Global Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices. Sixth Edition

摘要

This is the sixth edition of Global Import Regulations for Pre-Owned Medical Devices, which was first issued in May 1999. This report seeks to collect and compile information on the regulations relating to the importation of pre-owned (used and refurbished) capital medical equipment in countries around the world. It also includes some information on market demand for such equipment. Although this report is intended to serve as a general reference, it is not a definitive study and data are either not available or incomplete for some countries. This report is formally updated periodically. This report does not attempt to address the issue of re-use of single-use devices (SUDs). Such re-use remains a controversial practice and poses different safety issues than pre-owned capital medical equipment, which is designed for use with multiple patients over many years. Moreover, single-use devices are typically reprocessed by or for the original purchaser and thus generally do not enter into international trade.