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China State FDA Solicits Public Feedback On Registration Provisions For Medical Devices

This article was originally published in PharmAsia News

Executive Summary

China's State FDA is seeking public feedback on its revised provisions for medical device registration. The draft specifies that applicants should conduct research and risk analysis on the safety of their medical devices, with report submission on technical performance, risk management, product examination and self-audits on quality management systems. Compared with current provisions, the revised version toughens legal responsibility and punishment. For instance, if an applicant uses false documents or dishonest means, SFDA can reject the application, impose fines of RMB 100,000 to RMB 200,000 ($14,641 to $29,283) and revoke the registration rights for 10 years. Industry players say authorities should focus more on raising approval efficiency and standardizing the clinical trial foundation for medical devices. (Click here for more - Chinese language)

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