Import of Medical Devices: A Workshop Manual

摘要

The manual covers the range of basic regulatory requirements that all manufacturers must consider when they begin to import a medical device. The materials it contains are useful for guidance and reference on establishment registration, device listing, labeling, premarket notification (510(k)), and premarket approval requirements, U.S. Customs' entry procedures, and other topics of significance to device manufacturers. The manual represents a revision and updating of the import section of the FDA publication 'Import/Export of Medical Device-A Workshop Manual,' HHS Publication FDA 83-4167, and includes current information on the Safe Medical Devices Act (SMDA) of 1990.