What should you do before importing condoms ?

As condoms belong to Class II medical devices, you should get the approval from your local Ministry of Health Department before you import condoms.

For a shipment of condoms or any Class II medical devices are imported into the US, Customs and Border Protection (CBP) and the FDA will want to see that

1. A 510(k) Premarket Notification for the devices has been approved by FDA,

2. The importer of record has filed a Device Initial Importer Registration with FDA, and

3. The foreign manufacturer has filed a Device Facility Establishment Registration with FDA.

4. An electronic copy (eCopy) of the Premarket Submission (that is the 510(k) and Premarket Approval applications) must have been validated by FDA’s eCopy loading system, and

5. The ecopy must be accompanied by a hardcopy of the Premarket Submission documents along with a signed cover letter that states “This eCopy is an exact duplicate of the paper copy.”

If you plan to import condom, we can supply and produce condom as per your requests. Email: linda@oemcondoms.com