In the United States, the US Initial Importer assumes a strategic role not only in the import and customs clearance of the devices but also as responsible regulator for some activities. For example, the US initial Importer must:
- communicate to FDA all accidents or adverse events which caused (or contributed to) death or serious harm to the patient and which caused to the Manufacturer all malfunctions found on the imported device (21 CFR 803.40, 21 CFR 803.42);
- record, communicate and archive all non-conformities and customer reports;
- collaborate with the Manufacturer in the management of the recalls;
- preserve the safety and effectiveness of the device during the storage and handling of imported devices (21 CFR 820);
- ensure the traceability of imported devices (21 CFR 821).
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