How to Get FDA Registration for Your Medical Devices?

Businesses engaged with the manufacturing, relabeling, repacking or export of the medical devices to the U.S. are required by FDA law to register with FDA and comply with FDA regulations. A foreign company working at offshore location or outside the US must appoint an FDA US agent who will help in the FDA device registration process and compliance with FDA rules.  

Selecting an experienced company or an independent US agent who is well-versed with FDA regulations and requirements can help you get registered or renew your device registration in a timely manner. This will ensure that your business gets registered with FDA and you can smoothly carry out the business transactions and promotion without any legal complication posed by US FDA.

If you are the manager of a company engaged in manufacturing and distribution of medical devices for commercial purposes in the US, you would require FDA Device Registration annually. You would require registering and mentioning the types of devices and their functionalities or ways in which they are used at that establishment to get proper FDA registration. 

Here is a checklist of ways through which you can get registered in a proper way.

• Pay fee for annual registration

As per the Food and Drug Administration Amendments Act (FDAAA) of 2007 every company engaged in the manufacturing, relabeling, repacking or export of the medical devices sold in the U.S. are required to pay a registration fee and provide listing information electronically unless a waiver granted by the FDA. For the payment, they can pay via FDA online platform and obtain a Payment Confirmation Number (PCN). Once the payment has been made, as this process may take one week or more, one needs to make payment in advance for timely registration.

• Submit your registration and listing information online

After a PCN has been received, the owner/operator of the medical device establishment needs to use FDA online platform to complete the FDA device registration process and list their devices on FDA. For this, they need to create an online account ID and password. Hiring an FDA US agent requires that a sub-account for the official correspondent should be created with a separate account ID and password for the same. Renewal of registration requires that the owner uses the same User ID and password that has been created earlier at the time of registration.

• Get e-mail confirmation from FDA that you have met all requirements.

Once you pay the annual fee and submit your business listing info and registration electronically you will get the confirmation through mail that all requirements for FDA registration have been met.  This will help you complete the registration process and thus gain peace of mind.