Import/Export - Regulatory Requirements for Medical Devices

摘要

The materials in the publication cover the basic regulatory requirements that manufacturers must consider when they export or import a medical device. It is important to know these requirements, to determine which ones are pertinent to your particular situation, and to follow the proper sequence or timetable for fulfilling them. The term 'medical device' describes a large and diverse set of products. Regulation of these products is a challenging and complicated process, not only because of sheer volume and variety, but also because of their increasing importance in the delivery of patient health care. The materials printed here are drawn from ongoing Division of Small Manufacturers Assistance (DSMA) programs of information and education. They should prove useful as a general reference on import-export requirements. The basic overview provided here will help you get oriented and focus on further specific questions you may wish to ask. It is DSMA's mission to assist you and to identify ways of complying with FDA requirements. If you have a need for more technical or detailed information, DSMA will refer you to the appropriate authorities in the Department of Health and Human Services or to other government agencies that may be involved, such as the Department of Commerce.