TJM Obtains FDA Registration

In order to provide a complete manufacturing and distribution service for medical devices, TJM Electronics just received its FDA registration to complement its ISO-13485 quality system certification.

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

 Medical Device Listing – 21CFR Part 807

Manufacturers must list their devices with the FDA. Establishments required to list their devices include:

  • manufacturers,
  • contract manufacturers that commercially distribute the device,
  • contract sterilizers that commercially distribute the device,
  • repackagers and relabelers,
  • specification developers,
  • reprocessors single-use devices,
  • remanufacturer
  • manufacturers of accessories and components sold directly to the end user
  • U.S. manufacturers of “export only” devices

Medical Device Listing