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Regulatory Responsibilities of an OEM and Private Label manufacturer


What are the regulatory responsibilities of an OEM and a Private Label manufacturer?

We are a small manufacturer of components (not finished devices) and are looking into the prospect of manufacturing finished medical devices for a private labeller in Canada and US. We are transitioning to ISO13485:2016 & MDSAP.

I appreciate all your input :)
Hi natgster,

Where are you based? I will assume neither U.S. nor Canada.

For the U.S., the designation as an OEM or Private label manufacturer doesn't relieve you of any duties, and in fact adds complexity to creating maintaining your FDA database registrations (based primarily on the number of customers/brands you manufacture for). You are a manufacturer and a foreign establishment. So you have to comply with the regulations and appoint a U.S. Agent, whom you can, by contract, assign certain responsibilities above and beyond those required under the regulations. But the ultimate responsibility is yours.

Your customers, as probably Initial Importers have some overlapping and separate duties. And you can also, by contract, assign some duties to them. But again, you're putting the device into commerce in the U.S. so you're ultimately responsible, and jointly responsible in the eyes of the FDA under many scenarios.

For Canada, again, the ultimate responsibility lies with you but there is joint responsibility with your customers. You will also appoint a regulatory correspondent and can assign them a substantial scope of work. Our U.S. Agent also acts as our Canadian Regulatory correspondent.

This is quite general but I'm not sure the level of detail you are looking for. The regulations, if you're comfortable going through them, spell out the specific duties and responsibilities.


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If you are manufacturing a MD as defined in the FDA and is being imported into USA, you need to :
1. Register your establishment with FDA and renew annually as long as you are manufacturing.
2. Have an USA agent for FDA
3. List the MD that you are making with reference to the 510k of principle, in the capacity of contract manufacturer and have on record the device listing number that gets generated after the device listing in the FDA site. Perhaps your private labeller in the USA has also done the device listing with reference to the principle in USA, in a different capacity.
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