As per FDA regulation, manufacturers, initial exporters, and importers must complete medical device FDA Registration. It is the official process of registering your establishment with the agency. This applies to various types of establishments, including:
- Drug manufacturers
- Medical device manufacturers
- Food processors and packers
- Cosmetics manufacturers
- Tobacco product manufacturers
By registering, you provide the FDA with essential information about your facility, operations, and products. This allows them to monitor your compliance with safety and quality standards and take appropriate action if necessary.
Registering with the FDA offers several benefits for your business:
- Compliance: It ensures you meet legal requirements for operating in the U.S. market.
- Credibility: It demonstrates your commitment to safety and quality, boosting consumer confidence.
- Market Access: It’s often a prerequisite for selling your products in the U.S.
- Reduced Risk: It helps prevent potential regulatory action or product recalls.
The process of medical Device FDA certificate registration is as follows:
- Check the device Product code and Regulation number
- Check for 510k exemption
- Appoint US FDA Agent (Only for Foreign Manufactures)
- Fill and submit the Establishment Registration application form with US Agent appointment Authorization
- Facility Name/address information
- Device Class and code
- Make a US Agent annual payment.
- Create an Account with FDA
- Make a payment at the Device Facility User Fee (DFUF) website and get a
- Payment Identification Number (PIN)
- Update Registration and Listing System (FURLS) account for the owner or the operator.
- Verify registration and Listing information on the FDA website
Center for Devices and Radiological Health (CDRH) released PCD, which contains the device name and product code. The name and product code assigned to a particular device is based on the risk class detailed in 21 CFR Parts 862 – 892.
refer to below FDA Links for
- Search the online product code database
- Information on how to classify a device
- Download Product Code files
All foreign manufactures must appoint US Agent for FDA certificate registration. The U.S. agent must either reside in the U.S. with a place of business in the U.S. and must be available to answer any phone during normal business hours.
The following are the major responsibilities of the U.S. agent:
- Assisting FDA in communications with the foreign establishment,
- Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States,
- Assisting FDA in scheduling inspections of the foreign establishment and
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
- 510k Submission ( additional offerings)
To inform the U.S. agent has no responsibility related to reporting adverse events under the Medical Device Reporting.
- Guidance, DUNS validation, FDA Device Code Identification: $449 onwards
- US Agent Service: $449 ( Only for Foreign Manufactures)
- Device Listing: Free up to 2 devices. Additional devices $150.
Medical Device FDA Registration and Listing assured completion in 4 working days.
All existing medical devices and IVD establishments engaged in manufacturing, exporting, and Importing must renew registration at the start of every financial year to keep registration active. Refer above to know the fees.
Furthermore, you might be already registered but need to change the US Agent or complete a fresh FDA Registration or FDA 510k submission, or need FDA Inspection support. We are there to help. Write to us for more information.
