SFDA Issues Recall System For Medical Devices
This article was originally published in PharmAsia News
China's State FDA released a draft on administrative measures for medical device recalls on March 19. The report specifies the responsibility, recall scope, time limit, classification and legal liabilities of medical device recalls, mainly aimed at device manufacturers. Recall falls into two types: voluntary and compulsory. Based on the potential safety hazard of medical devices, three categories of recall have been classified: devices that must be recalled within 24 hours, 48 hours and 72 hours. Industry analysts observe that as most local medical devices makers are small-scale enterprise, they may not be able to bear losses. However, the new recall system will have a profound impact on enhancing manufacturers' quality control and focus on their medical devices. (Click here for more - Chinese Language)
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