketing authorization holder?
This message was posted by a user wishing to remain anonymous
Hello,
I work for an office that distributes and sells medical devices from foreign manufacturer. As we are not the first importer, our office is not registered. Rather we provide some helps to the foreign manufacturers when they prepare 510Ks. (the manufacturer is the 510K owner). Recently, we got a question about who would be the marketing authorization holder (MAH) for their medical devices, to clarify who pays for establishment fees etc. When I looked up, MAH is defined as the ones who sell and distribute the medical devices in Europe. But under the FDA website, the definition can't be found and it's somewhat vague. I always thought that the 510K owner is the MAH, thus the manufacturer should pay for the registration fees. Would appreciate your thoughts.