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FDA Medical Device Registration and Listing

For USFDA Class I exempted and Class I, II & III 510k cleared FDA Medical Device Registration.

The following type of establishments can register, list and market the medical device in United States of America:

  1. Contract Manufacturer
  2. Contract Sterilizer
  3. Foreign Exporter
  4. Initial Distributor
  5. Manufacturer
  6. Repackage
  7. Relabelers
  8. Remanufacturer
  9. Preprocessors of Single Use Devices
  10. Specification Developer
  11. U. S. manufacturer of export only devices

FDA Medical Device Registration and Listing Route

FDA Medical Device Registration

Those involved in the production and distribution of medical devices intended for commercial distribution in the U.S.A are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices.

Who Must Register, List and Pay the Fee >>

If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number/510k.

The requirements for FDA Medical Device Registration and listing based on the type of activity performed at that establishment. All initial importers must review the list of manufacturers of your imported devices.

All foreign establishments must review your list of known importers for each of your exported devices. If this information has not been entered previously, it must be entered during the annual registration period in order to complete registration for the current fiscal year.

Medical Device Registration and Device Listing Fees >>

Medical Device USFDA Registration & Listing Search >>

Any clarification please contacts us. Our consultant will contact you at the earliest.

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