FAQ

A foreign manufacturer who has FDA Establishment Registration with a listed device must have a FDA-registered Initial Importer. MDPPS can contract with anyone in the supply chain but MDPPS must have the contact info with the manufacturer to reference the device listing number.

Manufacturers, Contract Manufacturers, Contract Sterilizers and Foreign Exporters are among the most common companies that need FDA Establishment Registration and pay the fee (was $9,280 in 2024) ; most domestic distributors do not need Establishment Registration. See https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee for the complete list.

Domestic Distributors and others do not need Establishment Registration with FDA.

Large carriers like UPS, FedEx and DHL may have FDA specialists you can appeal to. If you use ocean or truck or a small carrier they may need coaching on FDA entries. MDPPS can work with your Carrier to provide the information for customs and/or FDA.

To avoid delays and holds, the best action you can do as a sender or receiver is to make sure the commercial invoice has all the information required for Customs and FDA before the medical device is sent. Contact your carrier or Customs broker and request the commercial invoice and other required document be “electronically attached” to the shipment. MDPPS provides support to help you with both of these actions, as part of our Initial Importer services.

Contact your Carrier or Customs Broker and request the Commercial Invoice, Entry Summary, FDA Notice of Action and any other documents they have for the shipment and contact MDPPS. If you are an MDPPS Client we can work to resolve the issue(s) holding up the shipment. Most shipments are held due to missing, incomplete or incorrect Information. MDPPS can help provide the needed Information for the shipment, and help you establish your process to provide the needed information in future shipments.

The most common reason is missing, incomplete or incorrect information regarding who to contact. US Customs or FDA will in general only contact either the specified Shipper, Customs Broker, or FDA Registered Initial Importer. MDPPS will help you clearly identify the various parties on the shipping documents so if there is an issue, the proper party(ies) will be contacted. Often the invoice is not clear on who to contact; review a draft of the invoice with the sender before sending. Carriers often submit entry data to customs before the shipment arrives; check with your broker or carrier. Sometimes carriers are delayed. On rare occasions the inspector has a question and waits for answers. Sometimes carriers have a last minute shipping charge they want money for.

US Customs and FDA have provisions for importing single Medical Device to the US for Personal Use as a Non-Food Product -- for personal use as a medical device. MDPPS can help you prepare the shipping documents for this situation.

MDPPS has the expertise on what’s needed by FDA when shipping Medical Devices to the US. We can work with your Customs Broker or provide you with the information needed by FDA.

The most common reason is missing, incomplete or incorrect information. If you are an MDPPS Client, we can work with you and your Customs Broker (if applicable) will determine and provide the needed information. Then we work to resolve the issue(s) holding up the shipment. MDPPS can help you establish your process to provide the needed information in future shipments.

Because it was found to be habit forming.

Domestic Distributors or US branch offices of a foreign company who do not otherwise modify devices can use an Initial Importer like MDPPS to avoid Establishment Registration fees.

These entities must list their Medical Devices: Manufacturers, Contract Manufacturers, Specification Developers and Sterilizers. The Initial Importer and the commercial invoice needs the Listing Number from the manufacturer.

1. Using MDPPS as your Initial Importers will provide the Initial Importer service for a fraction of the cost of setting up your US office as an FDA Registered Initial Importer.
2. Having MDPPS as your Initial Importer will also save on costs of having shipments delayed or held due to the inadequate shipping documents.

FDA may take 2 months or more after receiving the Establishment Registration fee to assign the Establishment number. The sender in the meantime should take a screenshot of the Action Establishment Registration and provide a copy with the shipping documents. Also, record on the Commercial Invoice “Establishment Status is Active , awaiting assignment of registration number”.