US manufacturer of export only devices

[craiglab]

Does a US company (startup) that plans to have 100% mfg in Asia and sell 100% in the EU register their establishment as a ?U. S. manufacturer of export only devices.?
Naturally, some units would need to be imported to the US before distribution for validation/studies and it?s likely that units will need to be sent to the US later on for complaint investigations or possibly repair.
FDA DICE came back with just general information.
Thanks!

 

[Jen Kirley]

A quick bump...

Can anyone help?

 

[MIREGMGR]

You could. Seems though that you'd have more operational flexibility, and possibly avoid future friction with Customs and/or FDA PREDICT, if you just registered as a Manufacturer.

 

[craiglab]

A very late thank you for replying.

Maybe a more general question, but when selling a device "made in China" to another country, without it ever being imported to the US, is that exporting?

US Mfr of Export Only Devices comes from 807(a)(2) "Sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person."

The company with their name on the device is the manufacturer - they initiate the specifications. The contract manufacturer in China is also the manufacturer.

So I'm confused on the definition of "export", which one might think means from inside to outside the U.S. unless having the device manufactured in China makes no difference.

I hope this makes sense.

 

[Ronen E]

I would have registered as a Specification Developer.

 

[craiglab]

Possibly they could register as a specification developer. But they have contracted with local designers that have provided them with prototypes and documentation, the CM in China is basically waiting for design transfer, there is a CM in another country that will build a disposable piece that is packaged and shipped to the distributors separately, they contracted with a manufacturing expert to design custom dispensing and welding machines at that overseas facility... their QA person will approve all shipments from the CM to EU importer...

Doesn't this sound more like a manufacturer that has outsourced production activities? They have followed design controls and have quality agreements with the CMs.

 

[Ronen E]

But they have contracted with local designers that have provided them with prototypes and documentation, the CM in China is basically waiting for design transfer, there is a CM in another country that will build a disposable piece that is packaged and shipped to the distributors separately, they contracted with a manufacturing expert to design custom dispensing and welding machines at that overseas facility... their QA person will approve all shipments from the CM to EU importer...

All this is irrelevant to them being or not being a Specification Developer.

Doesn't this sound more like a manufacturer that has outsourced production activities? They have followed design controls and have quality agreements with the CMs.

A Specification Developer IS a manufacturer who has outsourced all production activities.

 

[craiglab]

Thanks Ronen. I've read some of your other posts on this and it makes sense now. I'll need to research how the Spec Developer complies with 13485 and CFR.

Regarding FDA, the company could register as a Spec Developer and export under 801(e)(1). Is it "exporting" even when the product goes directly from China to the EU? I've been looking for that definition...

 

[Ronen E]

I'll need to research how the Spec Developer complies with 13485 and CFR.

ISO 13485: Any clauses covering only activities that are irrelevant to the spec developer's operations (e.g. N/A or completely outsourced) should be excluded from the scope, with a justification documented in the quality manual.

21 CFR 820: Specific guidance for spec developers was provided by FDA:

Contract manufacturers and specification developers shall comply with the sections of the QS regulation that apply to the functions they perform.

(...)

Specification developers are manufacturers and are subject to the GMP requirements that apply to the activities they conduct, such as various design controls including correct transfer of the design information to a contract manufacturer [820.30(h)]. This activity, in turn, requires an adequate device master record (820.181) and adequate change control [820.40(b)]. Further, if the product carries the specification developer's label, the developer is responsible for maintaining a complaint file and processing complaints, plus maintaining the device specifications and other appropriate documents in the device master record.

Regarding FDA, the company could register as a Spec Developer and export under 801(e)(1). Is it "exporting" even when the product goes directly from China to the EU?

I don't think that the described setup has anything to do with export. The registration as a spec developer is essentially for streamlining any possible encounter with FDA (I doubt they will take much interest unless the subject devices are involved in a major catastrophe in Europe), and any instances where subject devices, otherwise suitable for commercial distribution, need to enter the USA for non-commercial distribution purposes (as you've described, etc.).

Cheers,
Ronen.