Do you need an Initial Importer ?
Are you a foreign manufacturer of medical devices ?If the answer is yes, you need to pay attention at the FDA regulations about exportation to the US market. If you don’t have a physical presence in the US and if that establishment in the US is not registered with the FDA, you need to make sure your buyer in the US is registered as Initial Importer to the FDA.
The best option is to work with a third party who could be your Initial Importer umbrella for the entire US market.
But don’t worry, we can help !
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment (Title 21 CFR Part 807).
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.
- 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).