What Are The FDA Agent Requirements For Bringing Your Medical Device To The US Market

What Are The FDA Agent Requirements For Bringing Your Medical Device To The US Market?

If you are a commercial entity, located outside the US, engaged in the business of manufacturing and supply of medical devices and wish to sell your products in the US, then there are two important guidelines that you need to follow: 1. Appoint a US agent for your establishment 2. Register your establishment with the US FDA before you export devices from your country to the US. Interpreting the guidelines of the FDA for US Agent representation for bringing your medical device to the US market can be a tough nut to crack for a novice, read on to know more about these requirements and what steps you need to take.

When are these guidelines applicable?

These regulations are applicable to your company if you fall under any of the below-mentioned categories: -

Custom device manufacturers Manufacturers of components Contract manufacturers and sterilizers Establishments that maintain complaint files Re-processors Foreign exporters Re-labellers/re-packagers, Foreign manufacturers (including kit assemblers) Remanufacturers, and Specification developers

What are the steps that you should take before, during, and after the registration process is initiated?

In order to comply with the FDA requirements, there are certain steps that you need to take before you can bring your medical devices to the US for commercial purposes. Here are the steps that you must take: -

Your company must appoint a US Agent to act as a liaison between the FDA and your company.

The agent whom you appoint must be residing in the US and should be available to offer assistance to FDA during regular working hours.

The US Agent will communicate with FDA on a range of matters such as assistance ​with scheduling FDA inspections of foreign establishments,

-

-

-

general questions about an establishment’s activities, and responding to questions concerning devices registered for import.

The US Agent must make undertake all steps necessary for FDA establishment registration which include listing all devices that are to be imported, updating registration, and listing information on a regular basis, and annual renewals.

The US Agent must ensure that the initial listing and registration must be made in the online database of the FDA before the import procedure for the devices is initiated. But the same must be made only after getting the PMA approvals, and 510(k) clearances.

You need to remember that all the medical devices to be imported, irrespective of their class, must be listed.

The guidelines specified by the FDA can be difficult for any novice to handle but is nothing that a seasoned US Agent can not handle. So, in order to keep your attention focussed on the commercial aspects of your business, you must enlist the assistance of a US Agent to comply with the ​FDA agent requirements​.