Which quality system procedures do initial importers need?

The minimum requirements for an Initial Importer of medical devices is to have a procedure for distribution. You also must be registered with the FDA. You must identify, in your registration, which companies you are importing products from. You should also have an agreement with that company that defines which roles your company has.

When you receive complaints, you need to have defined whether you are the complaint file establishment or if the manufacturer will be. Our recommendation is to have the importer have a procedure for complaint handling and initiate the records, but the manufacturer will be assigned investigations. The complainant's communications will also be your responsibility.

You must assist the manufacturer in the event of a recall. You could incorporate instructions into your distribution procedure, but it is more likely it would be a separate work instruction. Ideally, the manufacturer will conduct a mock recall to make sure you are prepared.

You also are responsible for reporting in the event of a serious injury or death. If the adverse event is not reportable, you still must report it to the manufacturer so they can investigate and take necessary corrective actions.

If the device(s) you import requires installation, service, or training you may need to have procedures and records of those processes as well. Some of the service may identify device malfunction and require complaint investigations.

If you have any other questions about quality system requirements for an initial importer, please schedule a call with us: https://medicaldeviceacademy.com/cont...