Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.

In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.

• U.S. Facilities
  • Initial importers must identify the manufacturers of the devices they are importing.
  • A device must be listed if they fall under the any of the following:
    • Contract Manufacturer
    • Contract Sterilizer
    • Manufacturer
    • Relabeler / Repackager
    • Remanufacturer
    • Reprocessor of Single Use Device
    • Specification Developer
    • U. S. manufacturer of export only devices

     

   

• Non-U.S. Facilities
  • Must list devices, provide a U.S. Agent, and identify importers.

   

In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.

All facilities that fall under any of the following functions:

1. Contract Manufacturer
2. Contract Sterilizer
3. Foreign Exporter
4. Manufacturer
5. Relabeler / Repackager
6. Remanufacturer
7. Reprocessor of Single Use Device
8. Specification Developer
9. U.S. manufacturer of export only devices

Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.

1. Company function (activity)
2. Device product code
3. Proprietary names
4. Importer information

A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.