The new year has begun, and your 2017 FDA Establishment Registration has been renewed.

Every foreign manufacturer selling Medical Devices in the USA, after obtaining product registration, must register his plant (Establishment Registration), complete Device Listing for all devices sold in the USA, and conform with American GMP. The Establishment Registration and Device Listing oblige the manufacturer to designate a US Agent and specify an Initial Importer for his products.

The Initial Importer, in particular, must have offices in the USA, and is responsible for customs clearance; he is thus responsible for transferring the devices from the foreign manufacturer to the agent charged with distributing and selling the products in the USA. The Initial Importer does not modify the products he imports in any way.

But is the Initial Importer exempt from the specific requisites of USA regulations regarding Medical Devices? Of course not! It is therefore essential that the manufacturer choose an Initial Importer who is conforming with the requirements of 21 CFR.

In short, the Initial Importer must:

  • satisfy Medical Device Reporting requirements (21 CFR 803.40 and 21 CFR 803.42): report all incidents and adverse events resulting in death or serious injury to the patient, as well as any malfunctions of the devices he imports, to the FDA;
  • register, report and archive all non-conformities, customer complaints, recalls and all post-market survey activities;
  • conform with specific procedures envisaged in 21 CFR 820 regarding the storage, keeping and handling of the devices he imports;
  • ensure the tracking of the devices he imports (21 CFR 821).

It is therefore essential that you do not confuse the figure of the US Agent, who has a purely administrative role, with that of the Initial Importer who, on the contrary, has specific regulatory responsibilities in the distribution of your Medical Devices.

This is why the Initial Importer is also required to register his premises with the FDA, and is therefore subject to inspection by the FDA itself.

Let us not forget that the FDA sees the Initial Importer as the representative of the manufacturer in the USA, and that the manufacturer is thus responsible for choosing an Initial Importer who is conforming with regulatory requirements.

So, how do you do this? How can you be sure that your Initial Importer is conforming and will not land you in trouble with the FDA? In two steps:

  • by drawing up a specific agreement setting out the quality and regulatory obligations of both parties as required by USA regulations, the Quality Technical Agreement (QTA);
  • once the rules have been established in the QTA, by running periodic verifications (questionnaires, simulations, audits) to ensure that the Importer is fulfilling his obligations.

So… are you confident about your Initial Importer?


Do you want more information about the USA? Go to our U.S.A. country section!

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Silvia Scarpellini

RA Manager