Medical Device Registration and Listing Help

[radar1402]

Dear Covers,

Hoping someone may be able to help with this issue:

We are a specification developer based in the UK, our products are manufactured by a contract manufacturer in S. Korea, we do not physically handle product that is exported to the US. We have an establishment registration and device listing for our US devices.

We also have a US sales office which acts as our initial importer but does not physically handle product. The US office has an establishment registration as a complaint file holder and has listed our US devices.

Our contract manufacturer also has an establishment registration as a contract manufacturer and has listed our devices that they manufacturer. All our devices will be exported from S. Korea directly to the US.

So far so good, until I try and set up the US office as the initial importer, when I try to identify the contract manufacturer as the manufacturer for the device I get an error message that the contract manufacturer is not a manufacturer. I don't want to put the UK specification developer down as the manufacturer as the devices will not be shipped from the UK and I don't want the devices held in customs.

Any ideas where I've gone wrong, and how to fix it?

Thanks

 

[MIREGMGR]

You have to state the Specification Developer, i.e. party with regulatory Manufacturing responsibility, as the Manufacturer.

FDA PREDICT understands the difference between the Responsible Manufacturer and the physical manufacturing site. Just make sure that your freight forwarder or other import handling party is entering the information that PREDICT is actually asking for, and PREDICT will match it up with your listing info and release the shipment.

The point is not to avoid informing PREDICT of complex information...it's to make sure that the information in your listing matches the information you tell to PREDICT. If everything matches up, irrespective of complexity, you're good.

 

[baseball2k2k]

Dear Covers,

Hoping someone may be able to help with this issue:

We are a specification developer based in the UK, our products are manufactured by a contract manufacturer in S. Korea, we do not physically handle product that is exported to the US. We have an establishment registration and device listing for our US devices.

We also have a US sales office which acts as our initial importer but does not physically handle product. The US office has an establishment registration as a complaint file holder and has listed our US devices.

Our contract manufacturer also has an establishment registration as a contract manufacturer and has listed our devices that they manufacturer. All our devices will be exported from S. Korea directly to the US.

So far so good, until I try and set up the US office as the initial importer, when I try to identify the contract manufacturer as the manufacturer for the device I get an error message that the contract manufacturer is not a manufacturer. I don't want to put the UK specification developer down as the manufacturer as the devices will not be shipped from the UK and I don't want the devices held in customs.

Any ideas where I've gone wrong, and how to fix it?

Thanks

Does being an initial import allow you any access to LST #s?

 

[QA-Man]

No. A company can only access there own listing numbers. You can see most of the other information on the public establishment listing.