Certificate of Exportability - Contract manufacturer located outside the US

[IreneS]

Hi, my company encountered a problem regarding COE (Certificate of Exportability). I'll appreciate any discussion from any. Here's our situation.

We are a contract manufacturer (lets call us as BBB), who is located outside of the USA, for a legal manufacturer in USA (lets say it is AAA). This product is a Class III medical device. AAA is not going to seek for FDA clearance for the product. Thus, it is an unapproved product.

We (BBB) now would like to import the device into our country. The regulatory in our country required us to provide COE from FDA to prove the product is manufactured by a US company (AAA). However, as we asked AAA to apply for COE, they told us that FDA couldn't issue them COE since we (BBB) take care of the major parts of manufacturing process. FDA needs to do an on-site inspection on us to ensure we (BBB) comply with the current good manufacturing practice requirements.

My question is, if this is true that an unapproved class III product manufactured by a contract manufacturer can't acquire COE before the contract manufacturer being on-site inspected? It seems making no sense for me. We could wait forever before FDA may have a little...little chance to do the on-site inspection on us.

 

[Ajit Basrur]

Welcome to the Cove, Irene

Sorry, I do not have answer to your question but did you check the below link?

Exporting Unapproved Devices

 

[IreneS]

Hi Ajit,

Thank you so much for the reply.

Yes, we have read the article. It is said that the manufacture must comply with the good manufacturing practice requirement. The problem is, as AAA tried to obtain the COE, FDA told them that FDA has to do an on-site inspection for BBB since BBB is a major contract manufacturer.

I wonder how come an unapproved medical device has to be strictly reviewed like this. As now, we won't be able to get COE if FDA can't inspect on us which seems most like will happen in a long long future. I am so confused about it...

 

[Sarah Stec]

I wonder how come an unapproved medical device has to be strictly reviewed like this.

FDA has some statutory requirements that they need to abide by themselves. Unapproved devices that are being exported or that aren't even destined for the US aren't really reviewed by FDA, but the US parties involved have a few requirements on their end that FDA needs to check on. What country will the devices be exported to? Is AAA asking for a COE according to section 801 or 802 of the FD&C? Is AAA registered as a manufacturer for export-only devices?

Are you sure that you need a COE when it sounds like the devices will never physically be exported (they are manufactured in the same country in which they are to be sold, right? Did I miss something? I realize that the legal manufacturer is not located in the country in which they are to be sold.)?

 

[SylvieS]

In addition to Sarah's question I would also ask - why do you need the COE for ?
Some countries uses it to sustain the regulatory clearance process and have it fast tracked. However in your case, the device was not cleared in the US... and you would not be able to support your local application on any FDA clearance.