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2015

CFDA issues Good Supply Practice for Medical Devices

Published:2015-01-20
To strengthen the quality management of medical device distribution, standardize medical device distribution behaviors, and guarantee the safety and effectiveness of medical devices, China Food and Drug Administration (CFDA) formulated the Good Supply Practice for Medical Devices in accordance with the newly revised Regulations for the Supervision and Administration of Medical Devices and the Administrative Measures for the Supervision of Distribution of Medical Devices. The Good Supply Practice for Medical Devices was adopted at the 16th minister’s working meeting of CFDA in 2014, promulgated on December 12, 2014, and came into effect from the date of promulgation. Good Supply Practice for Medical Devices comprises 66 articles in nine chapters, which requires medical device distribution enterprises to set up and improve the quality management system in accordance with this document, and apply effective quality control measures in the purchase, acceptance, storage, sales, transportation, after-sales service of medical devices to guarantee the quality and safety of medical devices in distribution process.