A procedure for shipping and distribution records is the most obvious quality system requirement that Initial Importers are required to have by the FDA. But how do you know what other requirements there are? The best way to determine this is to search each of the regulations for the keyword "importer." Specifically, there are five different regulations that you need to review: 1 - 21 CFR 820 - Quality system regulation & Quality management system regulation (February 2, 2026) 2 - 21 CFR 830 - Unique device identification 3 - 21 CFR 803 - Medical device reporting 4 - 21 CFR 806 - Medical devices; reports of corrections and removals 5 - 21 CFR 807 - Establishment registration and listing for device manufacturers and initial importers of devices Only one of these regulations specifically mentions importers in the title (i.e., 21 CFR 807), but there are other regulations on the list that specifically mention importers in the body of the regulations. In this live-streaming video, we'll go through each one and explain when the regulation applies to importers and if procedures are required.